Full Description
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 modelling 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.
Contents
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.
