000			05509pam a2200433 i 4500
999			_c12503 _d12503
001			28722190
005			20210222150432.0
008			930810s1993 nyua b 001 0 eng c
010			_a93030560
015			_aGB93-69265
020			_a0306443678
040			_aDNLM/DLC _cDLC _dNLM _dUKM _dEG-NcFUE _erda
050	0	0	_aRM151 _b.T658 1993
060	0		_aWB 340 T673 1993
082	0	0	_a615.6 _223 _bT
245	0	0	_aTopical drug bioavailability, bioequivalence, and penetration / _cedited by Vinod P. Shah and Howard I. Maibach
264		1	_aNew York : _bPlenum Press, _cc1993
264		4	_cc1993
300			_axxii, 453 pages. : _billustrations. ; _c24 cm
336			_2rdacontent _atext
337			_2rdamedia _aunmediated
338			_2rdacarrier _avolume
504			_aIncludes bibliographical references and index
505	0		_a1 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.
520			_ahis 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
650		0	_aTherapeutics, Cutaneous and external
650		0	_aBioavailability
650		0	_aDrugs _xTherapeutic equivalency
650		0	_aSkin _xPermeability
650		2	_aAdministration, Cutaneous
650		2	_aBiological Availability
650		2	_aDrug Delivery Systems
650		2	_aSkin Absorption
650		2	_aTherapeutic Equivalency
700	1	0	_aShah, Vinod P _eeditor
700	1	0	_aMaibach, Howard I _eeditor
942			_2ddc _cBK