Autor: SARFARAZ K. NIAZI
Editora: INFORMA HEALTHCARE

Resenha:
Revised and expanded, this new six-volume set compiles volumes from FDA New Drug Applications, patent applications, and sources of generic and proprietary formulations to cover issues concerning drug manufacturing. A must-have for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this set is the platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. The largest reference on pharmaceutical formulations, this text provides guidelines on filing aNDAs efficiently, helping pharmaceutical companies to cut costs in research and development. Each volume covers: ò cGMP compliance ò pre-approval inspections ò stability/bioequivalence testing ò packaging commodity development ò difficulties in formulating drugs ò aNDAs ò SUPAC for equipment ò accessible formulations as chemical entities, dosage forms, or pharmacological classifications.

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