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

Pub Date : 2021-09-15 DOI:10.5639/gabij.2021.1003.019
A. Garcia Arieta, Clare Rodrigues
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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.
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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。
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