LIFECYCLE MANAGEMENT OF PHARMACEUTICAL PRODUCTS
Explores the process of bringing pharmaceutical products to market, particularly as it applies to the scaling up, manufacturing, and maintenance phases that come after FDA approval of a product is obtained. Identifies various factors that impact the life cycle management of pharmaceutical products from development to sustained large-scale distribution, such as: target product profile (TPP), chemistry, manufacturing and controls (CMC), active pharmaceutical ingredient (API) supply chain considerations, raw materials shortages, demand planning/forecasting, and post-approval regulatory considerations.
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