Sample Preparation of Pharmaceutical Dosage Forms

Challenges and Strategies for Sample Preparation and Extraction

  • Beverly Nickerson

Table of contents

  1. Front Matter
    Pages i-xiv
  2. Introduction

    1. Front Matter
      Pages 1-1
    2. Dawen Kou, Hua Ma, Edmund J. Bishop, Shangdong Zhan, Hitesh P. Chokshi
      Pages 21-39
  3. Extraction and Sample Preparation Techniques

    1. Front Matter
      Pages 41-41
    2. Beverly Nickerson, K. Rick Lung
      Pages 43-61
    3. Beverly Nickerson, Ivelisse Colón
      Pages 63-92
    4. Daniel Brannegan, Carlos Lee, Jian Wang, Larry Taylor
      Pages 93-128
  4. Sample Preparation Method Development and Validation for Various Dosage Form Types

    1. Front Matter
      Pages 129-129
    2. Carlos Lee
      Pages 131-143
    3. Beverly Nickerson, Garry Scrivens
      Pages 145-178
    4. Xin Bu, Sachin Chandran, John Spirig, Qinggang Wang
      Pages 179-210
    5. Ivelisse Colón
      Pages 211-232
    6. Edmund J. Bishop, Dawen Kou, Gerald Manius, Hitesh P. Chokshi
      Pages 233-251
    7. Jackson D. Pellett, Beverly Nickerson, Ivelisse Colón
      Pages 253-281
  5. Additional Sample Preparation Topics

    1. Front Matter
      Pages 283-283
    2. Gang Xue, K. Rick Lung
      Pages 285-307
    3. Beverly Nickerson, Ivelisse Colón, Eddie Ebrahimi, Garry Scrivens, Lin Zhang
      Pages 309-332
    4. Paul Ferguson, Mark Harding
      Pages 333-354
    5. Yang (Angela) Liu, George L. Reid, Zhongli Zhang
      Pages 355-385

About this book

Introduction

Designed as a resource guide for analytical scientists working in the pharmaceutical industry, this comprehensive guide is focused entirely on sample preparation and extraction of pharmaceutical dosage forms. 

 

This book is divided into four parts:

•          Part One covers dosage form and diluent properties that impact sample preparation of pharmaceutical dosage forms and the importance of sampling considerations in generating data representative of the drug product batch. 

•          Part Two reviews specific sample preparation techniques typically used with pharmaceutical dosage forms.

•          Part Three discusses sample preparation method development for different types of dosage forms including addressing drug excipient interactions and post extraction considerations, as well as method validation and applying Quality by Design (QbD) principles to sample preparation methods.  

•          Part Four examines additional topics in sample preparation including automation, investigating aberrant potency results, green chemistry considerations for sample preparation and the ideal case where no sample preparation is required for sample analysis.

 

Analytical scientists in the pharmaceutical industry as well as in analytical testing laboratories will find this book a valuable resource in developing and troubleshooting sample preparation methods for drug products at all stages in the lifecycle of a drug product.

Beverly Nickerson, Ph.D., is Associate Research Fellow in Analytical Development in Pfizer Global Research and Development, Pfizer Inc.  Dr. Nickerson is well published in peer-reviewed journals, is author of several book chapters and has presented at various scientific meetings.  She has extensive experience in early stage and late stage drug development.

Keywords

Challenges Dosage Extraction Form Nickerson Pharmaceutical Preparation Sample Strategies Strategy

Editors and affiliations

  • Beverly Nickerson
    • 1
  1. 1.Pfizer Global Research & Development, Analytical Research & Development Dept.Pfizer Inc.GrotonUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-1-4419-9631-2
  • Copyright Information American Association of Pharmaceutical Scientists 2011
  • Publisher Name Springer, Boston, MA
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-1-4419-9630-5
  • Online ISBN 978-1-4419-9631-2
  • About this book