Part I. Percutaneous Absorption
1 Percutaneous Absorption ...................................... 3
Michael S. Leo and Howard I. Maibach
2 Animal Modeis for Percutaneous Absorption ................... 21
Eui Chang Jung and Howard I. Maibach
3 Mitigating Dermal Exposure to Agrochemicals ................. 41
Robert P. Chilcott
Part II. In Vitro Drug Release
4 Importance of In Vitro Drug Release ......................... 61
Vinod P. Shah and Roger L. Williams
5 Diffusion Cell Design ....................................... 79
Jon R. Heylings
6 In Vitro Product Quality Tests and Product Performance
Tests for Topical and Transdermal Drug Products ............. 81
Avraham Yacobi, Clarence T. Ueda and Vinod P. Shah
7 Safety and Efficacy Testing of Topical Products; Practical
Considerations .............................................. 91
Rashmikant Mohile
Part III. Bioequivalence of Topical Drug Products
8 Challenges in Evaluating Bioequivalence of Topical
Dermatological Drug Products ............................... 101
Vinod P. Shah and Roger L. Williams
9 Methods for the Assessment of Bioequivalence of Topical
Dosage Forms: Correlations, Optimization Strategies,
and Innovative Approaches .................................. 113
Isadore Kanfer
10 Application of Microdialysis in Assessing Cutaneous
Bioavailability ............................................ 153
Eva Benfeldt
Part IV. Bioequivalence: Targeted Drug Delivery
11 Follicular Drug Penetration ................................ 169
Jürgen Lademann and Alexa Patzelt
12 Development of Pilosebaceous Unit-Targeted Drug Products ... 181
Guang Wei Lu, Kevin S. Warner and Fangjing Wang
13 Deep Percutaneous Penetration into Muscles and Joints:
Update ..................................................... 217
Vladyslava Doktor, Christine M. Lee and Howard I. Maibach
14 Efficacy and Toxicity of Microneedle-Based Devices ......... 237
Michael S. Leo, Hadar A. Lev-Tov, Faranak Kamangar,
Howard I. Maibach and Raja K. Sivamani
Part V. Transdermal Drugs and Modelling
15 Mathematical Models for Topical and Transdermal Drug
Products ................................................... 249
Yuri G. Anissimov and Michael S. Roberts
16 Transdermal Patches: An Industrial Perspective
on the Relevance of In Vitro Skin Permeation Studies
and Approaches on Design of Manufacturing Processes ........ 299
Björn Schurad and Marieke Gosau
17 Transdermal Drug Delivery Systems .......................... 319
Vinod P. Shah and Roger L. Williams
Part VI. Clinical Studies and Bioequivalence
18 Dermal Estradiol and Testosterone Transfer in Man:
Existence, Models, and Strategies for Prevention ........... 331
Aaron Gandhi, K. L. Busse and Howard I. Maibach
19 Effects of Occlusion on Dermal Drug Delivery: Implications
for Bioequivalence Measurement ............................. 351
Nilab Osman and Howard I. Maibach
20 Challenges with Clinical Endpoints - Bioequivalence ........ 361
Garrett Coman, Nicholas Blickenstaff and Howard
I. Maibach
21 Clinical Considerations of Bioequivalence for Topical
Dermatologie Drugs ......................................... 371
Jessica Schweitzer and Howard I. Maibach
Part VII. Guidelines and Workshop Report
22 OECD Test Guideline 428 - A Method for In Vitro
Percutaneous Absorption Measurement? ....................... 381
John Jenner
23 Bioequivalence, Quality, and Novel Assessment Technologies
for Topical Products: Current Challenges and Future
Prospects .................................................. 389
Vinod P. Shah, Avraham Yacobi and Majella E. Lane
Index ......................................................... 399
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