An IPRP survey of the regulatory requirements for the waiver of in vivo bioequivalence studies of generic medicinal products in certain dosage forms

IF 0.3 Q4 PHARMACOLOGY & PHARMACY

GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2021-09-15 DOI:10.5639/gabij.2021.1003.019

A. Garcia Arieta, Clare Rodrigues

引用次数: 0

Abstract

Medicines regulatory authorities aim to address rising healthcare costs and promote access to medicines worldwide through review and approval of quality generic drug products that are interchangeable with the corresponding reference medicinal product.

查看原文本刊更多论文

IPRP对某些剂型的非专利药品放弃体内生物等效性研究的监管要求的调查

药品监管机构的目标是通过审查和批准可与相应参考药品互换的高质量非专利药品，解决不断上升的医疗成本问题，并促进全世界药品的可及性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

GaBI Journal-Generics and Biosimilars Initiative Journal PHARMACOLOGY & PHARMACY-

CiteScore

1.80

自引率

0.00%

发文量

期刊介绍： The scope of GaBI Journal is broad and of interest and relevance to professionals active in clinical practice, pharmaceutical science and policy. Materials published in GaBI Journal include high quality research reports, literature reviews and case studies, all of which are peer reviewed. Manuscripts on all aspects of generic and biosimilar medicines, covering areas in clinical, fundamental, technical, manufacturing, bi-processing, economic and social aspects of pharmaceuticals and therapeutics are welcome. In addition, high quality work submitted in other formats, for example, scientific and evidence-based commentaries, may also be considered. In all cases, the emphasis is on quality, originality and knowledge contribution to those involved in health care. All manuscripts submitted to GaBI Journal are subject to a rigorous peer review process. GaBI Journal plans to be indexed in PubMed within two years, and that indexing will be retrospective. GaBI Journal is published quarterly from 2012. All articles are published in English.