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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.
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Drugs and the Pharmaceutical Sciences - 143: Generic Drug Product Development, Leon Shargel, Isadore Kanfer
- Idioma
- Publicado en
- 2004
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- Título
- Drugs and the Pharmaceutical Sciences - 143: Generic Drug Product Development
- Subtítulo
- Solid Oral Dosage Forms
- Idioma
- Inglés
- Autores
- Leon Shargel, Isadore Kanfer
- Editorial
- CRC Press
- Publicado en
- 2004
- Formato
- Tapa dura
- Páginas
- 381
- ISBN10
- 0824754603
- ISBN13
- 9780824754600
- Serie
- Etiquetas
- EE.UU., Tecnología, Medicina, Medicamentos y fármacos
- Descripción
- 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.