The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies.

After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies.

To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.

About the Author

Shein-Chung Chow

"About this title" may belong to another edition of this title.

Store Description

The Saint Bookstore has a range of over 1 million titles available.

Visit Seller's Storefront

Seller's business information

SB ONLINE LTD
50 Devonshire Road, Southport, PR9 7BZ, United Kingdom

Sale & Shipping Terms

Terms of Sale

Please order through the Abebooks checkout. We only take orders through Abebooks - We don't take direct orders by email or phone.

Refunds or Returns: A full refund of the purchase price will be given if returned within 30 days in undamaged condition.

As a seller on abebooks we adhere to the terms explained at http://www.abebooks.co.uk/docs/HelpCentral/buyerIndex.shtml - if you require further assistance please email us at orders@thesaintbookstore.co.uk

Shipping Terms

Most orders usually ship within 1-3 business days, but some can take up to 7 days.

Shipping rates from United Kingdom to U.S.A.

Shipping rates from United Kingdom to U.S.A.
Order quantity	7 to 28 business days	7 to 28 business days
First item	US$ 22.92	US$ 25.59

Delivery times are set by sellers and vary by carrier and location. Orders passing through Customs may face delays and buyers are responsible for any associated duties or fees. Sellers may contact you regarding additional charges to cover any increased costs to ship your items.