[PDF] Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition (Drugs and the Pharmaceutical Sciences)

ISBN: 1420086359

Category: Tutorial


Posted on 2017-11-10, by luongquocchinh.

Description



Author: Leon Shargel, Isadore Kanfer | Category: Chemical Engineering | Language: English | Page: 397 | ISBN: 1420086359 | ISBN13: 9781420086355 |

Description: In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. Major topics discussed include: Active pharmaceutical ingredients Experimental formulation development, including a new section on Quality by Design (QbD) Scale-up Commercial product formulation Quality control and bioequivalence Drug product performance ANDA regulatory process Post-approval changes Post-marketing surveillance Legislative and patent challenges This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.

DOWNLOADDownload this book
Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition (Drugs and the Pharmaceutical Sciences).pdf
http://tezfiles.com/file/f450b6d1d3e18/1420086359.pdf

Sponsored High Speed Downloads
5613 dl's @ 3860 KB/s
Download Now [Full Version]
5320 dl's @ 2209 KB/s
Download Link 1 - Fast Download
8098 dl's @ 3029 KB/s
Download Mirror - Direct Download



Search More...
[PDF] Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition (Drugs and the Pharmaceutical Sciences)

Search free ebooks in ebookee.com!


Links
Download this book

No active download links here?
Please check the description for download links if any or do a search to find alternative books.


Related Books

  1. Ebooks list page : 33337
  2. 2019-05-10Generic Drug Product Development Solid Oral Dosage Forms, Second Edition
  3. 2013-10-21Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition
  4. 2018-01-17[PDF] Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Fourth Edition (Drugs and the Pharmaceutical Sciences)
  5. 2018-01-28[PDF] Ophthalmic Drug Delivery Systems, Second Edition (Drugs and the Pharmaceutical Sciences)
  6. 2018-01-02[PDF] Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition (Drugs and the Pharmaceutical Sciences)
  7. 2017-11-04[PDF] Controlled Drug Delivery: Fundamentals and Applications, Second Edition (Drugs and the Pharmaceutical Sciences)
  8. 2017-11-02[PDF] Drug Products for Clinical Trials, Second Edition (Drugs and the Pharmaceutical Sciences)
  9. 2018-01-27[PDF] Protein Formulation and Delivery, Second Edition (Drugs and the Pharmaceutical Sciences)
  10. 2017-11-23[PDF] Good Design Practices for GMP Pharmaceutical Facilities, Second Edition (Drugs and the Pharmaceutical Sciences)
  11. 2017-04-05[PDF] Pharmaceutical Process Scale-Up, Second Edition (Drugs and the Pharmaceutical Sciences)
  12. 2018-01-30[PDF] New Drug Approval Process, Fifth Edition (Drugs and the Pharmaceutical Sciences)
  13. 2017-12-02[PDF] Handbook of Pharmaceutical Granulation Technology, Third Edition (Drugs and the Pharmaceutical Sciences)
  14. 2017-10-04[PDF] Good Laboratory Practice Regulations, Fourth Edition (Drugs and the Pharmaceutical Sciences)
  15. 2007-10-16Generic Drug Development: Solid Oral Dosage Forms (Drugs and the Pharmaceutical Sciences)
  16. 2017-11-19[PDF] Generic Drug Product Development: Bioequivalence Issues (Drugs and the Pharmaceutical Sciences)
  17. 2018-01-27[PDF] Biosimilar Drug Product Development (Drugs and the Pharmaceutical Sciences)
  18. 2018-01-09[PDF] How to Develop Robust Solid Oral Dosage Forms: From Conception to Post-Approval
  19. 2017-01-05[PDF] How to Develop Robust Solid Oral Dosage Forms: From Conception to Post-Approval
  20. 2009-09-17Preformulation in Solid Dosage Form Development (Drugs and the Pharmaceutical Sciences)

Comments

No comments for "[PDF] Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition (Drugs and the Pharmaceutical Sciences)".


    Add Your Comments
    1. Download links and password may be in the description section, read description carefully!
    2. Do a search to find mirrors if no download links or dead links.
    Back to Top