Overview

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

Full Product Details

Author:   Safaraz K. Niazi (Pharmaceutical Scientist Inc., Deerfield, Illinois, USA) ,  Safaraz K Niazi (Pharmaceutical Scientist Inc., Deerfield, Illinois, USA)
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Edition:   2nd New edition
Dimensions:   Width: 21.60cm , Height: 3.70cm , Length: 27.90cm
Weight:   1.247kg
ISBN:  

9781420081305

ISBN 10:   1420081306
Pages:   464
Publication Date:   01 September 2009
Audience:   Professional and scholarly ,  Professional & Vocational ,  Professional & Vocational
Replaced By:   9781138103832
Format:   Hardback
Publisher's Status:   Out of Stock Indefinitely
Availability:   In Print  
Limited stock is available. It will be ordered for you and shipped pending supplier's limited stock.

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