Topical Drug Bioavailability, Bioequivalence, and Penetration

  • Vinod P. Shah
  • Howard I. Maibach
  • John Jenner

Table of contents

  1. Front Matter
    Pages i-xiii
  2. Percutaneous Absorption

    1. Front Matter
      Pages 1-1
    2. Michael S. Leo, Howard I. Maibach
      Pages 3-19
    3. Eui Chang Jung, Howard I. Maibach
      Pages 21-40
    4. Robert P. Chilcott
      Pages 41-57
  3. In Vitro Drug Release

    1. Front Matter
      Pages 59-59
    2. Vinod P. Shah, Roger L. Williams
      Pages 61-67
    3. Jon R. Heylings
      Pages 69-80
  4. Bioequivalence of Topical Drug Products

  5. Bioequivalence: Targeted Drug Delivery

    1. Front Matter
      Pages 167-167
    2. Jürgen Lademann, Alexa Patzelt
      Pages 169-179
    3. Guang Wei Lu, Kevin S Warner, Fangjing Wang
      Pages 181-215
    4. Vladyslava Doktor, Christine M. Lee, Howard I. Maibach
      Pages 217-235
    5. Michael S. Leo, Hadar A. Lev-Tov, Faranak Kamangar, Howard I. Maibach, Raja K. Sivamani
      Pages 237-246
  6. Transdermal Drugs and Modelling

    1. Front Matter
      Pages 247-247
    2. Yuri G. Anissimov, Michael S. Roberts
      Pages 249-298
    3. Vinod P. Shah, Roger L. Williams
      Pages 319-328
  7. Clinical Studies and Bioequivalence.

    1. Front Matter
      Pages 329-329
    2. Garrett Coman, Nicholas Blickenstaff, Howard I. Maibach
      Pages 361-370
    3. Jessica Schweitzer, Howard I. Maibach
      Pages 371-377
  8. Guidelines and Workshop Report

  9. Back Matter
    Pages 399-402

About this book


This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations. Seven comprehensive sections examine topics including in vitro drug release, topical drugs products, clinical studies, and guidelines and workshop reports, among others. The book also describes how targeted transdermal drug delivery and more sophisticated mathematical modeling can aid in understanding the bioavailability of transdermal drugs.

The first edition of this book was an important reference guide for researchers working to define the effectiveness and safety of drugs and chemicals that penetrated the skin. This second edition contains cutting-edge advances in the field and is a key resource to those seeking to define the bioavailability and bioequivalence of percutaneously active compounds to improve scientific and clinical investigation and regulation.


Vinod P. Shah is a pharmaceutical consultant. He was Scientific Secretary of the International Pharmaceutical Federation (FIP) and is now Chair of the FIP Regulatory Sciences Special Interest Group. Dr. Shah has served at the U.S. Food and Drug Administration and has developed several regulatory guidances for the pharmaceutical industry in biopharmaceutics and topical drug products.

Howard I. Maibach is professor of dermatology at the University of California, San Francisco. He received his M.D. at Tulane University Medical School in New Orleans, Louisiana, and completed his residency and research fellowships at the University of Pennsylvania in Philadelphia, Pennsylvania. Professor Maibach is a leading authority in the fields of dermatotoxicology and dermatopharmacology, in which he has conducted research and written extensively.

John Jenner is a principal scientist at The Defence Science and Technology Laboratory in the UK. He has a degree in pharmacology from the University of Manchester in Manchester, UK, and a Ph.D. from the University of Surrey, Guildford, UK. John has spent his career studying defense against and treatment of highly toxic chemicals. He has an enduring research interest in percutaneously active chemicals, whether toxic materials or drugs, and experience in the design and testing of transdermal formulations.


bioavailability bioequivalence drug release penetration quality test topical drugs

Editors and affiliations

  • Vinod P. Shah
    • 1
  • Howard I. Maibach
    • 2
  • John Jenner
    • 3
  1. 1.Pharmaceutical ConsultantNorth PotomacUSA
  2. 2.University of California, San Francisco School of Medicine, Department of DermatologySan FranciscoUSA
  3. 3.The Defence Science and Technology Laboratory, Biomedical Sciences DepartmentSalisburyUnited Kingdom

Bibliographic information