Topical Drug Bioavailability, Bioequivalence, and Penetration [electronic resource] /
Shah, Vinod P.editor.
Maibach, Howard I.editor.
Jenner, John.editor.
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.
Description based upon print version of record.
Includes bibliographical references and index.
1 Percutaneous Absorption -- 2 Animal Models for Percutaneous Absorption -- 3 Mitigating Dermal Exposure to Agrochemicals -- 4 Importance of In Vitro Drug Release -- 5 Diffusion Cell Design -- 6 In Vitro Product Quality Tests and Product Performance Tests for Topical and Transdermal Drug Products -- 7 Safety and efficacy testing of topical products; Practical considerations -- 8 Challenges in Evaluating Bioequivalence of Topical Dermatological Drug Products -- 9 Methods for the Assessment of Bioequivalence of Topical Dosage Forms: Correlations, Optimization Strategies and Innovative Approaches -- 10 Application of Microdialysis in Assessing Cutaneous Bioavailability -- 11 Follicular Drug Penetration -- 12 Development of Pilosebaceous Unit-Targeted Drug Products -- 13 Deep Percutaneous Penetration into Muscles and Joints: Update -- 14 Efficacy & Toxicity of Microneedle based devices -- 15 Mathematical Models for Topical and Transdermal Drug Products -- 16 Transdermal Patches: An Industrial Perspective on the Relevance of in vitro Skin Permeation Studies and Approaches on Design of Manufacturing Processes -- 17 Transdermal Drug Delivery Systems.  Regulatory Considerations:  NDA and ANDA Requirements -- 18 Transdermal Estradiol and Testosterone Transfer in Man: Existence, Models, and Strategies for Prevention -- 19 Effects of occlusion on dermal drug delivery: implications for bioequivalence measurement -- 20 Challenges with Clinical Endpoints – Bioequivalence -- 21 Clinical Considerations of Bioequivalence For Topical Dermatologic Drugs -- 22 OECD Test Guideline 428 – A method for in vitro percutaneous absorption measurement? -- 23 Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products: Current Challenges and Future Prospects.
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.
Pharmacology.
Animal physiology.
Biophysics.
Biological physics.
Pharmacology/Toxicology.
Animal Physiology.
Biological and Medical Physics, Biophysics.