Pub Date : 2009-06-01DOI: 10.1080/10601330902905887
S. Vangani, Xiaoling Li, Peter Zhou, M. Del-Barrio, R. Chiu, Nina S. Cauchon, P. Gao, Cesar Medina, B. Jasti
A novel in-vitro dissolution system based on the principle of flow-through technique has been designed to evaluate the in-vitro release rate of poorly water-soluble compounds. The flow through apparatus (USP 4) has been coupled with the compendial dissolution apparatus (USP apparatus 2). A bi-phasic dissolution medium is used to achieve sink conditions. The dissolved drug is continuously removed from the aqueous phase into the organic phase of the dissolution medium, mimicking the process of absorption in the systemic circulation. The in vitro release profiles obtained from this dissolution model was able to distinguish the formulation changes of several poorly water-soluble drugs from their dosage forms. For AMG 517, the model drug, excellent rank order correlation has been obtained between the in-vitro release and the in-vivo absorption of the drug from several different dosage forms and their formulations. In addition, for several commercial formulations, the model successfully discriminated between the bioequivalent and non-bioequivalent formulations.
{"title":"Dissolution of poorly water-soluble drugs in biphasic media using USP 4 and fiber optic system","authors":"S. Vangani, Xiaoling Li, Peter Zhou, M. Del-Barrio, R. Chiu, Nina S. Cauchon, P. Gao, Cesar Medina, B. Jasti","doi":"10.1080/10601330902905887","DOIUrl":"https://doi.org/10.1080/10601330902905887","url":null,"abstract":"A novel in-vitro dissolution system based on the principle of flow-through technique has been designed to evaluate the in-vitro release rate of poorly water-soluble compounds. The flow through apparatus (USP 4) has been coupled with the compendial dissolution apparatus (USP apparatus 2). A bi-phasic dissolution medium is used to achieve sink conditions. The dissolved drug is continuously removed from the aqueous phase into the organic phase of the dissolution medium, mimicking the process of absorption in the systemic circulation. The in vitro release profiles obtained from this dissolution model was able to distinguish the formulation changes of several poorly water-soluble drugs from their dosage forms. For AMG 517, the model drug, excellent rank order correlation has been obtained between the in-vitro release and the in-vivo absorption of the drug from several different dosage forms and their formulations. In addition, for several commercial formulations, the model successfully discriminated between the bioequivalent and non-bioequivalent formulations.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"22 1","pages":"19 - 8"},"PeriodicalIF":0.0,"publicationDate":"2009-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83556508","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 : 2009-06-01DOI: 10.1080/10601330902911893
Jean-Marc C. Haeusler
Background: The value of training in Good Clinical Practice (GCP) for clinical research professionals is unknown. The objective of this study was to assess the impact of formal training in GCP on the quality of clinical trials. Methods: Retrospective analysis of data collected from four multicenter trials conducted in the US in 2008. Certification as Physician Investigator (CPI) or Clinical Research Coordinator (CCRC) was used as proof of formal training in GCP. Protocol adherence was used as a proxy for the quality of clinical trials and quantified by the number of protocol deviations. The primary variable for analysis was the number of protocol deviations per randomized subject and site. Results: A total of 1,418 subjects were randomized by 101 investigators (29% CPI) and 109 clinical research coordinators (29% CCRC), with 520 protocol deviations. Compared to “no certification”, the Odds Ratios (OR) for the incidence of protocol deviations were OR = 1.20 (95% Confidence Interval [0.852–1.688]; p NS) for “CCRC-only”, OR = 0.70 ([0.513–0.953]; p = 0.0256) for “CPI-only”, and OR = 0.37 ([0.273–0.507]; p < 0.0001) for “CCRC + CPI”. Conclusions: This pilot study showed that formal training in GCP has the potential to improve protocol adherence and clinical trial quality.
{"title":"Certification in good clinical practice and clinical trial quality: A retrospective analysis of protocol adherence in four multicenter trials in the USA","authors":"Jean-Marc C. Haeusler","doi":"10.1080/10601330902911893","DOIUrl":"https://doi.org/10.1080/10601330902911893","url":null,"abstract":"Background: The value of training in Good Clinical Practice (GCP) for clinical research professionals is unknown. The objective of this study was to assess the impact of formal training in GCP on the quality of clinical trials. Methods: Retrospective analysis of data collected from four multicenter trials conducted in the US in 2008. Certification as Physician Investigator (CPI) or Clinical Research Coordinator (CCRC) was used as proof of formal training in GCP. Protocol adherence was used as a proxy for the quality of clinical trials and quantified by the number of protocol deviations. The primary variable for analysis was the number of protocol deviations per randomized subject and site. Results: A total of 1,418 subjects were randomized by 101 investigators (29% CPI) and 109 clinical research coordinators (29% CCRC), with 520 protocol deviations. Compared to “no certification”, the Odds Ratios (OR) for the incidence of protocol deviations were OR = 1.20 (95% Confidence Interval [0.852–1.688]; p NS) for “CCRC-only”, OR = 0.70 ([0.513–0.953]; p = 0.0256) for “CPI-only”, and OR = 0.37 ([0.273–0.507]; p < 0.0001) for “CCRC + CPI”. Conclusions: This pilot study showed that formal training in GCP has the potential to improve protocol adherence and clinical trial quality.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"20 1","pages":"20 - 23"},"PeriodicalIF":0.0,"publicationDate":"2009-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86811145","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 : 2009-05-01DOI: 10.1080/10601330902852725
Jonathon M Parker, E. Larrat
Objective: To determine physicians’ knowledge and attitudes of medico-legal issues regarding drug scheduling. Methods: The cross sectional survey was designed to assess attitudes and mailed to 400 randomly selected physicians. Results: A total of 155 (43.8%) of the 354 delivered surveys were returned. Physicians across all groups provided consistent responses suggesting a negative attitude about scheduling, a lack of understanding of scheduling issues and a harmful impact of scheduling on their practice. Physicians who saw 20 or more patients differed significantly from the other groups in 50% (4 of the 8) questions suggesting enhanced dissatisfaction.
{"title":"Physicians’ knowledge and attitudes toward scheduling","authors":"Jonathon M Parker, E. Larrat","doi":"10.1080/10601330902852725","DOIUrl":"https://doi.org/10.1080/10601330902852725","url":null,"abstract":"Objective: To determine physicians’ knowledge and attitudes of medico-legal issues regarding drug scheduling. Methods: The cross sectional survey was designed to assess attitudes and mailed to 400 randomly selected physicians. Results: A total of 155 (43.8%) of the 354 delivered surveys were returned. Physicians across all groups provided consistent responses suggesting a negative attitude about scheduling, a lack of understanding of scheduling issues and a harmful impact of scheduling on their practice. Physicians who saw 20 or more patients differed significantly from the other groups in 50% (4 of the 8) questions suggesting enhanced dissatisfaction.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"70 1","pages":"1 - 7"},"PeriodicalIF":0.0,"publicationDate":"2009-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81578845","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 : 2009-01-01DOI: 10.1080/10601330903200684
Ravi S Talluri, Ripal Gaudana, Sudharshan Hariharan, Ritesh Jain, Ashim K Mitra
The objective of this work was to study the disposition kinetics of valine-valine-acyclovir (VVACV), a dipeptide ester prodrug of acyclovir following intravenous and oral administrations in rat. A validated LC-MS/MS analytical method was developed for the analysis VVACV, Valine-Acyclovir (VACV), and Acyclovir (ACV) using a linear Ion Trap Quadrupole. ACV was administered orally for comparison purpose. In the VVACV group, both blood and urine samples and in the ACV group only blood samples were collected. All the samples were analyzed using LC-MS/MS. The LLOQ for ACV, VACV, and VVACV were 10, 10, and 50 ng/ml, respectively. Relevant pharmacokinetic parameters were obtained by non-compartmental analyses of data with WinNonlin. Following i.v. administration of VVACV, AUC(0-inf) (min*µM) values for VVACV, VACV, and ACV were 55.06, 106, and 466.96, respectively. The AUC obtained after oral administration of ACV was 178.8. However, following oral administration of VVACV, AUC(0-inf) values for VACV and ACV were 89.28 and 810.77, respectively. Thus the exposure of ACV obtained following oral administration of VVACV was almost 6-fold higher than ACV. This preclinical pharmacokinetic data revealed that VVACV has certainly improved the oral bioavailability of ACV and is an effective prodrug for oral delivery of ACV.
{"title":"Disposition kinetics of a dipeptide ester prodrug of acyclovir and its metabolites following intravenous and oral administrations in rat.","authors":"Ravi S Talluri, Ripal Gaudana, Sudharshan Hariharan, Ritesh Jain, Ashim K Mitra","doi":"10.1080/10601330903200684","DOIUrl":"https://doi.org/10.1080/10601330903200684","url":null,"abstract":"<p><p>The objective of this work was to study the disposition kinetics of valine-valine-acyclovir (VVACV), a dipeptide ester prodrug of acyclovir following intravenous and oral administrations in rat. A validated LC-MS/MS analytical method was developed for the analysis VVACV, Valine-Acyclovir (VACV), and Acyclovir (ACV) using a linear Ion Trap Quadrupole. ACV was administered orally for comparison purpose. In the VVACV group, both blood and urine samples and in the ACV group only blood samples were collected. All the samples were analyzed using LC-MS/MS. The LLOQ for ACV, VACV, and VVACV were 10, 10, and 50 ng/ml, respectively. Relevant pharmacokinetic parameters were obtained by non-compartmental analyses of data with WinNonlin. Following i.v. administration of VVACV, AUC(0-inf) (min*µM) values for VVACV, VACV, and ACV were 55.06, 106, and 466.96, respectively. The AUC obtained after oral administration of ACV was 178.8. However, following oral administration of VVACV, AUC(0-inf) values for VACV and ACV were 89.28 and 810.77, respectively. Thus the exposure of ACV obtained following oral administration of VVACV was almost 6-fold higher than ACV. This preclinical pharmacokinetic data revealed that VVACV has certainly improved the oral bioavailability of ACV and is an effective prodrug for oral delivery of ACV.</p>","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"26 3","pages":"65-72"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/10601330903200684","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29634920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2008-01-01DOI: 10.1080/10601330801937544
Ashok R. Chandak, P. Verma
The present study was aimed to develop Eudragit-based matrix system for transdermal delivery of methotrexate, an immunosuppressant drug for rheumatoid arthritis. Drug release followed zero order rather than first order or Higuchi type release kinetics. FT-IR, DSC and X-RD studies indicated no interaction between drug and polymer. The in-vitro dissolution rate constant, dissolution half life, and pharmacokinetic parameters (Cmax, tmax, AUC(s), t1/2, Kel, and MRT) were evaluated statistically by two-way ANOVA. A significant difference was observed between test products but not within test products. Statistically, a good correlation was found between percent of drug absorbed from patches versus Cmax, and AUC(s). Percent of drug dissolved at a given time versus serum drug concentration was correlated statistically. The results of this study indicate that the polymeric matrix films of methotrexate hold potential for transdermal.
{"title":"Transdermal Delivery of Methotrexate Using Mixed Grades of Eudragit: Physico-Chemical, In-Vitro, and In-Vivo Evaluations","authors":"Ashok R. Chandak, P. Verma","doi":"10.1080/10601330801937544","DOIUrl":"https://doi.org/10.1080/10601330801937544","url":null,"abstract":"The present study was aimed to develop Eudragit-based matrix system for transdermal delivery of methotrexate, an immunosuppressant drug for rheumatoid arthritis. Drug release followed zero order rather than first order or Higuchi type release kinetics. FT-IR, DSC and X-RD studies indicated no interaction between drug and polymer. The in-vitro dissolution rate constant, dissolution half life, and pharmacokinetic parameters (Cmax, tmax, AUC(s), t1/2, Kel, and MRT) were evaluated statistically by two-way ANOVA. A significant difference was observed between test products but not within test products. Statistically, a good correlation was found between percent of drug absorbed from patches versus Cmax, and AUC(s). Percent of drug dissolved at a given time versus serum drug concentration was correlated statistically. The results of this study indicate that the polymeric matrix films of methotrexate hold potential for transdermal.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"14 1","pages":"53 - 72"},"PeriodicalIF":0.0,"publicationDate":"2008-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74347629","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 : 2008-01-01DOI: 10.1080/10601330802208291
M. Varney, Rakesh K. Singh
Current evidence suggests an increasing role for inflammation as a critical link to tumor progression. The host response to a cancer shares many parallels with an infection or a wound. Thus it is not surprising that many tumors arise from areas of infection or chronic inflammation. Tumors have been described as wounds that never heal. The local production of cytokines, including chemokines not only attracts circulating immune cells, but also activates stromal cells in the surrounding microenvironment. Of particular interest are tumor-associated macrophages (TAM). The infiltration of tumors with TAM has been shown to correlate with poor prognosis in several cancers. Recent studies suggest an emerging role for TAM in the remodeling of the tumor microenvironment to support growth and metastasis and support the concept of modifying TAM's responses as novel therapeutic approaches. In this review, we will discuss our current understanding of the role of macrophages, and inflammation in the progression to malignant disease and possibilities for development of better therapeutics for the treatment and perhaps prevention of malignancies.
{"title":"The Role of Inflammation in Tumor Progression: Targeting Tumor-Associated Macrophages","authors":"M. Varney, Rakesh K. Singh","doi":"10.1080/10601330802208291","DOIUrl":"https://doi.org/10.1080/10601330802208291","url":null,"abstract":"Current evidence suggests an increasing role for inflammation as a critical link to tumor progression. The host response to a cancer shares many parallels with an infection or a wound. Thus it is not surprising that many tumors arise from areas of infection or chronic inflammation. Tumors have been described as wounds that never heal. The local production of cytokines, including chemokines not only attracts circulating immune cells, but also activates stromal cells in the surrounding microenvironment. Of particular interest are tumor-associated macrophages (TAM). The infiltration of tumors with TAM has been shown to correlate with poor prognosis in several cancers. Recent studies suggest an emerging role for TAM in the remodeling of the tumor microenvironment to support growth and metastasis and support the concept of modifying TAM's responses as novel therapeutic approaches. In this review, we will discuss our current understanding of the role of macrophages, and inflammation in the progression to malignant disease and possibilities for development of better therapeutics for the treatment and perhaps prevention of malignancies.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"20 1","pages":"139 - 155"},"PeriodicalIF":0.0,"publicationDate":"2008-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81187010","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 : 2008-01-01DOI: 10.1080/10601330802383441
Butchi Raju Akondi, R. Chodavarapu, K. Devarakonda
The aim of this study was to describe population pharmacokinetics of amikacin in Indian pediatric population. Dosage adjustment based on individual pharmacokinetic parameters is of considerable importance for effective and safe use of drugs. Extensive work on amikacin and other aminoglycosides was carried out in different pediatric patient populations but no data are available in Indian pediatric patients. In the present study 74 steady state concentrations of amikacin were analyzed from 42 patients. Pharmacostatistical work was done by using NONMEM. The covariates evaluated in this study were age, body weight, height, and sex and creatinine clearance. The model found to best describe the data following FO method was: Clearance (CL) = θ1*(wt/14.2)*exp. (η1) and volume (V) = θ2*exp (η2) and following FOCE method was: Clearance (CL) = θ1*(age/5.38) + θ3*(wt/14.2)*exp.(η1) and volume(V) = θ2*exp(η2). The final model estimates of CL and V estimated by FO method were1.02 L/h and 4.55L respectively and by FOCE method were1.07L/hr and 4.91L respectively. These parameters are utilized for individualizing the loading and maintenance doses in pediatric patients.
{"title":"Population Pharmacokinetics of Amikacin in Indian Pediatric Patients","authors":"Butchi Raju Akondi, R. Chodavarapu, K. Devarakonda","doi":"10.1080/10601330802383441","DOIUrl":"https://doi.org/10.1080/10601330802383441","url":null,"abstract":"The aim of this study was to describe population pharmacokinetics of amikacin in Indian pediatric population. Dosage adjustment based on individual pharmacokinetic parameters is of considerable importance for effective and safe use of drugs. Extensive work on amikacin and other aminoglycosides was carried out in different pediatric patient populations but no data are available in Indian pediatric patients. In the present study 74 steady state concentrations of amikacin were analyzed from 42 patients. Pharmacostatistical work was done by using NONMEM. The covariates evaluated in this study were age, body weight, height, and sex and creatinine clearance. The model found to best describe the data following FO method was: Clearance (CL) = θ1*(wt/14.2)*exp. (η1) and volume (V) = θ2*exp (η2) and following FOCE method was: Clearance (CL) = θ1*(age/5.38) + θ3*(wt/14.2)*exp.(η1) and volume(V) = θ2*exp(η2). The final model estimates of CL and V estimated by FO method were1.02 L/h and 4.55L respectively and by FOCE method were1.07L/hr and 4.91L respectively. These parameters are utilized for individualizing the loading and maintenance doses in pediatric patients.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"3 1","pages":"173 - 182"},"PeriodicalIF":0.0,"publicationDate":"2008-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90063149","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 : 2008-01-01DOI: 10.1080/10601330701885116
K. Vanaja, R. H. Shobha Rani, S. Sacchidananda
Ultradeformable liposomes of Methotrexate (MTX) were formulated to enhance its transdermal delivery in the treatment of psoriasis. Formulations were characterized for particle size, polydispersity index, morphology employing TEM and residual solvent analysis. The efficacy of topical liposomal MTX gel was compared with the commercially available plain MTX gel by clinically investigating the reduction in PASI score in psoriasis patients. Allergic contact sensitization potential of placebo ultradeformable liposomal gel was evaluated which showed that the placebo gel did not produce any reaction in the induction as well as challenge phase in 12 human volunteers. Open label, randomized parallel study was conducted in 25 patients. Baseline PASI score in the group receiving liposomal gel (0.25%) was 5.3 ± 1.027 and at the 10th week was reduced to 2.4 ± 0.625. In the case of the group applying plain MTX gel (1%), the baseline PASI score was 6.2 ± 0.17, reduced to 2.9 ± 0.79 at the 10th week. It was observed that liposomal MTX gel of 0.25% improved palmoplantar psoriasis in comparison with 1% plain MTX gel. Therefore, reducing the dose by entrapping MTX in liposomes improved the efficacy and patient compliance.
{"title":"Formulation and Clinical Evaluation Of Ultradeformable Liposomes in the Topical Treatment of Psoriasis","authors":"K. Vanaja, R. H. Shobha Rani, S. Sacchidananda","doi":"10.1080/10601330701885116","DOIUrl":"https://doi.org/10.1080/10601330701885116","url":null,"abstract":"Ultradeformable liposomes of Methotrexate (MTX) were formulated to enhance its transdermal delivery in the treatment of psoriasis. Formulations were characterized for particle size, polydispersity index, morphology employing TEM and residual solvent analysis. The efficacy of topical liposomal MTX gel was compared with the commercially available plain MTX gel by clinically investigating the reduction in PASI score in psoriasis patients. Allergic contact sensitization potential of placebo ultradeformable liposomal gel was evaluated which showed that the placebo gel did not produce any reaction in the induction as well as challenge phase in 12 human volunteers. Open label, randomized parallel study was conducted in 25 patients. Baseline PASI score in the group receiving liposomal gel (0.25%) was 5.3 ± 1.027 and at the 10th week was reduced to 2.4 ± 0.625. In the case of the group applying plain MTX gel (1%), the baseline PASI score was 6.2 ± 0.17, reduced to 2.9 ± 0.79 at the 10th week. It was observed that liposomal MTX gel of 0.25% improved palmoplantar psoriasis in comparison with 1% plain MTX gel. Therefore, reducing the dose by entrapping MTX in liposomes improved the efficacy and patient compliance.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"118 1","pages":"41 - 52"},"PeriodicalIF":0.0,"publicationDate":"2008-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85702265","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 : 2008-01-01DOI: 10.1080/10601330802131451
L. Endrenyi, L. Tothfalusi
There is no abstract
没有抽象
{"title":"Evaluation of Bioequivalence of Highly Variable Drugs","authors":"L. Endrenyi, L. Tothfalusi","doi":"10.1080/10601330802131451","DOIUrl":"https://doi.org/10.1080/10601330802131451","url":null,"abstract":"There is no abstract","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"6 1","pages":"117 - 93"},"PeriodicalIF":0.0,"publicationDate":"2008-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84151851","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 : 2008-01-01DOI: 10.1080/10601330802064272
A. Khuroo, T. Monif, P. Verma, S. Gurule
The objective of this crossover bioavailability study on amoxicillin was to compare the bioavailability under fasting and five different diets, in twelve healthy adult male human volunteers. A single dose of amoxicillin 500 mg capsule was administered at six occasions: after overnight fasting, after two vegetarian diets (high-fat and low-fat), two non-vegetarian diets (high-fat and low-fat) and milk. Serial blood samples were collected up to 8 h after dose. Plasma concentrations were determined using a validated LC-MS/MS method. Tmax increased and AUC and Cmax values decreased in the presence of food. The non-vegetarian diets affected the rate of absorption of amoxicillin more than the vegetarian diets.
{"title":"Comparison of Effect of Fasting and of Five Different Diets on the Bioavailability of Single Oral Dose of Amoxicillin 500 mg Capsule","authors":"A. Khuroo, T. Monif, P. Verma, S. Gurule","doi":"10.1080/10601330802064272","DOIUrl":"https://doi.org/10.1080/10601330802064272","url":null,"abstract":"The objective of this crossover bioavailability study on amoxicillin was to compare the bioavailability under fasting and five different diets, in twelve healthy adult male human volunteers. A single dose of amoxicillin 500 mg capsule was administered at six occasions: after overnight fasting, after two vegetarian diets (high-fat and low-fat), two non-vegetarian diets (high-fat and low-fat) and milk. Serial blood samples were collected up to 8 h after dose. Plasma concentrations were determined using a validated LC-MS/MS method. Tmax increased and AUC and Cmax values decreased in the presence of food. The non-vegetarian diets affected the rate of absorption of amoxicillin more than the vegetarian diets.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"1 1","pages":"73 - 86"},"PeriodicalIF":0.0,"publicationDate":"2008-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89512303","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：