Pub Date : 2020-04-23DOI: 10.2174/2213476x07666200423081738
Shailesh Bhosale, K. Kant, D. Goyal, Anoop Kumar
Ranitidine is a well known H2 blocker antihistaminic drug used for symptomatic relief of heartburn, indigestion, acid indigestion, peptic ulcer and hyperacidity. However, On 13th September 2019, the United States Food and Drug Administration (USFDA) has given an alerting statement regarding the presence of nitrosamine impurity called N-nitrosodimethylamine (NDMA) in ranitidine containing products. Recently, some pharmaceutical companies have also recalled their ranitidine containing products from the market. Thus, there is a need to understand about these impurities in ranitidine containing products. The first part of this article highlights the mechanism of action of ranitidine in established therapeutic indications along with its adverse drug reactions and contraindications. Further, the introduction of genotoxic impurities in pharmaceutical products along with its types and mechanism of toxicity of ranitidine containing genotoxic impurity have been discussed.
{"title":"Genotoxic Impurities in Ranitidine Containing Products: An Overview","authors":"Shailesh Bhosale, K. Kant, D. Goyal, Anoop Kumar","doi":"10.2174/2213476x07666200423081738","DOIUrl":"https://doi.org/10.2174/2213476x07666200423081738","url":null,"abstract":"\u0000\u0000Ranitidine is a well known H2 blocker antihistaminic drug used for symptomatic relief\u0000of heartburn, indigestion, acid indigestion, peptic ulcer and hyperacidity. However, On 13th September\u00002019, the United States Food and Drug Administration (USFDA) has given an alerting\u0000statement regarding the presence of nitrosamine impurity called N-nitrosodimethylamine\u0000(NDMA) in ranitidine containing products. Recently, some pharmaceutical companies have also\u0000recalled their ranitidine containing products from the market. Thus, there is a need to understand\u0000about these impurities in ranitidine containing products. The first part of this article highlights the\u0000mechanism of action of ranitidine in established therapeutic indications along with its adverse\u0000drug reactions and contraindications. Further, the introduction of genotoxic impurities in pharmaceutical\u0000products along with its types and mechanism of toxicity of ranitidine containing genotoxic\u0000impurity have been discussed.\u0000","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"70 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90785435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-03DOI: 10.2174/2213476X06666190624152156
S. Jani, Nilesh Patel, Urvi Chotaliya, Ashok R. Patel
Literature review suggested that regulatory guidelines should be harmonized for better processing of applications and for the upliftment of the regulatory field. Therefore it was thought worthwhile to compare the guidelines for countries where there is requirement of harmonization. Kosovo, Ukraine and Serbia were selected because of being European countries and still they are not a part of EU. Kosovo, Ukraine and Serbia are small countries of Europe but they are not members of European Union. They have their own guidelines for the submission of MAA for marketing of pharmaceuticals and medical devices. They are trying to obtain the EU membership and therefore it was worthwhile to compare the guidelines of these countries. The registration process of pharmaceuticals in Kosovo, Ukraine and Serbia was studied throughly. Along with it, the guidelines for European Union were also studied. A comparison of guidelines of all the three countries with the guidelines of European Union for pharmaceuticals was carried out. The comparison of guidelines showed that there are still some changes needed in the guidelines of Kosovo, Ukraine and Serbia before they can merge with the guidelines of European Union. Some of the points in the guidelines are very different from the guidelines of EU. So it was worthwile to study the regulatory requirements of pharmaceuticals in Non- European Union Member States Kosovo, Ukraine and Serbia.
{"title":"Comparison of Regulatory Requirements for Pharmaceuticals in Non- European Union Member States Kosovo, Ukraine and Serbia","authors":"S. Jani, Nilesh Patel, Urvi Chotaliya, Ashok R. Patel","doi":"10.2174/2213476X06666190624152156","DOIUrl":"https://doi.org/10.2174/2213476X06666190624152156","url":null,"abstract":"\u0000\u0000Literature review suggested that regulatory guidelines should be harmonized\u0000for better processing of applications and for the upliftment of the regulatory field. Therefore\u0000it was thought worthwhile to compare the guidelines for countries where there is requirement of\u0000harmonization. Kosovo, Ukraine and Serbia were selected because of being European countries\u0000and still they are not a part of EU.\u0000\u0000\u0000\u0000Kosovo, Ukraine and Serbia are small countries of Europe but they are not members\u0000of European Union. They have their own guidelines for the submission of MAA for marketing\u0000of pharmaceuticals and medical devices. They are trying to obtain the EU membership and\u0000therefore it was worthwhile to compare the guidelines of these countries.\u0000\u0000\u0000\u0000The registration process of pharmaceuticals in Kosovo, Ukraine and Serbia was studied\u0000throughly. Along with it, the guidelines for European Union were also studied. A comparison of\u0000guidelines of all the three countries with the guidelines of European Union for pharmaceuticals\u0000was carried out.\u0000\u0000\u0000\u0000The comparison of guidelines showed that there are still some changes needed in the\u0000guidelines of Kosovo, Ukraine and Serbia before they can merge with the guidelines of European\u0000Union. Some of the points in the guidelines are very different from the guidelines of EU.\u0000\u0000\u0000\u0000So it was worthwile to study the regulatory requirements of pharmaceuticals in Non-\u0000European Union Member States Kosovo, Ukraine and Serbia.\u0000","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"108 1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89709598","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-03DOI: 10.2174/2213476x06666190916122404
Kunta N. Reddy, S. G. Vasantharaju
A DMF consists of confidential information, usually related to Chemistry, Manufacturing and Control (CMC) of the drug substance. DMF is prepared and submitted by the pharmaceutical manufacturer solely to the regulatory authority of the respected country where he wants to market. Compare the regulations of the emerging markets with that of a regulated market and to highlight the stringent requirements imposed by emerging authorities. The similarities and differences of the requirements for filing a DMF in emerging markets are compared against the regulated market. The method carried out for every single study follows some patterns and certain pathways in order to reach its target. Method begins with scope and objective of regulatory perspective of DMF filing requirements for USA, China, Brazil and Korea. The information was collected from Regulatory authorities, Legislations, Guidelines and Experts opinion. Regulatory requirements for filing a DMF for API registration vary from country to country. Even though a standard ICH-CTD format is available and most widely followed, there are some specific requirements recommended by drug authorities which are mandatory to be provided while filing to that particular country. Based on the current study it is clear that emerging markets possess more stringent requirements for API approval as compared to the regulatory market but the dispute is that the emerging markets do not have harmonized guidelines and are not transparent enough.
{"title":"Comparison of Regulatory Requirements for Filing Drug Master File (DMF) in Emerging Markets - China, Brazil & South Korea","authors":"Kunta N. Reddy, S. G. Vasantharaju","doi":"10.2174/2213476x06666190916122404","DOIUrl":"https://doi.org/10.2174/2213476x06666190916122404","url":null,"abstract":"\u0000\u0000A DMF consists of confidential information, usually related to Chemistry, Manufacturing\u0000and Control (CMC) of the drug substance. DMF is prepared and submitted by the pharmaceutical\u0000manufacturer solely to the regulatory authority of the respected country where he wants to market.\u0000\u0000\u0000\u0000Compare the regulations of the emerging markets with that of a regulated market and to highlight\u0000the stringent requirements imposed by emerging authorities. The similarities and differences of the\u0000requirements for filing a DMF in emerging markets are compared against the regulated market.\u0000\u0000\u0000\u0000The method carried out for every single study follows some patterns and certain pathways in\u0000order to reach its target. Method begins with scope and objective of regulatory perspective of DMF filing\u0000requirements for USA, China, Brazil and Korea. The information was collected from Regulatory authorities,\u0000Legislations, Guidelines and Experts opinion.\u0000\u0000\u0000\u0000Regulatory requirements for filing a DMF for API registration vary from country to country.\u0000Even though a standard ICH-CTD format is available and most widely followed, there are some specific\u0000requirements recommended by drug authorities which are mandatory to be provided while filing to that\u0000particular country.\u0000\u0000\u0000\u0000Based on the current study it is clear that emerging markets possess more stringent requirements\u0000for API approval as compared to the regulatory market but the dispute is that the emerging markets\u0000do not have harmonized guidelines and are not transparent enough.\u0000","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"97 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80552535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Najwa Alfarra, Nouf Aldhawyan, Sammah Alharbi, Mohammed Sheeha
BACKGROUND Nearly nine months have passed since the emergence of the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), which caused the rapidly spreading Coronavirus Disease 2019 (COVID-19) pandemic. In Saudi Arabia, unprecedented precautionary strict measures were applied to prevent virus entry to the country or to mitigate its impact when it arrives. The physical rehabilitation is the 3rd largest profession in the area of healthcare and is the most representative profession in the area of rehabilitation in Saudi Arabia. Physical rehabilitation services provide the development, maintenance, and recovery of people’s movement and functional ability, improving their quality of life. In this way, many hospitalized patients in the acute phase of COVID-19, as well as chronic patients, need physical rehabilitation services. This study aimed to determine the number of therapists/ clinicians who interrupted their services because of the COVID-19 pandemic and to verify the procedures adopted by the therapists/clinicians to continue serving and supporting their patients. METHODS The sample comprised 46 therapists/clinicians who worked in King Faisal Specialist Hospital and Research Center (KFSH&RC), 19 (41.4%) males and 27 (58.6%) females. The measurement instrument was an on-line survey questionnaire applied mid-July to mid-August 2020 through email. The questionnaires consisted of four primary sections. The first section gathered information on respondents' sociodemographic characteristics. The second section assessed respondents ' years of professional experience and area of specialty. The third section assessed respondents ' work load on daily bases pre/post COVID-19 crisis. The final section of the questionnaire assessed the benefits and barriers of telehealth, therapist opinion about how was the department/organization handled this pandemic issue, and to add their recommendation to improve the service. RESULTS Out of the 46 therapists/clinicians, 37 (80.4%) interrupted their work activities because of the pandemic and 9 (19.6%) continue with the existing daily practice. The number of patients seen/day before pandemic decreased compare to pre pandemic by21.7%, in arrange of 15 patients/day to zero patient/day by 26.1%, that led to change the way of therapists daily practice such as seven therapists shifted their clinics to virtual clinics, and almost most of the therapists (n= 32) continue working in inpatient ward, taking in their considerations the main measures that was adopted by the organization, when they deal with the direct patient contact which included: hand washing, mask use, material disinfection and gloves. The three administrative respondents work on quality issues, managerial guidelines and research. While the four orthotics/ prosthetics clinicians shifted their work to fabricate medical supportive devices to be used for the patients. Seven therapists shift their clinics to virtual visits, and they found it very convenient t
{"title":"Perception of Healthcare Providers in Agile Environment Imposed by the COVID-19","authors":"Najwa Alfarra, Nouf Aldhawyan, Sammah Alharbi, Mohammed Sheeha","doi":"10.31579/2693-4779/027","DOIUrl":"https://doi.org/10.31579/2693-4779/027","url":null,"abstract":"BACKGROUND Nearly nine months have passed since the emergence of the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), which caused the rapidly spreading Coronavirus Disease 2019 (COVID-19) pandemic. In Saudi Arabia, unprecedented precautionary strict measures were applied to prevent virus entry to the country or to mitigate its impact when it arrives. The physical rehabilitation is the 3rd largest profession in the area of healthcare and is the most representative profession in the area of rehabilitation in Saudi Arabia. Physical rehabilitation services provide the development, maintenance, and recovery of people’s movement and functional ability, improving their quality of life. In this way, many hospitalized patients in the acute phase of COVID-19, as well as chronic patients, need physical rehabilitation services. This study aimed to determine the number of therapists/ clinicians who interrupted their services because of the COVID-19 pandemic and to verify the procedures adopted by the therapists/clinicians to continue serving and supporting their patients. METHODS The sample comprised 46 therapists/clinicians who worked in King Faisal Specialist Hospital and Research Center (KFSH&RC), 19 (41.4%) males and 27 (58.6%) females. The measurement instrument was an on-line survey questionnaire applied mid-July to mid-August 2020 through email. The questionnaires consisted of four primary sections. The first section gathered information on respondents' sociodemographic characteristics. The second section assessed respondents ' years of professional experience and area of specialty. The third section assessed respondents ' work load on daily bases pre/post COVID-19 crisis. The final section of the questionnaire assessed the benefits and barriers of telehealth, therapist opinion about how was the department/organization handled this pandemic issue, and to add their recommendation to improve the service. RESULTS Out of the 46 therapists/clinicians, 37 (80.4%) interrupted their work activities because of the pandemic and 9 (19.6%) continue with the existing daily practice. The number of patients seen/day before pandemic decreased compare to pre pandemic by21.7%, in arrange of 15 patients/day to zero patient/day by 26.1%, that led to change the way of therapists daily practice such as seven therapists shifted their clinics to virtual clinics, and almost most of the therapists (n= 32) continue working in inpatient ward, taking in their considerations the main measures that was adopted by the organization, when they deal with the direct patient contact which included: hand washing, mask use, material disinfection and gloves. The three administrative respondents work on quality issues, managerial guidelines and research. While the four orthotics/ prosthetics clinicians shifted their work to fabricate medical supportive devices to be used for the patients. Seven therapists shift their clinics to virtual visits, and they found it very convenient t","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"27 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84167380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Consuming scarce and poorly diversified diet, along with inadequate breastfeeding, contribute seriously to the complete scope of child undernutrition like stunting, wasting, underweight and micronutrient deficiency. Objective: To determine the association between dietary diversity score (DDS) and nutritional status among children aged 24 to 59 months in Haromaya district, Ethiopia. Methods: Children aged 24-59 months (N= 453) were enrolled in this cross-sectional study with a representative sample of households selected by a multistage sampling procedure in Haromaya district. Anthropometry and 24hr dietary recall were administered. Multinomial logistic regression models were applied to select variables that are candidate for multivariable model. Structural equation modeling was applied to test the mediatory effect of DDS on the relationship between household food insecurity (HFI) and child nutritional status. Results: The mean DDS was 3.62 (SD 1.09), and 50% of the children indicated poor and average DDS with only 20% children in very good DDS. By logistic regression analysis and after adjusting for the confounding factors, poor DDS was highly significant predictor of wasting, stunting and underweight (AOR = 4.09, C.I = 1.31 - 12.76, p = .01), (AOR = 2.28, C.I = 1.11 - 4.69, p = .03) and (AOR = 2.48, C.I = 1.17 - 5.24, p = .02) respectively. HFI had a significant direct effect on wasting though no significant indirect effect on wasting through mediation variable, DDS, (β1 reduced from 0.06 (S.E. = 0.027, p < .05) to 0.05 (S.E. = 0.028, p > .05). Conclusion: Poor DDS was a predictor of wasting, stunting and underweight. Additionally, DDS had a role in the association between HFI and nutritional status.
背景:饮食缺乏和不多样化，加上母乳喂养不足，严重导致儿童营养不良，如发育迟缓、消瘦、体重不足和微量营养素缺乏症。目的:了解埃塞俄比亚Haromaya地区24 ~ 59月龄儿童膳食多样性评分(DDS)与营养状况的关系。方法:采用多阶段抽样方法在哈罗玛亚区选取具有代表性的家庭样本，选取24-59个月的儿童(N= 453)进行横断面研究。进行人体测量和24小时饮食回忆。采用多项逻辑回归模型选择多变量模型的候选变量。采用结构方程模型检验DDS在家庭粮食不安全(HFI)与儿童营养状况关系中的中介作用。结果:平均DDS为3.62 (SD 1.09)， 50%的患儿DDS较差，一般，仅20%的患儿DDS很好。经logistic回归分析和校正混杂因素后，DDS差是消瘦、发育迟缓和体重不足的极显著预测因子(AOR = 4.09, ci = 1.31 ~ 12.76, p = 0.01)、(AOR = 2.28, ci = 1.11 ~ 4.69, p = 0.03)和(AOR = 2.48, ci = 1.17 ~ 5.24, p = 0.02)。通过中介变量DDS (β1)， HFI对浪费有显著的直接影响，但对浪费没有显著的间接影响(从0.06 (S.E. = 0.027, p < 0.05)降低到0.05 (S.E. = 0.028, p > 0.05)。结论:DDS差是消瘦、发育迟缓和体重不足的预测因素。此外，DDS在HFI和营养状况之间的关联中起作用。
{"title":"Dietary Diversity May Play A Mediatory Role on the Association between Household Food Insecurity and Nutritional Status among Children Aged 24-59 Months","authors":"Ahmed A Abdurahman","doi":"10.31579/crct.2019/001","DOIUrl":"https://doi.org/10.31579/crct.2019/001","url":null,"abstract":"Background: Consuming scarce and poorly diversified diet, along with inadequate breastfeeding, contribute seriously to the complete scope of child undernutrition like stunting, wasting, underweight and micronutrient deficiency. Objective: To determine the association between dietary diversity score (DDS) and nutritional status among children aged 24 to 59 months in Haromaya district, Ethiopia. Methods: Children aged 24-59 months (N= 453) were enrolled in this cross-sectional study with a representative sample of households selected by a multistage sampling procedure in Haromaya district. Anthropometry and 24hr dietary recall were administered. Multinomial logistic regression models were applied to select variables that are candidate for multivariable model. Structural equation modeling was applied to test the mediatory effect of DDS on the relationship between household food insecurity (HFI) and child nutritional status. Results: The mean DDS was 3.62 (SD 1.09), and 50% of the children indicated poor and average DDS with only 20% children in very good DDS. By logistic regression analysis and after adjusting for the confounding factors, poor DDS was highly significant predictor of wasting, stunting and underweight (AOR = 4.09, C.I = 1.31 - 12.76, p = .01), (AOR = 2.28, C.I = 1.11 - 4.69, p = .03) and (AOR = 2.48, C.I = 1.17 - 5.24, p = .02) respectively. HFI had a significant direct effect on wasting though no significant indirect effect on wasting through mediation variable, DDS, (β1 reduced from 0.06 (S.E. = 0.027, p < .05) to 0.05 (S.E. = 0.028, p > .05). Conclusion: Poor DDS was a predictor of wasting, stunting and underweight. Additionally, DDS had a role in the association between HFI and nutritional status.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73338233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-11-30DOI: 10.2174/2213476x06666190906152404
Vikram, A. Deep, Manita
Biological products comprise the most complex and diverse types of drugs that are made by living cells. The use of biological products has increased significantly in recent decades and has contributed significantly to improving the efficacy of treatment in many diseases. Patent protection for pharmaceutical products, including biological products, generally expires about 20 years after development. Expiration of patents of biological innovative medicines allows regulatory authorities to approve copies of biological medicines, such as medicines called similar biological products (biosimilar) and to enter in clinical use. Biosimilar products are comparable but not identical with innovator biological products and are not a generic version of the innovator biological product. While biosimilars are subjected to rigorous characterization and clinical trials to demonstrate their safety and efficacy, in the case of biosimilars certain regulatory requirements apply for registration. Biosimilars are very complex and large molecules and minor changes in the manufacturing process can have important implications in their safety and efficacy profiles. To ensure that biosimilar reaches their potential in clinical application, intensive Pharmacovigilance system and risk management plan must be established to demonstrate the true similarity between the biosimilar products and original biological products. Biosimilars are part of the growing sector of the pharmaceutical industry and normally used by human beings since manufacturers of biosimilars face some challenges in regulatory approval and manufacturing of biosimilars in the European Union. The current manuscript will provide the information regarding the regulation of biosimilar products with guidelines and challenges faced by manufacturers during approved and manufacturing of biosimilar products in the European Union. This manuscript also provides the status of approved and rejected biosimilars by EMA (European Medicine Agency). Biosimilars may reduce costs when patent protection of biological products expires and compared to the original products, savings are not as large as seen with traditional generics. In the coming years, there will be an increasing number of biological and biosimilar products available on the market, highlighting the need for specific short and long term post-marketing surveillance programs for these medicines. It is essential to understand how the concept of compatibility, interchangeability will be managed and regulated in the future. An important aspect for future a high quality, clinical and non-clinical studies will be conducted to evaluate the safety and efficacy of biosimilars. Scientific guidelines on biosimilar issued by the EMA (European Medicine Agency) that established a process to demonstrate the similarity between a biosimilar product and the innovator reference product.
{"title":"Regulation and Challenges of Biosimilars in European Union","authors":"Vikram, A. Deep, Manita","doi":"10.2174/2213476x06666190906152404","DOIUrl":"https://doi.org/10.2174/2213476x06666190906152404","url":null,"abstract":"\u0000\u0000 Biological products comprise the most complex and diverse types of\u0000drugs that are made by living cells. The use of biological products has increased significantly in\u0000recent decades and has contributed significantly to improving the efficacy of treatment in many\u0000diseases. Patent protection for pharmaceutical products, including biological products, generally\u0000expires about 20 years after development. Expiration of patents of biological innovative medicines\u0000allows regulatory authorities to approve copies of biological medicines, such as medicines called\u0000similar biological products (biosimilar) and to enter in clinical use. Biosimilar products are comparable\u0000but not identical with innovator biological products and are not a generic version of the\u0000innovator biological product. While biosimilars are subjected to rigorous characterization and\u0000clinical trials to demonstrate their safety and efficacy, in the case of biosimilars certain regulatory\u0000requirements apply for registration. Biosimilars are very complex and large molecules and minor\u0000changes in the manufacturing process can have important implications in their safety and efficacy\u0000profiles. To ensure that biosimilar reaches their potential in clinical application, intensive Pharmacovigilance\u0000system and risk management plan must be established to demonstrate the true similarity\u0000between the biosimilar products and original biological products. Biosimilars are part of the\u0000growing sector of the pharmaceutical industry and normally used by human beings since manufacturers\u0000of biosimilars face some challenges in regulatory approval and manufacturing of biosimilars\u0000in the European Union.\u0000\u0000\u0000\u0000The current manuscript will provide the information regarding the regulation of\u0000biosimilar products with guidelines and challenges faced by manufacturers during approved and\u0000manufacturing of biosimilar products in the European Union. This manuscript also provides the\u0000status of approved and rejected biosimilars by EMA (European Medicine Agency).\u0000\u0000\u0000\u0000 Biosimilars may reduce costs when patent protection of biological products expires\u0000and compared to the original products, savings are not as large as seen with traditional generics. In\u0000the coming years, there will be an increasing number of biological and biosimilar products available\u0000on the market, highlighting the need for specific short and long term post-marketing surveillance\u0000programs for these medicines. It is essential to understand how the concept of compatibility,\u0000interchangeability will be managed and regulated in the future. An important aspect for future a\u0000high quality, clinical and non-clinical studies will be conducted to evaluate the safety and efficacy\u0000of biosimilars. Scientific guidelines on biosimilar issued by the EMA (European Medicine\u0000Agency) that established a process to demonstrate the similarity between a biosimilar product and\u0000the innovator reference product.\u0000","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"17 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87679059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-11-30DOI: 10.2174/2213476X06666190821095407
Manita, A. Deep, Vikram, A. Rana, P. C. Sharma
Medical devices are the machine, tool, instrument, apparatus, implant, calibrator in vitro, software, the similar or related object intended for use by the manufacturer alone or in combination becoming increasingly important in the healthcare sector as these are used to diagnosis, control, prevention or treatment of an illness. Safety of the world population is the highest priority in order to launch new medical devices for the treatment and diagnostic of several diseases. New innovation in industries and regulations work together to provide devices for different world market and to improve quality and safety of exiting devices in the market. The main key for devices is to classify the determination of actual regulatory pathway which ensures the safety standards and other regulatory requirements in a specific country. We perform clinical trials for medical device which are quite different from the clinical trials performed for drug analysis. For any high-risk devices, the new EU law states that the manufacturer has to prepare a complete summary for their evidence. The clinical trials regulation provides more transparency on clinical trials data. Complete transparency is required for the maximum possibility of informed decisions in order to use new medical devices. The current manuscript will provide the information regarding the regulatory framework for the approval of medical devices and clinical investigation of medical device in European Union and comparison of approval process of medical device in USA, EU and India. The aim of this paper is to provide an overview of the most suitable and emerging requirements that manufacturers need for introducing their medical devices in the market in compliance with the MDR regulations. The proposal for a modified regulation of medical devices aims to ensure more robust clinical data in support of the CE marking applications of the medical device. The clinical investigation requirements will be mandatory, and there will be an obligation to demonstrate the clinical benefits of the device and provide a rigorous equivalence test if the assessment is based on comparison devices. The new European legislation should require the premarket demonstration of clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical review, preferably centralized.
{"title":"Regulation and Clinical Investigation of Medical Device in the European Union","authors":"Manita, A. Deep, Vikram, A. Rana, P. C. Sharma","doi":"10.2174/2213476X06666190821095407","DOIUrl":"https://doi.org/10.2174/2213476X06666190821095407","url":null,"abstract":"\u0000\u0000Medical devices are the machine, tool, instrument, apparatus, implant,\u0000calibrator in vitro, software, the similar or related object intended for use by the manufacturer\u0000alone or in combination becoming increasingly important in the healthcare sector as these are used\u0000to diagnosis, control, prevention or treatment of an illness. Safety of the world population is the\u0000highest priority in order to launch new medical devices for the treatment and diagnostic of several\u0000diseases. New innovation in industries and regulations work together to provide devices for different\u0000world market and to improve quality and safety of exiting devices in the market. The main key\u0000for devices is to classify the determination of actual regulatory pathway which ensures the safety\u0000standards and other regulatory requirements in a specific country. We perform clinical trials for\u0000medical device which are quite different from the clinical trials performed for drug analysis. For\u0000any high-risk devices, the new EU law states that the manufacturer has to prepare a complete\u0000summary for their evidence. The clinical trials regulation provides more transparency on clinical\u0000trials data. Complete transparency is required for the maximum possibility of informed decisions\u0000in order to use new medical devices.\u0000\u0000\u0000\u0000The current manuscript will provide the information regarding the regulatory framework\u0000for the approval of medical devices and clinical investigation of medical device in European\u0000Union and comparison of approval process of medical device in USA, EU and India. The aim of\u0000this paper is to provide an overview of the most suitable and emerging requirements that manufacturers\u0000need for introducing their medical devices in the market in compliance with the MDR regulations.\u0000\u0000\u0000\u0000The proposal for a modified regulation of medical devices aims to ensure more robust\u0000clinical data in support of the CE marking applications of the medical device. The clinical investigation\u0000requirements will be mandatory, and there will be an obligation to demonstrate the\u0000clinical benefits of the device and provide a rigorous equivalence test if the assessment is based on\u0000comparison devices. The new European legislation should require the premarket demonstration of\u0000clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical\u0000review, preferably centralized.\u0000","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"57 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80492638","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-11-30DOI: 10.2174/2213476X06666190823142403
Anmol Wadhwa, S. Talegaonkar, H. Popli
Medical device acceptance of patients has grown considerably in recent years. This has question the effectiveness of the current regulatory frameworks to ensure the performance, safety, and quality of new devices. This article focuses on the methodical overview on hip and knee joint replacement medical devices evaluating the procedure and proper analysis of medical device regulation in three jurisdictions i.e. the United States of America (USA), EUROPE and INDIA, exploring reforms been laid to stabilize and meet the requirements of existing systems, and further analyse the additional actions which should be employed to fully meet this ultimate goal. We analysed the hip and knee joint replacement medical device regulation system through a secondary research in United States, Europe and India in compliance with the updated national regulatory authority’s legislative documents and requirements. These three regulatory systems vary in their working, organization, acceptance for their specific pre- and post-market evidence requirements, and transparency of process. The most challenging factor remains the same for the countries which are to make sure safety and effectiveness of devices, proper monitoring of its use and important compliance information readiness employing quality management system towards new findings and acceptance for the users. A case study of Johnson & Johnson ASR Implant was also studied, highlighting the major reforms required and the reforms introduced in the United States, Europe and India. Thus, quality and safety reforms are made to strengthen the premarket compliance requirements, enhancing the need of post-market regulation through proper traceability and monitoring of devices by employing the functioning medical device registry. Recent reforms address the major challenges in device regulation, highlighting the need to create connecting points between the device identifier system and existing data collection tools, such as electronic health records, and maintaining effective and up to date use of registries to ensure post-market use of new and existing devices.
{"title":"A Regulatory Overview of Hip And Knee Joint Replacement Devices","authors":"Anmol Wadhwa, S. Talegaonkar, H. Popli","doi":"10.2174/2213476X06666190823142403","DOIUrl":"https://doi.org/10.2174/2213476X06666190823142403","url":null,"abstract":"\u0000\u0000Medical device acceptance of patients has grown considerably in recent\u0000years. This has question the effectiveness of the current regulatory frameworks to ensure the performance,\u0000safety, and quality of new devices. This article focuses on the methodical overview on\u0000hip and knee joint replacement medical devices evaluating the procedure and proper analysis of\u0000medical device regulation in three jurisdictions i.e. the United States of America (USA), EUROPE\u0000and INDIA, exploring reforms been laid to stabilize and meet the requirements of existing systems,\u0000and further analyse the additional actions which should be employed to fully meet this ultimate\u0000goal.\u0000\u0000\u0000\u0000 We analysed the hip and knee joint replacement medical device regulation system\u0000through a secondary research in United States, Europe and India in compliance with the updated\u0000national regulatory authority’s legislative documents and requirements.\u0000\u0000\u0000\u0000These three regulatory systems vary in their working, organization, acceptance for their\u0000specific pre- and post-market evidence requirements, and transparency of process. The most challenging\u0000factor remains the same for the countries which are to make sure safety and effectiveness\u0000of devices, proper monitoring of its use and important compliance information readiness employing\u0000quality management system towards new findings and acceptance for the users. A case study\u0000of Johnson & Johnson ASR Implant was also studied, highlighting the major reforms required and\u0000the reforms introduced in the United States, Europe and India. Thus, quality and safety reforms\u0000are made to strengthen the premarket compliance requirements, enhancing the need of post-market\u0000regulation through proper traceability and monitoring of devices by employing the functioning\u0000medical device registry.\u0000\u0000\u0000\u0000Recent reforms address the major challenges in device regulation, highlighting the\u0000need to create connecting points between the device identifier system and existing data collection\u0000tools, such as electronic health records, and maintaining effective and up to date use of registries\u0000to ensure post-market use of new and existing devices.\u0000","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90549261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-11-30DOI: 10.2174/2213476x06666190807095506
Vibhu Yadav, A. Mittal, Parikshit Bansal, S. Singh
To present an overview of import need for wound care and burn dressings in India. This article provides a complete analysis of the import-export value of wound care and burn dressings in India. It helps in preparing growth strategies, knowledge about leading players, recent developments, business strategies, and manufacturing status of the wound care and burn dressings in India. A trend analysis of import-export was carried out for wound and burn dressings in India. Raw data of the years (2008-2017) were collected from various market research analysis sites and import need was identified. The detailed analysis reveals that India is a growing market for wound and burn dressings and spends a lot of the exchequer on importing the subject commodity. Wound dressing export is averaged to the same from 2013 to 2017. India saw a rise in wound dressing export after 2012. India saw a rise of wound dressing import over the past 10 years. It averaged 502.6 million from 2008 to 2017 and it reached its all-time high of 765 million in 2016. The import value was found quite high as compared to export. The report of import and export analysis very clearly highlights that there is a strong demand for dressings in the country and due to lack of own manufacturers of such dressing in India, these are imported. Since these products are expensive, there is a large outflow of Indian currency due to imports. It is imperative that such products get government attention and should be manufactured within the country.
{"title":"Import Need for Wound Care and Burn Dressings in India: A Bioeconomic Challenge","authors":"Vibhu Yadav, A. Mittal, Parikshit Bansal, S. Singh","doi":"10.2174/2213476x06666190807095506","DOIUrl":"https://doi.org/10.2174/2213476x06666190807095506","url":null,"abstract":"\u0000\u0000To present an overview of import need for wound care and burn dressings in\u0000India. This article provides a complete analysis of the import-export value of wound care and burn\u0000dressings in India. It helps in preparing growth strategies, knowledge about leading players, recent\u0000developments, business strategies, and manufacturing status of the wound care and burn dressings\u0000in India.\u0000\u0000\u0000\u0000A trend analysis of import-export was carried out for wound and burn dressings in India.\u0000Raw data of the years (2008-2017) were collected from various market research analysis sites\u0000and import need was identified.\u0000\u0000\u0000\u0000 The detailed analysis reveals that India is a growing market for wound\u0000and burn dressings and spends a lot of the exchequer on importing the subject commodity. Wound\u0000dressing export is averaged to the same from 2013 to 2017. India saw a rise in wound dressing export\u0000after 2012. India saw a rise of wound dressing import over the past 10 years. It averaged\u0000502.6 million from 2008 to 2017 and it reached its all-time high of 765 million in 2016. The import\u0000value was found quite high as compared to export.\u0000\u0000\u0000\u0000The report of import and export analysis very clearly highlights that there is a strong\u0000demand for dressings in the country and due to lack of own manufacturers of such dressing in India,\u0000these are imported. Since these products are expensive, there is a large outflow of Indian currency\u0000due to imports. It is imperative that such products get government attention and should be\u0000manufactured within the country.\u0000","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"44 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73413299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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