Dosage Forms Formulation Developments And Regulations

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Dosage Forms Formulation Developments And Regulations

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Author : Amit Kumar Nayak
language : en
Publisher: Elsevier
Release Date : 2023-12-09

Dosage Forms Formulation Developments And Regulations written by Amit Kumar Nayak and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-12-09 with Medical categories.

Dosage Forms, Formulation Developments and Regulations, Volume One in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics, with an original approach focused on technology, novelties and future trends in the field. The book discusses the most recent developments in pharmaceutical preformulation and formulation studies, biopharmaceutics and novel pharmaceutical formulations, regulatory affairs, and good manufacturing practices. Exciting areas such as formulation strategies, optimization techniques, the biopharmaceutical classification system, and pharmaceutical aerosols are included. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This is an essential reference for researchers in academia and industry as well as advanced graduate students in pharmaceutics. - Examines trends and recent technologies in dosage, formulation and regulation - Contains contributions from leading experts in academia, research, industry and regulatory agencies - Includes high-quality illustrations, flow charts and tables for easy understanding of concepts - Discusses practical examples and research case studies

Pharmaceutical Dosage Forms And Drug Delivery Second Edition

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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.

Innovative Dosage Forms

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Author : Yogeshwar Bachhav
language : en
Publisher: John Wiley & Sons
Release Date : 2019-08-20

Innovative Dosage Forms written by Yogeshwar Bachhav and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-20 with Science categories.

Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.

Theory And Practice Of Contemporary Pharmaceutics

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Author : Tapash K. Ghosh
language : en
Publisher: CRC Press
Release Date : 2004-11-23

Theory And Practice Of Contemporary Pharmaceutics written by Tapash K. Ghosh and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-11-23 with Medical categories.

With a shift toward problem-based learning and critical thinking in many health science fields, professional pharmacy training faces a shift in focus as well. Although the Accreditation Council for Pharmacy Education (ACPE) has recently suggested guidelines for problem solving to be better integrated into pharmacy curriculum, pharmacy books currently available either address this material inadequately or lack it completely. Theory and Practice of Contemporary Pharmaceutics addresses this problem by challenging pharmacy students to think critically in preparation for situations that arise in clinical practice. This book offers a wealth of up-to-date information, organized in a logical sequence, corresponding to the art and science required for formulators in industry and dispensing pharmacists in the community. It breaks down the subject to its simplest form and includes numerous examples, case studies, and problems. In addition to presenting basic scientific principles, each chapter includes a self-evaluation tutorial designed to help you evaluate your understanding of the subject matter, numerical problems that provide practice in finding mathematical solutions, and case studies that measure your overall grasp of the subject matter by challenging you to craft a plausible solution to a real-life scenario using the concepts presented in that chapter. Written by authors selected from academia, industry, and regulatory agencies, the book presents an objective and balanced view of pharmaceutical science and its application. The authors' insights are extremely helpful to pharmacy students as well as practicing pharmacists involved in the development and/or dispensation of existing and new generation biotechnology-based drug products. This simplified and user-friendly book will present pharmaceutics in a way that it has never been presented before and will help prepare students and pharmacists for the competitive and challenging nature of the professional market.

Pharmaceutical Preformulation And Formulation

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Author : Mark Gibson
language : en
Publisher: CRC Press
Release Date : 2016-04-19

Pharmaceutical Preformulation And Formulation written by Mark Gibson and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.

Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the ne

The Challenge Of Cmc Regulatory Compliance For Biopharmaceuticals

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Author : John Geigert
language : en
Publisher: Springer Nature
Release Date : 2023-06-15

The Challenge Of Cmc Regulatory Compliance For Biopharmaceuticals written by John Geigert and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-06-15 with Science categories.

Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.

Pharmaceutical Product Development

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Author : Mr. Rohit Manglik
language : en
Publisher: EduGorilla Publication
Release Date : 2024-04-06

Pharmaceutical Product Development written by Mr. Rohit Manglik and has been published by EduGorilla Publication this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-04-06 with Medical categories.

EduGorilla Publication is a trusted name in the education sector, committed to empowering learners with high-quality study materials and resources. Specializing in competitive exams and academic support, EduGorilla provides comprehensive and well-structured content tailored to meet the needs of students across various streams and levels.

Pharmaceutical Product Development

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Author : Chilukuri Dakshina Murthy
language : en
Publisher: CRC Press
Release Date : 2007-02-12

Pharmaceutical Product Development written by Chilukuri Dakshina Murthy and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-02-12 with Medical categories.

During the last two decades, the pharmaceutical industry has been under pressure to reduce development costs and the time needed to bring drugs to market in order to maximize return on investment and bring treatments to patients sooner. To meet these ends, pharmaceutical scientists working in the differing areas of pharmacy, pharmaceutics, and phar

Pharmaceutical Manufacturing Formulations

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Author : Dr. Priyanka Gupta Manglik
language : en
Publisher: EduGorilla Publication
Release Date : 2024-08-15

Pharmaceutical Manufacturing Formulations written by Dr. Priyanka Gupta Manglik and has been published by EduGorilla Publication this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-08-15 with Medical categories.

This book provides detailed insight into the various aspects of pharmaceutical manufacturing, covering formulations, process design, technology, and regulatory requirements, essential for professionals in the pharma industry.

Handbook Of Pharmaceutical Manufacturing Formulations

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Author : Sarfaraz K. Niazi
language : en
Publisher: CRC Press
Release Date : 2016-04-19

Handbook Of Pharmaceutical Manufacturing Formulations written by Sarfaraz K. Niazi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.

Providing methodologies that can serve as a reference point for new formulations, the second volume covers uncompressed solids, which include formulations of powders, capsules, powders ready for reconstitution, and other similar products.Highlights from Uncompressed Solid Products, Volume Two include:the fundamental issues of good manufacturin