Specification of drug substances and products : development and validation of analytical methods / edited by Christopher M. Riley, Riley and Rabel Consulting Services, Maryville, MO, USA, Thomas W. Rosanske, T.W. Rosanske Consulting, Overland Park, KS, USA, Shelley R. Rabel Riley, Department of Natural Sciences, Northwest Missouri, State University, Maryville, MO, USA, Riley and Rabel Consulting Services, Maryville, MO, USA.

Format:

Book

Contributor:

Riley, Christopher M., editor.

Rosanske, Thomas W., editor.

Riley, Shelley R. Rabel, editor.

Series:

Progress in Pharmaceutical and Biomedical Analysis

Language:

English

Subjects (All):

Drugs--Standards.

Drugs.

Drug development.

Physical Description:

1 online resource (viii, 380 pages) : illustrations (some color)

Edition:

2nd ed.

Place of Publication:

Amsterdam : Elsevier, 2014.

Language Note:

English

Summary:

Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future d

Contents:

part 1. Introduction

part 2. Universal tests

part 3. Specific tests : drug substance

part 4. Specific tests : drug product

part 5. Pharmacopeial methods

part 6. Microbial methods

part 7. Biological fluids.

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on online resource; title from PDF title page (ebrary, viewed October 8, 2013).

ISBN:

9780080983431

008098343X

OCLC:

880437636