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

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Bransford, PhilipVertex Pharmaceut Inc, 50 Northern Ave, Boston, MA 02210 USA (författare)

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

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.

Cook, JackPfizer Inc, Global Prod Dev, Clin Pharmacol Dept, Groton, CT 06320 USA (författare)
Gupta, ManishGlaxoSmithKline, Biopharmaceut Prod Dev & Supply, Collegeville, PA 19426 USA (författare)
Haertter, SebastianBoehringer Ingelheim Pharmaceut Inc, Ridgefield, CT 06877 USA (författare)
He, HandanNovartis Inst Biomed Res, Dept Drug Metab & Pharmacokinet, E Hanover, NJ 07936 USA (författare)
Ju, RobAbbVie, Drug Prod Dev, N Chicago, IL 60064 USA (författare)
Kanodia, JitendraTheravance Biopharma US Inc, San Francisco, CA 94080 USA (författare)
Lennernäs, HansUppsala universitet,Institutionen för farmaci(Swepub:uu)hanslenn (författare)
Lindley, DavidAbbVie Inc, N Chicago, IL 60064 USA (författare)
Polli, James E.Univ Maryland, Dept Pharmaceut Sci, Baltimore, MD 21201 USA (författare)
Wenning, LarissaMerck & Co Inc, MRL, Pharmacokinet Pharmacodynam & Drug Metab, West Point, PA 19486 USA (författare)
Wu, YunhuiMerck & Co Inc, MRL, Pharmaceut Sci, West Point, PA 19486 USA (författare)
Vertex Pharmaceut Inc, 50 Northern Ave, Boston, MA 02210 USAPfizer Inc, Global Prod Dev, Clin Pharmacol Dept, Groton, CT 06320 USA (creator_code:org_t)

Ingår i:Molecular Pharmaceutics: AMER CHEMICAL SOC17:2, s. 361-3721543-83841543-8392

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