Generic Drug Product Development: Solid Oral Dosage Forms (Drugs and the Pharmaceutical Sciences) - Hardcover

9780824754600: Generic Drug Product Development: Solid Oral Dosage Forms (Drugs and the Pharmaceutical Sciences)

Hardcover

ISBN 10: 0824754603 ISBN 13: 9780824754600

Publisher: CRC Press, 2004

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.

"synopsis" may belong to another edition of this title.

Review

"interesting and varied reading.well written and edited. There is a good blend of authors from academia, the pharmaceutical industry, and the FDA. "useful for those working, or having an interest in generic pharmaceutical manufacture and regulation." -International Journal of Pharmaceutics

Synopsis

Responds to the increasing worldwide demand for new generic drug products. 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 - collecting in-depth discussions from more than 30 noted specialists on topics such as quality control and quality assurance, experimental formulation, pharmaceutical ingredients, drug delivery, and bioequivalence.

"About this title" may belong to another edition of this title.