Generic Drug Product Development

Describes the development of solid oral generic drug products from project initiation to market approval - collecting discussions from more than 30 noted specialists on topics such as quality control and quality assurance, experimental formulation, pharmaceutical ingredients, drug delivery, and bioequivalence.

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Keeping pace with the latest technologies in the field, this guide describes the development of solid oral generic drug products from project initiation to market approval. Focusing on immediate-release and modified-release dosage forms, the book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulation, pharmaceutical ingredients, and bioequivalence, and considers key elements in the formulation of generic drug products including the availability of raw materials, chemical purity. It also highlights constraints in generic drug development that differ from the formulation design of a brand name pharmaceutical product.