£137.45

CRC Press Statistical Design and Analysis of Stability Studies

Name: CRC Press Statistical Design and Analysis of Stability Studies
Brand: CRC Press
Price: 137.45 GBP
Availability: InStock

Pharmacy - Dispensing

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Description

Drug recalls are often caused by stability data that fails to support existing expiration dates. This book provides the essential principles and methodologies needed to conduct effective stability studies that characterize drug product degradation and estimate shelf life accurately. As pharmaceutical companies work to ensure drug safety and quality assurance, understanding the design and analysis of these studies is vital. This text explores how stability studies function as a key component in maintaining product integrity. By presenting the core methodologies used in the field, it helps professionals address the challenges identified in US Food and Drug Administration reports regarding drug stability and expiration dating.

Key Features

Provides methodologies for the design and analysis of stability studies to support drug safety.

Helps estimate drug shelf life by characterizing the degradation of drug products.

Addresses critical issues related to drug recalls and expiration date accuracy.

Covers principles used to ensure quality assurance within pharmaceutical manufacturing.

Part of the Chapman and Hall/CRC Biostatistics Series for specialized technical learning.

Product Specifications

Brand: CRC Press
Format: Hardcover
ASIN: 1584889055
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Pharmacy - Dispensing
Domain: Amazon UK
Release Date: 30 May 2007
Listed Since: 05 January 2007

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CRC Press Statistical Design and Analysis of Stability Studies

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