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1. A Perspective on Quality by Design: A Preclinical Opportunity

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   Document | 28 Mar 2024 | Contributor(s):: Ajaz S. Hussain

2. 

   VENKATREDDY SUNKARA

   Senior Regulatory Affairs Director with a demonstrated history of 18 years experience in Biologics/Pharmaceuticals (API & Drug Product) products registration with Global regulatory authorities...

   https://cmkc.usp.org/members/1476

3. Recent Advances in Co-processed APIs and Proposals for Enabling Commercialization of These Transformative Technologies

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   Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Schenck, L, Erdemir, DGorka, LS, Merritt, JM, Marziano, I, Ho, R, Lee, M, Bullard, J, Boukerche, M, Ferguson, S, Florence, AJ, Khan, SA, Sun, CC

   Optimized physical properties (e.g., bulk, surface/interfacial, and mechanical properties) of active pharmaceutical ingredients (APIs) are key to the successful integration of drug substance and drug product manufacturing, robust drug product manufacturing operations, and ultimately to attaining...

4. Part 3: Enhanced Approaches to the Development of the Control Strategy and its Implementation in the Manufacturing Process Description

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   Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Popkin, ME, Omer, BASeibert, KD, Luciani, CV, Srivastava, S, Hobson, L, Lepore, JV

   A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced Quality by Design (QbD) development of the active pharmaceutical ingredient (API) can lead to differentiated outcomes for elements such as the API...