ICH M9 Guideline in Development on Biopharmaceutics Classification System-Based Biowaivers: An Industrial Perspective from the IQ Consortium.,Molecular Pharmaceutics

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ICH M9 Guideline in Development on Biopharmaceutics Classification System-Based Biowaivers: An Industrial Perspective from the IQ Consortium.
Molecular Pharmaceutics ( IF 4.5 ) Pub Date : 2020-01-07 , DOI: 10.1021/acs.molpharmaceut.9b01062
Philip Bransford ₁ , Jack Cook ₂ , Manish Gupta ₃ , Sebastian Haertter ₄ , Handan He ₅ , Rob Ju ₆ , Jitendra Kanodia ₇ , Hans Lennernäs ₈ , David Lindley ₉ , James E Polli ₁₀ , Larissa Wenning ₁₁ , Yunhui Wu ₁₂

Affiliation

Vertex Pharmaceuticals Incorporated , 50 Northern Avenue , Boston , Massachusetts 02210 , United States.
Clinical Pharmacology Department, Global Product Development , Pfizer, Inc. , Groton , Connecticut 06320 , United States.
Biopharmaceutics, Product Development and Supply , GlaxoSmithKline , Collegeville , Pennsylvania 19426 , United States.
Boehringer Ingelheim Pharmaceuticals, Inc. , Ridgefield , Connecticut 06877 , United States.
Department of Drug Metabolism and Pharmacokinetics , Novartis Institutes for Biomedical Research , East Hanover , New Jersey 07936 , United States.
Drug Product Development , Abbvie , North Chicago , Illinois 60064 , United States.
Theravance Biopharma US, Inc. , South San Francisco , California 94080 , United States.
Department of Pharmacy , Uppsala University , Box 580, 751 23 Uppsala , Sweden.
AbbVie Inc. , North Chicago , Illinois 60064 , United States.
Department of Pharmaceutical Sciences , University of Maryland , Baltimore , Maryland 21201 , United States.
Pharmacokinetics, Pharmacodynamics and Drug Metabolism, MRL , Merck & Co., Inc. , West Point , Pennsylvania 19486 , United States.
Pharmaceutical Sciences, MRL , Merck & Co., Inc. , West Point , Pennsylvania 19486 , United States.

In October 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) ICH began efforts to provide recommendations to harmonize guidances for biopharmaceutics classification system (BCS)-based biowaivers. Topics to be addressed included consideration of the dose used to classify solubility, tests, and criteria for establishing highly permeable, dissolution conditions, the influence of excipients, and aspects of product strength. The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) is a technically focused organization of pharmaceutical and biotechnology companies with a mission of advancing science and technology to augment the capability of member companies to develop transformational solutions that benefit patients, regulators, and the broader R&D community. Its members have substantial expertise in all scientific domains associated with BCS-based waivers and drug product quality, as well as considerable experience in the application of BCS-based biowaivers. The ICH process recognizes that harmonization is achieved through the development of guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side. Thus, to facilitate these efforts and to encourage open and transparent discussion of other perspectives that may exist, IQ offers their perspective on these and related topics.

中文翻译：

ICH M9基于生物制药分类系统的生物豁免开发指南：IQ联盟的工业视角。

2016年10月，国际人用药品技术要求统一理事会（ICH）ICH开始努力提供建议，以协调基于生物药品分类系统（BCS）的生物豁免指南。要解决的主题包括考虑用于溶解度分类的剂量，测试和建立高渗透性，溶解条件的标准，赋形剂的影响以及产品强度的方面。国际药物开发创新与质量联盟（IQ）是一家以制药和生物技术公司为技术重点的组织，其使命是推进科学技术，以增强成员公司开发有益于患者，监管机构和医务人员的转型解决方案的能力。更广泛的R＆D社区。其成员在与基于BCS的豁免和药品质量相关的所有科学领域均具有丰富的专业知识，并且在基于BCS的生物豁免的应用方面具有丰富的经验。ICH流程认识到，通过与监管机构和行业专家并肩工作的科学共识，通过制定准则来实现协调。因此，为了促进这些努力并鼓励对可能存在的其他观点进行公开透明的讨论，IQ就这些以及相关主题提供了他们的观点。ICH流程认识到，通过与监管机构和行业专家并肩工作的科学共识，通过制定准则来实现协调一致。因此，为了促进这些努力并鼓励对可能存在的其他观点进行公开透明的讨论，IQ就这些以及相关主题提供了他们的观点。ICH流程认识到，通过与监管机构和行业专家并肩工作的科学共识，通过制定准则来实现协调一致。因此，为了促进这些努力并鼓励对可能存在的其他观点进行公开透明的讨论，IQ就这些以及相关主题提供了他们的观点。

更新日期：2020-01-08

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