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Author : Umesh V. Banakar,David W. Osborne
Publisher : Unknown
Page : 178 pages
File Size : 51,5 Mb
Release : 1993
Category : Dermatologic agents
ISBN : 1566760623
Author : Tomoko Maeda-Chubachi,Elizabeth Kernodle Hussey,Sylvia Furst
Publisher : Cambridge Scholars Publishing
Page : 146 pages
File Size : 45,7 Mb
Release : 2020-09-18
Category : Medical
ISBN : 9781527559677
This book uniquely summarizes approaches to developing dermatological drugs in a regulated environment from the perspective of the pharmaceutical industry. It brings together the insights of skilled and experienced industry experts to reveal the complexities of dermatological drug development, covering topical, oral, and biologic drugs. This book fills an important gap, as there is currently no other textbook addressing dermatological drug development, explaining and illustrating why unique nonclinical and clinical studies are necessary and how they are typically designed and conducted. The drug development process is also an evolving strategy that is characterized by communicating, negotiating, and agreeing with regulatory agencies, such as FDA (US), EMA (EU), and PMDA (Japan).
Author : Heather A. E. Benson,Adam C. Watkinson
Publisher : John Wiley & Sons
Page : 393 pages
File Size : 44,9 Mb
Release : 2012-02-03
Category : Medical
ISBN : 9781118140499
Practical drug development approaches presented by leading experts Designed to support the development of new, effective therapeutics, Topical and Transdermal Drug Delivery: Principles and Practice explains the principles underlying the field and then demonstrates how these principles are put into practice in the design and development of new drug products. Drawing together and reviewing the latest research findings, the book focuses on practical, tested, and proven approaches that are backed by industry case studies and the authors' firsthand experience. Moreover, the book emphasizes the mechanistic information that is essential for successful drug product development. Topical and Transdermal Drug Delivery: Principles and Practice is divided into two parts: Part One, Current Science, Skin Permeation, and Enhancement Approaches, offers readers a fundamental understanding of the underlying science in the field. It describes the principles and techniques needed to successfully perform experimental approaches, covering such issues as skin permeation, enhancement, and assessment. Part Two, Topical and Transdermal Product Development, guides readers through the complete product development process from concept to approval, offering practical tips and cautions from experts in the field. This part also discusses regulations that are specific to the development of dermal drug products. The final chapter explores current and future trends, forecasting new development techniques and therapeutics. Throughout the book, the authors clearly set forth the basic science and experimental procedures, making it possible for researchers to design their own experimental approaches and accurately interpret their results. With contributions from experienced drug researchers, this text is highly recommended for all researchers involved in topical and transdermal product development who need to know both the state of the science and the standards of practice.
Author : Lionel Trottet,Howard Maibach, MD
Publisher : Springer
Page : 148 pages
File Size : 49,9 Mb
Release : 2017-08-07
Category : Medical
ISBN : 9783319595047
The authors show how the pharmaceutical industry faces the development of dermal drugs and provide the only book of its kind that describes how the industry develops and selects dermal drugs, complete with the challenges and opportunities of the field. Delivery of drugs through the skin has been an attractive and challenging area for research, and advances in modern technologies have resulted in a larger number of drugs being delivered transdermally, including conventional hydrophobic small molecule drugs, hydrophilic drugs and macromolecules. Offering the perspective from the industrial side of selection and development of drugs, the primary audience is geared towards the pharmaceutical industry but can also offer valuable information to clinicians, compounding pharmacists, and similarly pharmacy students. Dermal Drug Selection and Development covers the scientific gaps that exist in terms of dermal pharmacokinetics and the resulting uncertainty by clinicians when choosing a drug candidate.
Author : Tapash K. Ghosh
Publisher : CRC Press
Page : 463 pages
File Size : 51,9 Mb
Release : 2020-01-21
Category : Medical
ISBN : 9781466582712
With 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.
Author : Marc B. Brown,Adrian C. Williams
Publisher : CRC Press
Page : 340 pages
File Size : 54,6 Mb
Release : 2019-03-01
Category : Medical
ISBN : 9780429594779
The Art and Science of Dermal Formulation Development is a comprehensive guide to the theory and practice of transdermal and topical formulation development, covering preclinical studies, evaluation, and regulatory approval. It enables the reader to understand the opportunities and challenges in developing products and how risks can be mitigated. Over the last 25 years, expertise in this area has declined whilst drug delivery systems for other administration routes have developed significantly. The advantages offered by transdermal and topical drug delivery remain compelling for sectors including the pharmaceutical industry, personal care, and cosmetics. This text addresses the dearth of expertise and discusses how skin can be a route of delivery and the processes in formulation development, but how such an application is very different to that used for oral, IV, and other administration routes. Key Features: Presents a practical guide for both industry and academia Focuses on and draws together the fundamental principles behind transdermal and topical drug delivery Illustrates the practicalities of formulation design using key case studies Gives an understanding of the skin as a route of delivery and how formulation development for such application differs from that for other administration routes
Author : Markham C. Luke
Publisher : Elsevier Health Sciences
Page : 121 pages
File Size : 42,6 Mb
Release : 2022-06-24
Category : Medical
ISBN : 9780323849708
In this issue, guest editors bring their considerable expertise to this important topic. Provides in-depth reviews on the latest updates in the field, providing actionable insights for clinical practice. Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field. Authors synthesize and distill the latest research and practice guidelines to create these timely topic-based reviews.
Author : B. Gabard,P. Elsner,C. Surber,P. Treffel
Publisher : Springer Science & Business Media
Page : 466 pages
File Size : 42,7 Mb
Release : 2011-06-28
Category : Medical
ISBN : 9783642571459
Proof of the efficacy of dermatological products is a prerequisite for clinical testing and registration. Now, efficacy claims for cosmetics must be equally substantiated. This book provides a concise, practical but comprehensive overview of experimental models used to screen, develop and select dermatological and cosmetic formulations. The authors are recognized specialists in their field and use a standardized approach to the projects facilitating the reading for the stressed scientist, for the R+D managers general view as well as for the beginners in the field.
Author : Kenneth A. Walters
Publisher : CRC Press
Page : 592 pages
File Size : 51,7 Mb
Release : 2002-02-20
Category : Medical
ISBN : 9780824743239
Containing 350 illustrations, tables, and equations and covering AAPS/FDA guidelines for the experimentation and analysis of in vivo and in vitro percutaneous absorption, this reference provides comprehensive coverage of the development, preparation, and application of topical and transdermal therapeutic systems. Recognized international experts di
Author : Keith R Brain,Robert P Chilcott
Publisher : Royal Society of Chemistry
Page : 476 pages
File Size : 52,5 Mb
Release : 2013
Category : Medical
ISBN : 9781849733984
Readily accessible, yet detailed, this book presents cutting-edge advances in the field of dermatological sciences.
Author : Nigel Langley,Bozena Michniak-Kohn,David W. Osborne
Publisher : Springer
Page : 199 pages
File Size : 48,9 Mb
Release : 2019-08-07
Category : Medical
ISBN : 9783030173555
Following the Semi-solid Microstructure Workshop sponsored by BASF and hosted by the Rutgers Center for Dermal Research, a pharmaceutical product development working group was formed. The group, known as the Q3 Working Group, selected the following five areas of focus: Particle/Globule Size and Distribution, Viscosity/Rheology/Spreadability, In Vitro Testing, State of API, State of Excipients. A committee was appointed for each of these five areas. The committees were tasked to review the literature, identify best practices, list experimental details required for an independent lab to duplicate the test, and propose scientific studies that may meaningfully advance this specific area of focus. Each committee has a chair (or co-chairs) that are the lead author(s) of the chapter. The Q3 Working Group members serve as the critical reviewers of each chapter, making suggestions that improve the quality of the document and that make each of the five chapters uniform in scope and content.Pharmaceutical development scientists that formulate topical products (creams, lotions, gels suspensions, foams, etc) and all the allied raw material suppliers, packaging suppliers, contract laboratories including CROs, CMOs and regulators need access to this book. Overall, the topic of semisolid microstructure is of equal importance to the generic pharmaceutical companies (filing Abbreviated New Drug Applications or ANDAs) and pharmaceutical companies filing New Drug Applications (NDAs). In addition to products applied to the skin, hair, and nails, The Role of Microstructure in Topical Drug Product Development’ crosses over and is essential reading to developers of oral suspensions, ophthalmic ointments and gels, otic suspension, vaginal semisolids and retention enemas.
Author : Marc B. Brown,Adrian C. Williams
Publisher : CRC Press
Page : 248 pages
File Size : 50,7 Mb
Release : 2019
Category : Medical
ISBN : 0429059876
The Art and Science of Dermal Formulation Development is a comprehensive guide to the theory and practice of transdermal and topical formulation development, covering preclinical studies, evaluation, and regulatory approval. It enables the reader to understand the opportunities and challenges in developing products and how risks can be mitigated. Over the last 25 years, expertise in this area has declined whilst drug delivery systems for other administration routes have developed significantly. The advantages offered by transdermal and topical drug delivery remain compelling for sectors including the pharmaceutical industry, personal care, and cosmetics. This text addresses the dearth of expertise and discusses how skin can be a route of delivery and the processes in formulation development, but how such an application is very different to that used for oral, IV, and other administration routes. Key Features: Presents a practical guide for both industry and academia Focuses on and draws together the fundamental principles behind transdermal and topical drug delivery Illustrates the practicalities of formulation design using key case studies Gives an understanding of the skin as a route of delivery and how formulation development for such application differs from that for other administration routes
Author : Kenneth A. Walters,Michael S. Roberts
Publisher : CRC Press
Page : 644 pages
File Size : 54,6 Mb
Release : 2007-12-13
Category : Medical
ISBN : 9780849375903
Recent advances in our understanding of the development and morphology of normal skin have led to improved methods to deliver therapeutic compounds to targeted areas both within the skin and systemically. This reference provides a clear overview of pharmaceutical and cosmetic practices, drugs, and therapies to manage and treat major and minor skin disorders. It examines the efficiency and delivery of topical therapies and explains how percutaneous absorption is affected by age, skin, site, race, skin disease, and damage and product form. Particular emphasis is on novel treatment approaches for major skin diseases and injuries pertaining to wounds and burns.
Author : Vinod P. Shah,Howard I. Maibach,John Jenner
Publisher : Springer
Page : 393 pages
File Size : 42,8 Mb
Release : 2015-01-30
Category : Medical
ISBN : 9781493912896
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.
Author : Vandana B. Patravale,John I. Disouza,Maharukh Rustomjee
Publisher : CRC Press
Page : 433 pages
File Size : 48,6 Mb
Release : 2016-05-25
Category : Medical
ISBN : 9781498730785
Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.
