November 18, - P.5 Control of Drug Product P Specification(s). The International Federation of Pharmaceutical Manufacturers and Associations is the voice of the innovative pharmaceutical industry, collaborating for global health progress to improve lives everywhere. March 19, - The European Medicines Agency is a decentralised agency of the European Union responsible for the evaluation, supervision and safety monitoring of medicines. December 22, - This document is intended to provide guidance with regard to the Quality [that is (i.e.), Chemistry and Manufacturing] portion of NDSs and ANDSs for drug substances of synthetic or semi-synthetic origin and their corresponding drug products that are filed with Health Canada pursuant to Division. June 23, - This full Series follows our initial Primer blogs: Constructing the CTD Quality Module 3, and Quality Overall Summary: Reviewers Guide. June 9, - We cannot provide a description for this page right now. Search and explore the millions of quality, peer-reviewed journal articles published under the Taylor & Francis, Routledge and Dove Medical Press imprints. March 1, - An introduction to the Quality (Chemistry, Manufacturing, and Controls) section of eCTD - this blog describes the Module 2 and 3 components that relate to Quality. The aim of the study was to investigate the common deficiencies observed in the Finished Pharmaceutical Product (FPP) section of generic product applications submitted to SAHPRA. The study was conducted retrospectively over a 7-year period. The University of Michigan Center for RNA Biomedicine brings together RNA scientists, whose passion and research are at the frontier of RNA discoveries. 9th Annual RNA Symposium, March , Presented.
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