Crane Christopher, Santos Gustavo Mendes Lima, Fernandes Eduardo Agostinho Freitas, Simon Craig, Tam Andrew, Triana Diego Gutierrez, Potthast Henrike, Kuribayashi Ryosuke, Okada Yusuke, Myoenzono Aya, Calderon Ivan Omar, Rodriguez Zulema, Jones Ben, Park Sang Aeh, Eum So Young, Rodrigues Clare, Van Oudsthoorn Joy, Nolting Arno, Walther Chantal, Roost Matthias S, Hung Wen-Yi, Braddy April C, Garcia-Arieta Alfredo
Therapeutic Goods Administration.
J Pharm Pharm Sci. 2019;22(1):486-500. doi: 10.18433/jpps30724.
In relation to the registration of generic products, waivers of in vivo bioequivalence studies (biowaivers) are considered in three main cases: certain dosage forms for which bioequivalence is self-evident (e.g. intravenous solutions), biowaivers based on the Biopharmaceutics Classification System and biowaivers for additional strengths with respect to the strength for which in vivo bioequivalence has been shown. The objective of this article is to describe the differences and commonalities in biowaivers for additional strengths of immediate release solid oral dosage forms between the participating members of the International Pharmaceutical Regulators Program (IPRP). The requirements are based on five main aspects; the pharmacokinetics of the drug substance, the manufacturing process, the qualitative and quantitative composition of the different strengths, and the comparative dissolution profiles. For the pharmacokinetic aspects, many regulators/agencies have the same requirements. All strengths must be manufactured with the same process, although a few regulators/agencies accept small differences. In relation to the formulation aspects, the data required breaks down into three major approaches based initially on one of those of the EU, the USA or Japan, but there are some differences in these three major approaches with some country specific interpretations. Most regulators/agencies also have the same requirements for the dissolution data, though there are some notable exceptions.
关于仿制药的注册，在三种主要情况下可考虑豁免体内生物等效性研究（生物豁免）：生物等效性不言而喻的某些剂型（如静脉注射液）、基于生物药剂学分类系统的生物豁免以及已证明具有体内生物等效性的规格之外其他规格的生物豁免。本文的目的是描述国际药品监管者计划（IPRP）参与成员之间关于速释固体口服剂型其他规格生物豁免的差异和共性。这些要求基于五个主要方面：原料药的药代动力学、生产工艺、不同规格的定性和定量组成以及比较溶出曲线。在药代动力学方面，许多监管机构有相同的要求。所有规格必须采用相同工艺生产，不过有少数监管机构接受细微差异。在制剂方面，所需数据最初基于欧盟、美国或日本的方法之一分为三种主要方法，但这三种主要方法存在一些差异，还有一些国家特定的解释。大多数监管机构对溶出数据也有相同要求，不过也有一些明显的例外情况。
