Shargel Generic Drug Product Development

Solid Oral Dosage Forms
Erscheinungsjahr 2004
ISBN: 978-1-4200-3041-9
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 408 Seiten

Reihe: Drugs and the Pharmaceutical Sciences

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.

Zielgruppe

Pharmacists; pharmacologists; clinical investigators; pharmaceutical industry professionals involved in clinical, regulatory, statistical, and legal development of generic drugs; and graduate and upper-level undergraduate students who intend to pursue careers in the pharmaceutical industry

Autoren/Hrsg.

Shargel, Leon

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie