Novel Drug Delivery Systems And Regulatory Affairs

Author : Sudhakar Yajaman & Jayaveera K.N.
Publisher : S. Chand Publishing
ISBN 13 : 8121942578
Total Pages : pages
Book Rating : 4.77/5 ( download)

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Download or read book Novel Drug Delivery Systems and Regulatory Affairs written by Sudhakar Yajaman & Jayaveera K.N. and published by S. Chand Publishing. This book was released on 2014 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Novel Drug Delivery Systems | Transdermal Drug Delivery Systems | Mucoadhesive Drug Delivery Systems | Targeted Drugdelivery Systems | Regulatory Agencies | Quality Assurance | Good Manufacturing Practices | Validation

Author : B. K. Nanjwade
Publisher : CBS Publishers & Distributors Pvt Limited, India
ISBN 13 : 9789388527453
Total Pages : pages
Book Rating : 4.53/5 ( download)

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Download or read book Novel Drug Delivery Systems and Regulatory Affairs written by B. K. Nanjwade and published by CBS Publishers & Distributors Pvt Limited, India. This book was released on 2019-04-30 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Targeted towards undergraduate and postgraduate students, the purpose of this textbook is to introduce pharmacy students to the basic systems of pharmaceutical principles and technologies applied in the preparation of various novel drug delivery systems. It also provides an in-depth introduction to the regulatory agencies and Current Good Manufacturing Practices (CGMP). This book caters to anyone who is interested in the subject or working in the industry, clinicians and research scholars. It is written in simple, lucid style with easily-understandable language so that it is useful for self study. The illustrations and tables provide a clear understanding of the concepts.

Author : Javed Ali
Publisher : Academic Press
ISBN 13 : 0128222239
Total Pages : 287 pages
Book Rating : 4.32/5 ( download)

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Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance

Author : Antoine Al-Achi
Publisher : John Wiley & Sons
ISBN 13 : 1118356721
Total Pages : 1024 pages
Book Rating : 4.22/5 ( download)

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Download or read book Integrated Pharmaceutics written by Antoine Al-Achi and published by John Wiley & Sons. This book was released on 2013-01-22 with total page 1024 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on the application of physical pharmacy, drug design, and drug regulations as they relate to produce effective dosage forms for drug delivery, Integrated Pharmaceutics provides a comprehensive picture of pharmaceutical product design, describing the science and art behind the concepts of dosage form development. Combining physical pharmacy, product design, and regulatory affairs issues in a single book, the authors address topics governing drug regulations of United States, European, and Japanese agencies and detail new regulatory guidelines, including quality by design, design space analysis, and blend sample uniformity.

Author : John J. Tobin
Publisher : John Wiley & Sons
ISBN 13 : 3527644717
Total Pages : 304 pages
Book Rating : 4.11/5 ( download)

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Download or read book Medical Product Regulatory Affairs written by John J. Tobin and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

Author : Douglas J. Pisano
Publisher : CRC Press
ISBN 13 : 1040061974
Total Pages : 466 pages
Book Rating : 4.78/5 ( download)

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Download or read book FDA Regulatory Affairs written by Douglas J. Pisano and published by CRC Press. This book was released on 2008-08-11 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in

Author : Ranjita Shegokar
Publisher : Elsevier
ISBN 13 : 0128177772
Total Pages : 242 pages
Book Rating : 4.78/5 ( download)

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Download or read book Delivery of Drugs written by Ranjita Shegokar and published by Elsevier. This book was released on 2020-02-01 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: Delivery of Drugs: Expectations and Realities of Multifunctional Drug Delivery Systems, Volume Two examines the formulation of micro-nanosized drug delivery systems and recaps opportunities for using physical methods to improve efficacy via mechano-, electroporation. The book highlights innovative delivery methods like PIPAC, including discussions on the regulatory aspects of complex injectables. Written by a diverse range of international researchers from industry and academia, the chapters examine specific aspects of characterization and manufacturing for pharmaceutical applications as well as regulatory and policy aspects. This book connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stakeholders. This level of discussion makes it a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about the status of drug delivery systems. Delivery of Drugs examines the fabrication, optimization, scale-up, biological aspects, regulatory and clinical success of various micro and nano drug delivery systems. The volume covers site and organ specific targeting approaches, technologies used in preparation of micro - nanoparticles, challenges of complex type of drug delivery forms and role of physical methods in achieving targeted drug effect. Written by a diverse range of international researchers the chapters examine the specific aspects of characterization and manufacturing of drug delivery system for pharmaceutical application and its regulatory aspects. The series Expectations and Realities of Multifunctional Drug Delivery Systems examines the fabrication, optimization, biological aspects, regulatory and clinical success of wide range of drug delivery carriers. This series reviews multifunctionality and applications of drug delivery systems, industrial trends, regulatory challenges and in vivo success stories. Throughout the volumes discussions on diverse aspects of drug delivery carriers, such as clinical, engineering, and regulatory, facilitate insight sharing across expertise area and form a link for collaborations between industry-academic scientists and clinical researchers. Expectations and Realities of Multifunctional Drug Delivery Systems connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stake holders. The wide scope of the book ensures it as a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about drug delivery systems.

Author : Dr. Jayesh Dhalani
Publisher : Lulu.com
ISBN 13 : 0359963234
Total Pages : 127 pages
Book Rating : 4.32/5 ( download)

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Download or read book Basics of Regulatory Affairs for Pharma Professional written by Dr. Jayesh Dhalani and published by Lulu.com. This book was released on with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 1000440516
Total Pages : 806 pages
Book Rating : 4.15/5 ( download)

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Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

Author : Vandana B. Patravale
Publisher : CRC Press
ISBN 13 : 1498730787
Total Pages : 433 pages
Book Rating : 4.85/5 ( download)

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Download or read book Pharmaceutical Product Development written by Vandana B. Patravale and published by CRC Press. This book was released on 2016-05-25 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.