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Handbook of Pharmaceutical Manufacturing Formulations, Second Edition: (Six-Volume Set)

An authoritative and practical guide to the art and science of formulating drugs.

With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug Applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues concerning drug manufacturing.

A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this set is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.

As the largest reference on pharmaceutical formulations, this handbook also provides guidelines on how to file aNDAs in the shortest possible time, helping pharmaceutical companies to cut costs in the areas of pharmaceutical research and development.

Divided conveniently into two parts—regulatory and manufacturing guidelines, and formulations—each volume in the set covers:

  • cGMP compliance
  • pre-approval inspections
  • stability and bioequivalence testing
  • packaging commodity development
  • common difficulties in formulating drugs
  • changes to aNDAs


  1. u r making a gr8 efforts , but can you upload them on another website except rapidshare like ifile or megaupload????? plz =/..

    thank u again

  2. Awesome! Thanks for your contribution to the academic pharma community.

  3. Hi!!! Can you post the other volumes??? There is only one (volume 1).

    This is a great handbook!!!

    Thanks a lot for your commitment to post the newer references...

  4. Thanks a lot this a great book ... but the best website is MEDIAFIRE (so fast and you dont have to wait fifteen minutes for start another download)... do you have some book related to Acceptance Sampling in Quality Control? Greetings from Peru.