Handbook of Pharmaceutical Manufacturing Formulations. Volume 6, Sterile Products
3rd edition

Par : Sarfaraz K. Niazi
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  • Nombre de pages416
  • PrésentationRelié
  • FormatGrand Format
  • Poids1.37 kg
  • Dimensions22,0 cm × 28,5 cm × 3,0 cm
  • ISBN978-1-138-10383-2
  • EAN9781138103832
  • Date de parution01/01/2020
  • ÉditeurEditeurs divers Royaume-Uni

Résumé

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition, Volume Six, Sterile Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this sixth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including the author's own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting.
A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features : Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions. Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing.
Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements. Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines.
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition, Volume Six, Sterile Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this sixth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including the author's own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting.
A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features : Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions. Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing.
Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements. Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines.