000 05789cam a2200529Ii 4500
001 9781315374215
003 FlBoTFG
005 20220509192936.0
006 m o d
007 cr cnu|||unuuu
008 200130s2020 flua ob 001 0 eng d
040 _aOCoLC-P
_beng
_erda
_epn
_cOCoLC-P
020 _a9781315374215
_q(electronic bk.)
020 _a1315374218
_q(electronic bk.)
020 _a9781315356648
_q(electronic bk. : EPUB)
020 _a1315356643
_q(electronic bk. : EPUB)
020 _z9781466582705
020 _a9781466582712
_q(electronic bk. : PDF)
020 _a1466582715
_q(electronic bk. : PDF)
020 _a9781315337586
_q(electronic bk. : Mobipocket)
020 _a1315337584
_q(electronic bk. : Mobipocket)
035 _a(OCoLC)1138019456
035 _a(OCoLC-P)1138019456
050 4 _aRM151
_b.D47 2020eb
072 7 _aMED
_x017000
_2bisacsh
072 7 _aMED
_x071000
_2bisacsh
072 7 _aMED
_x072000
_2bisacsh
072 7 _aTDCW
_2bicssc
082 0 4 _a615/.6
_223
245 0 0 _aDermal drug delivery :
_bfrom innovation to production /
_cedited by Tapash K. Ghosh.
264 1 _aBoca Raton :
_bCRC Press, Taylor & Francis Group,
_c[2020]
264 4 _c©2020
300 _a1 online resource :
_billustrations (some color)
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
520 _aWith the continued advancement of better-quality control and patient outcome reporting systems, changes in the development, control, and regulation of all pharmaceutical delivery systems including transdermal and topical products have been happening on a continuous basis. In light of various quality issues that have been reported by patients and practitioners resulting in the recall or removal of products from the market, both the pharmaceutical industries and regulatory agencies have been adopting new measures to address these issues. With chapters written by experts in this field, this book takes a 21st century multidisciplinary and cross-functional look at these dosage forms to improve the development, design, manufacturing, quality, clinical performance, safety, and regulation of these products. This book offers a wealth of up-to-date information organized in a logical sequence corresponding to various stages of research, development, and commercialization of dermal drug delivery products. The authors have been carefully selected from different sectors of pharmaceutical science for their expertise in their selected areas to present objectively a balanced view of the current state of these products development and commercialization via regulatory approval. Their insights will provide useful information to others to ensure the successful development of the next generation dermal drug products. Key Features: Presents current advancements including new technologies of transdermal and topical dosage forms. Presents challenges in the development of the new generation of transdermal and topical dosage forms. Introduces new technologies and QbD (quality by design) aspects of manufacturing and control strategies. Includes new perspectives on pre-clinical and clinical development, regulatory considerations, safety and quality. Discusses regulatory challenges, gaps, and future considerations for dermal drug delivery systems.
505 0 _aChapter 1 Dermal and Transdermal Drug Delivery Systems: An Overview and Recent Advancements Kenneth A Walters & Majella E Lane Chapter 2 Preclinical and Clinical Safety and Assessment of Transdermal and Topical Dermatological Products Lindsey C. Yeh & Howard I. Maibach Chapter 3 Selection considerations for membranes and models for in-vitro/ex-vivo permeation studies Pei-Chin Tsai, Tannaz Ramezanli, Dina Wadie, Sonia Trehan, Nathaly Martos, Zheng Zhang, Bozena Michniak-Kohn Chapter 4 Design, Development, Manufacturing and Testing of Transdermal Drug Delivery Systems Timothy A. Peterson, Steven M. Wick & Chan Ko Chapter 5 Quality by Design (QbD) principles in the development of Transdermal Drug Delivery Products Muralikrishnan Angamuthu, H.N. Shivakumar & S. Narasimha Murthy Chapter 6 Microneedles for Drug Delivery: Industrial and Regulatory Perspectives Lisa A. Dick, Dan M. Dohmeier, Ann M. Purrington & Scott A. Burton Chapter 7 Biopharmaceutics Aspects of Dermally Applied Drug Delivery Systems Tapash Ghosh Chapter 8 Quality and Performance Tests for Dermal Drug Delivery Systems Margareth R.C. Marques, Tony Bennett & Gregory Fieldson Chapter 9 Perspective on Clinical Trials for Dermal Drug Delivery Systems John T. Farrar & Shamir Kalaria Chapter 10 Regulatory Standards for Approval of Topical Dermatological Drug Products April C. Braddy & Dale P. Conner Chapter 11 Gaps and Future Considerations for Development of Dermal Transdermal and Topical Delivery Systems Caroline Stransinger Chapter 12 Regulatory Challenges in Chemistry, Manufacturing and Controls: Gaps and Future Consideration for Locally Acting Topical Dermal Systems Shulin Ding Chapter 13 Development of Topical and Transdermal Dosage Forms: Regulatory Perspective Amit Mitra & Sarah A. Ibrahim Chapter 14 Innovations and Future Prospects of Dermal Delivery Systems Rashmi Upasani, Anushree Herwadkar, Neha Singh and Ajay K. Banga
588 _aOCLC-licensed vendor bibliographic record.
650 7 _aMEDICAL / Dermatology
_2bisacsh
650 7 _aMEDICAL / Pharmacology
_2bisacsh
650 7 _aMEDICAL / Pharmacy
_2bisacsh
650 0 _aTransdermal medication.
650 0 _aDrug delivery systems.
700 1 _aGhosh, Tapash K.,
_eeditor.
856 4 0 _3Taylor & Francis
_uhttps://www.taylorfrancis.com/books/9781315374215
856 4 2 _3OCLC metadata license agreement
_uhttp://www.oclc.org/content/dam/oclc/forms/terms/vbrl-201703.pdf
999 _c126975
_d126975