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Handbook of Pharmaceutical Manufacturing Formulations

Sterile Products

Safaraz K. Niazi

$96.99

Paperback

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English
CRC Press
14 October 2024
No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing sterile products has evolved into a very sophisticated industry.

Highlights from Sterile Products, Volume Six include:

formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, and cGMP compliance, all of which are tied together in the final preparation of the CMC sections of regulatory applications specifications of a manufacturing facility to manufacture compliant sterile products NDA or aNDA filing requirements of sterile products an alphabetical presentation of formulations of pharmaceutical products based on their generic names
By:  
Imprint:   CRC Press
Country of Publication:   United Kingdom
Edition:   2nd edition
Dimensions:   Height: 280mm,  Width: 210mm, 
Weight:   843g
ISBN:   9781032931302
ISBN 10:   1032931302
Pages:   458
Publication Date:  
Audience:   Professional and scholarly ,  Undergraduate
Format:   Paperback
Publisher's Status:   Active

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