Part 1: A Review and Perspective of the Regulatory Guidance to Support Designation and Justification of API Starting Material

Autor:	Steven Pfeiffer, John D. Orr, Maciej Smulkowski, Carl A. Busacca, Fred Hicks, William F. Kiesman, Margaret M. Faul, Magnus C. Eriksson
Rok vydání:	2014
Předmět:	Knowledge management Process (engineering) business.industry media_common.quotation_subject Interpretation (philosophy) Organic Chemistry Perspective (graphical) Quality (business) Context (language use) Business Physical and Theoretical Chemistry Commercialization media_common
Zdroj:	Organic Process Research & Development. 18:587-593
ISSN:	1520-586X 1083-6160
Popis:	Designation and justification of active pharmaceutical ingredient starting material (API SM) is a standard part of the drug substance (DS) development and commercialization process. However, current industry practices are not well understood and vary, depending on the individual company’s interpretation of regulatory guidelines. In addition, regulators are also applying varying interpretations to the designation of API SMs, further complicating progress in this arena. To increase the understanding of the strategies employed in selection and justification of API SMs the authors, members of the API and Analytical Leadership Groups of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), completed a broad industry survey of this topic among the 35 IQ Consortium member companies. To put the results of this survey into context, an understanding of the historical development of API SM regulations and the industry perspective is important and is summarized collectively for t...
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::1355b3d28d0a557d2664084e6c5cc122 https://doi.org/10.1021/op500059k Zobrazit plný text záznamu