Topical Drug Bioavailability, Bioequivalence, and Penetration

Author:   Vinod P. Shah ,  Howard I. Maibach ,  John Jenner
Publisher:   Springer-Verlag New York Inc.
Edition:   Softcover reprint of the original 2nd ed. 2014
ISBN:  

9781493938568


Pages:   402
Publication Date:   05 October 2016
Format:   Paperback
Availability:   Manufactured on demand   Availability explained
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Topical Drug Bioavailability, Bioequivalence, and Penetration


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Author:   Vinod P. Shah ,  Howard I. Maibach ,  John Jenner
Publisher:   Springer-Verlag New York Inc.
Imprint:   Springer-Verlag New York Inc.
Edition:   Softcover reprint of the original 2nd ed. 2014
Dimensions:   Width: 15.50cm , Height: 2.20cm , Length: 23.50cm
Weight:   6.263kg
ISBN:  

9781493938568


ISBN 10:   1493938568
Pages:   402
Publication Date:   05 October 2016
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   Manufactured on demand   Availability explained
We will order this item for you from a manufactured on demand supplier.

Table of 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.

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Author Information

Vinod P. Shah is a pharmaceutical consultant. He was Scientific Secretary of International Pharmaceutical Federation (FIP) and is now Chair of Regulatory Sciences Special Interest Group of FIP. 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. Dr. Shah is a fellow of FIP as well as the American Association of Pharmaceutical Scientists (AAPS), where he served as president for a year. He is a recipient of an honorary doctorate from Semmelweis University, Budapest, Hungary.   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. Prof. Maibach has served on the editorial boards of more than thirty scientific journals and is a member of many professional societies, including the American Academy of Dermatology and the International Commission on Occupational Health. 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. His current interests include the translation of in vitro penetration measurements to in vivo using mathematical modelling.

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