小儿眼科中的商业制剂与复方制剂。

IF 3.4 3区 医学 Q1 PEDIATRICS Pediatric Drugs Pub Date : 2024-09-01 Epub Date: 2024-06-27 DOI:10.1007/s40272-024-00642-w
Annegret Dahlmann-Noor, Jill Bloom, Saw Keng Lee, Samiya Chowdhury, Kanwal Nischal, Dominique Bremond-Gignac
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引用次数: 0

摘要

儿科眼科医生负责治疗的许多疾病都是罕见病,即使有药物治疗方法,也往往没有在儿童中进行过评估。标签外处方是儿科眼科的常见做法。此外,生产一种可能只用于全球少数患者的药物往往没有商业价值。因此,当地配制的复方制剂仍在频繁使用,尽管众所周知,生产过程可能无法达到严格的质量保证标准。对于一些适应症,经过严格的儿童临床试验评估的商业制剂现已上市。澳大利亚、美国和欧洲最近进行的临床试验得出的低浓度阿托品制剂现已进入市场。这篇短文概述了用于儿童眼科的复方制剂和商业制剂的背景和最新发展。
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Commercial Versus Compounded Preparations in Pediatric Ophthalmology.

Many conditions managed by pediatric ophthalmologists are rare diseases, and even if pharmacological treatments are available, these have often not been evaluated in children. Off-label prescribing is a common practice in pediatric ophthalmology. In addition, there is often no commercial case for the production of a medicine that may only be used for a small number of patients worldwide. Compounded preparations prepared locally are therefore still in frequent use, although it is known that production may not meet stringent quality assurance standards. For several indications, commercial preparations, evaluated in rigorous clinical trials with children, are now available. Myopia management is joining the list of these indications, with low-concentration atropine formulations derived from recent clinical trials in Australia, USA, and Europe now entering the market. This short article gives an overview of the background and recent developments of compounded and commercial preparations for use in pediatric ophthalmology.

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来源期刊
Pediatric Drugs
Pediatric Drugs PEDIATRICS-PHARMACOLOGY & PHARMACY
CiteScore
7.20
自引率
0.00%
发文量
54
审稿时长
>12 weeks
期刊介绍: Pediatric Drugs promotes the optimization and advancement of all aspects of pharmacotherapy for healthcare professionals interested in pediatric drug therapy (including vaccines). The program of review and original research articles provides healthcare decision makers with clinically applicable knowledge on issues relevant to drug therapy in all areas of neonatology and the care of children and adolescents. The Journal includes: -overviews of contentious or emerging issues. -comprehensive narrative reviews of topics relating to the effective and safe management of drug therapy through all stages of pediatric development. -practical reviews covering optimum drug management of specific clinical situations. -systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. -Adis Drug Reviews of the properties and place in therapy of both newer and established drugs in the pediatric population. -original research articles reporting the results of well-designed studies with a strong link to clinical practice, such as clinical pharmacodynamic and pharmacokinetic studies, clinical trials, meta-analyses, outcomes research, and pharmacoeconomic and pharmacoepidemiological studies. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pediatric Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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