




Stability Testing of Pharmaceutical Products
ABSTRACT
Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any pharmaceutical product. These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO and or other agencies. Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to stability of pharmaceutical products have been presented in a concise manner in the present review
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09-30-14-Presentation-Stability-Testing-Seminar-FDA-News-Virtual-Conference-September-30-2014
USP Overview and Some Current Activities
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Anthony DeStefano, Ph.D. Senior Vice President, Compendial Science, USP
Aseptic Processing of Biological Products: Current Regulatory Issues “Facing the Challenges of Drug Product Manufacturing”
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“Facing the Challenges of Drug Product and Device Development & Manufacturing”
Patricia F. Hughes, Ph.D. Branch Chief (Acting) FDA/CDER/OPQ/OPF/DMA/BIV
WCPB 2016 January 27, 2016 Washington, D.C.
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