Statistical Design and Analysis of Stability Studies (Chapman & Hall/crc Biostatistics Series)

個数：

Statistical Design and Analysis of Stability Studies (Chapman & Hall/crc Biostatistics Series)

Chow, Shein-Chung

ウェブストア価格 ¥13,334（本体¥12,122）
Chapman & Hall/CRC（2020/06発売）
外貨定価 US$ 63.99
ポイント 121pt

提携先の海外書籍取次会社に在庫がございます。通常3週間で発送いたします。
【重要ご説明事項】
1. 納期遅延や、ご入手不能となる場合が若干ございます。
2. 複数冊ご注文の場合は、ご注文数量が揃ってからまとめて発送いたします。
3. 美品のご指定は承りかねます。

●3Dセキュア導入とクレジットカードによるお支払いについて

【入荷遅延について】
世界情勢の影響により、海外からお取り寄せとなる洋書・洋古書の入荷が、表示している標準的な納期よりも遅延する場合がございます。
おそれいりますが、あらかじめご了承くださいますようお願い申し上げます。

◆画像の表紙や帯等は実物とは異なる場合があります。

◆ウェブストアでの洋書販売価格は、弊社店舗等での販売価格とは異なります。
また、洋書販売価格は、ご注文確定時点での日本円価格となります。
ご注文確定後に、同じ洋書の販売価格が変動しても、それは反映されません。

製本 Paperback:紙装版/ペーパーバック版／ページ数 348 p.
言語 ENG
商品コード 9780367577681
DDC分類 615.1901

Full Description

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.

Introduction. Accelerated Testing. Expiration Dating Period. Stability Designs. Stability Analysis with Fixed Batches. Stability Analysis with Random Batches. Stability Analysis with a Mixed Effects Model. Stability Analysis with Discrete Responses. Stability Analysis with Multiple Components. Stability Analysis with Frozen Drug Products. Stability Testing for Dissolution. Current Issues and Recent Developments. Appendices. References. Index.