Developing Solid Oral Dosage Forms

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Developing Solid Oral Dosage Forms


Developing Solid Oral Dosage Forms
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Developing Solid Oral Dosage Forms


Developing Solid Oral Dosage Forms
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File Size : 41,9 Mb
Total Download : 631

Author : Yihong Qiu
language : en
Publisher: Academic Press
Release Date : 2016-11-08



Developing Solid Oral Dosage Forms written by Yihong Qiu and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-08 with Medical categories.


Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

How To Develop Robust Solid Oral Dosage Forms


How To Develop Robust Solid Oral Dosage Forms
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File Size : 43,9 Mb
Total Download : 511

Author : Bhavishya Mittal
language : en
Publisher: Academic Press
Release Date : 2016-10-05



How To Develop Robust Solid Oral Dosage Forms written by Bhavishya Mittal and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-10-05 with Medical categories.


How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues

Developing Solid Oral Dosage Forms


Developing Solid Oral Dosage Forms
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File Size : 40,6 Mb
Total Download : 955

Author : Yihong Qiu
language : en
Publisher: Academic Press
Release Date : 2009-03-10



Developing Solid Oral Dosage Forms written by Yihong Qiu and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-03-10 with Medical categories.


Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

Fda Quality Standards For Generic Drug Products


Fda Quality Standards For Generic Drug Products
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File Size : 51,8 Mb
Total Download : 313

Author : Susan M. Rosencrance
language : en
Publisher: Academic Press
Release Date : 2018-03-01



Fda Quality Standards For Generic Drug Products written by Susan M. Rosencrance and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-01 with Medical categories.


FDA Quality Standards for Generic Drug Products features the history and evolution of the FDA’s generic drug program, along with an overview of the quality assessment process performed by the FDA and an in-depth look at quality standards for a variety of dosage forms. Chapters cover important topics such as quality by design, the ANDA structure, CMC, process analytical technology and other emerging technologies, design of experiments and statistics and the similarities and differences between the FDA and international regulatory agencies. Edited and written by experienced leaders in the field, this book contains case studies throughout and provides insider perspectives on what the future may hold for generic drugs. An essential resource for pharmaceutical, regulatory and academic scientists, this book can be used to establish the necessary procedures and specifications in order to seek approval to develop quality products more quickly and easily. Highlights recent developments regarding quality by design and quality standards associated with particular dosage forms, including complex generic drug products Offers an overview of the FDA’s current assessment process for ANDAs, from filing to approval, and discuses important considerations regarding post-approval changes and lifecycle management Written by FDA scientists who actively review ANDAs and develop regulatory policies associated with generic drugs

Fixed Dose Combinations For Solid Oral Drug Delivery


Fixed Dose Combinations For Solid Oral Drug Delivery
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File Size : 46,7 Mb
Total Download : 561

Author : Ali R. Rajabi-Siahboomi
language : en
Publisher: Wiley
Release Date : 2018-02-05



Fixed Dose Combinations For Solid Oral Drug Delivery written by Ali R. Rajabi-Siahboomi and has been published by Wiley this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-02-05 with Medical categories.


Outlining the steps for developing fixed dose combination (FDC) drugs, this book gives a systematic approach to the full scope of FDCs – concept, design, formulation, and commercialization. • Includes case studies to illustrate best practices and challenges • Deals with a growing part of the pharmaceutical industry, as FDCs are ideal for targeting many chronic illnesses and for reducing the number of medications an increasingly-aging population needs to take • Ensures consistency in the delivery of FDC medication, which can be pivotal in increasing patient compliance and quality of life • Collects dispersed knowledge – from patents in addition to scientific and clinical literature – so researchers can access a single source reference • Covers regulatory guidelines from around the world and looks ahead at developing areas of personalized medicine for FDCs

Pharmaceutical Dosage Forms And Drug Delivery Third Edition


Pharmaceutical Dosage Forms And Drug Delivery Third Edition
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File Size : 51,9 Mb
Total Download : 437

Author : Ram I. Mahato
language : en
Publisher: CRC Press
Release Date : 2017-11-22



Pharmaceutical Dosage Forms And Drug Delivery Third Edition written by Ram I. Mahato and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-22 with Medical categories.


Completely revised and updated, this third edition of Pharmaceutical Dosage Forms and Drug Delivery elucidates the basic principles of pharmaceutics, biopharmaceutics, dosage form design, and drug delivery – including emerging new biotechnology-based treatment modalities. The authors integrate aspects of physical pharmacy, chemistry, biology, and biopharmaceutics into drug delivery.? This book highlights the increased attention that the recent spectacular advances in gene therapy and nanotechnology have brought to dosage form design and drug delivery. With the expiration of older patents and generic competition, the biopharmaceutical industry is evolving faster than ever. Apart from revising and updating existing chapters on the basic principles, this edition highlights the emerging emphasis on drug discovery, antibodies and antibody-drug conjugates as therapeutic moieties, individualized medicine including patient stratification strategies, targeted drug delivery, and the increasing role of modeling and simulation. Although there are numerous books on pharmaceutics and dosage forms, most cover different areas of the discipline and do not provide an integrated approach. The integrated approach of this book not only provides a singular perspective of the overall field, but also supplies a unified source of information for students, instructors and professionals, saving their time and money.

Pharmaceutical Dosage Forms And Drug Delivery Second Edition


Pharmaceutical Dosage Forms And Drug Delivery Second Edition
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File Size : 41,5 Mb
Total Download : 853

Author : Ram I. Mahato
language : en
Publisher: CRC Press
Release Date : 2011-10-25



Pharmaceutical Dosage Forms And Drug Delivery Second Edition written by Ram I. Mahato and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-25 with Medical categories.


In the second edition of Pharmaceutical Dosage Forms and Drug Delivery the authors integrate aspects of physical pharmacy, biopharmaceuticals, drug delivery, and biotechnology, emphasizing the increased attention that the recent spectacular advances in dosage form design and drug delivery, gene therapy, and nanotechnology have brought to the field. Highlights of the Second Edition: Additional author Ajit S. Narang brings an industrial practitioner perspective with increased focus on pharmacy math and statistics, and powders and granules Reorganized into three parts: Introduction, Physicochemical Principles, and Dosage Forms Chapters on pharmaceutical calculations, compounding principles, and powders and granules provide a complete spectrum of application of pharmaceutical principles Expansion of review questions and answers clarifies concepts for students and adds to their grasp of key concepts covered in the chapter Coverage of complexation and protein binding aspects of physical pharmacy includes the basic concepts as well as recent progress in the field Although there are numerous books on the science of pharmaceutics and dosage form design, most cover different areas of the discipline and do not provide an integrated approach to the topics. This book not only provides a singular perspective of the overall field, but it supplies a unified source of information for students, instructors, and professionals.