0
Your cart

Your cart is empty

Books > Law > Laws of other jurisdictions & general law > Social law > Public health & safety law

Buy Now

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (Hardcover, 2004 ed.) Loot Price: R5,895
Discovery Miles 58 950
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (Hardcover, 2004 ed.): John Geigert

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (Hardcover, 2004 ed.)

John Geigert

 (sign in to rate)
Loot Price R5,895 Discovery Miles 58 950 | Repayment Terms: R552 pm x 12*

Bookmark and Share

Expected to ship within 10 - 15 working days

"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed."

General

Imprint: Kluwer Academic / Plenum Publishers
Country of origin: United States
Release date: December 2003
First published: 2004
Authors: John Geigert
Dimensions: 254 x 178 x 25mm (L x W x T)
Format: Hardcover
Pages: 350
Edition: 2004 ed.
ISBN-13: 978-0-306-48040-9
Categories: Books > Law > Laws of other jurisdictions & general law > Social law > Public health & safety law
Promotions
LSN: 0-306-48040-9
Barcode: 9780306480409

Is the information for this product incomplete, wrong or inappropriate? Let us know about it.

Does this product have an incorrect or missing image? Send us a new image.

Is this product missing categories? Add more categories.

Review This Product

No reviews yet - be the first to create one!

You might also like..

A-Z Of Nursing Law
David McQuoid-Mason, Mahomed Dada, … Paperback  (1)
R569 R536 Discovery Miles 5 360
Interpreting Medical Findings - In…
Steve R. Naidoo, Sagie Naidoo, … Paperback R337 Discovery Miles 3 370
Technology, Innovation and Healthcare…
Bernadette J. Richards, Mark Taylor, … Hardcover R2,666 Discovery Miles 26 660
Advanced Introduction to International…
Neal D. Fortin Paperback R636 Discovery Miles 6 360
Ending Childhood Obesity - A Challenge…
Amandine Garde, Joshua Curtis, … Hardcover R4,190 Discovery Miles 41 900
Black Health in the South
Steven S. Coughlin, Lovoria B. Williams, … Hardcover R1,919 Discovery Miles 19 190
Human Rights and Tobacco Control
Marie E. Gispen, Brigit Toebes Hardcover R3,672 Discovery Miles 36 720
Advanced Introduction to International…
Neal D. Fortin Hardcover R2,740 Discovery Miles 27 400
From Chasing Violations to Managing…
Florentin Blanc Hardcover R3,879 Discovery Miles 38 790
Curriculum Development for Medical…
Patricia A. Thomas, David E. Kern, … Paperback R1,343 R1,210 Discovery Miles 12 100
Nutraceutical and Functional Food…
Debasis Bagchi Paperback R3,989 R3,772 Discovery Miles 37 720
Genomic Messages - How the Evolving…
George Annas, Sherman Elias Paperback R395 R369 Discovery Miles 3 690

See more

Partners