Dosage Forms Formulation Developments And Regulations

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Dosage Forms, Formulation Developments and Regulations

Amit Kumar Nayak,Kalyan Kumar Sen
Dosage Forms Formulation Developments and Regulations Book PDF

Author : Amit Kumar Nayak,Kalyan Kumar Sen
Publisher : Elsevier
Page : 759 pages
File Size : 46,5 Mb
Release : 2023-12-09
Category : Medical
ISBN : 9780323972468

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Dosage Forms, Formulation Developments and Regulations by Amit Kumar Nayak,Kalyan Kumar Sen Pdf

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

Dosage Form Design Parameters

Anonim
Dosage Form Design Parameters Book PDF

Author : Anonim
Publisher : Academic Press
Page : 810 pages
File Size : 49,6 Mb
Release : 2018-07-25
Category : Medical
ISBN : 9780128144220

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Dosage Form Design Parameters by Anonim Pdf

Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Developing Solid Oral Dosage Forms

Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
Developing Solid Oral Dosage Forms Book PDF

Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
Publisher : Academic Press
Page : 978 pages
File Size : 52,8 Mb
Release : 2009-03-10
Category : Medical
ISBN : 008093272X

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Developing Solid Oral Dosage Forms by Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter Pdf

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

Dosage Form Design Considerations

Anonim
Dosage Form Design Considerations Book PDF

Author : Anonim
Publisher : Academic Press
Page : 820 pages
File Size : 55,6 Mb
Release : 2018-07-28
Category : Medical
ISBN : 9780128144244

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Dosage Form Design Considerations by Anonim Pdf

Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Innovative Dosage Forms

Yogeshwar Bachhav
Innovative Dosage Forms Book PDF

Author : Yogeshwar Bachhav
Publisher : John Wiley & Sons
Page : 470 pages
File Size : 52,5 Mb
Release : 2019-12-04
Category : Science
ISBN : 9783527343966

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Innovative Dosage Forms by Yogeshwar Bachhav Pdf

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.

Generic Drug Product Development

Leon Shargel,Isadore Kanfer
Generic Drug Product Development Book PDF

Author : Leon Shargel,Isadore Kanfer
Publisher : CRC Press
Page : 400 pages
File Size : 41,5 Mb
Release : 2013-10-24
Category : Medical
ISBN : 9781420086355

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Generic Drug Product Development by Leon Shargel,Isadore Kanfer Pdf

In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. Major topics discussed include: Active pharmaceutical ingredients Experimental formulation development, including a new section on Quality by Design (QbD) Scale-up Commercial product formulation Quality control and bioequivalence Drug product performance ANDA regulatory process Post-approval changes Post-marketing surveillance Legislative and patent challenges This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.

How to Develop Robust Solid Oral Dosage Forms

Bhavishya Mittal
How to Develop Robust Solid Oral Dosage Forms Book PDF

Author : Bhavishya Mittal
Publisher : Academic Press
Page : 190 pages
File Size : 40,9 Mb
Release : 2016-10-05
Category : Medical
ISBN : 9780128047323

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How to Develop Robust Solid Oral Dosage Forms by Bhavishya Mittal Pdf

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

Pharmaceutical Suspensions

Alok K. Kulshreshtha,Onkar N. Singh,G. Michael Wall
Pharmaceutical Suspensions Book PDF

Author : Alok K. Kulshreshtha,Onkar N. Singh,G. Michael Wall
Publisher : Springer Science & Business Media
Page : 337 pages
File Size : 47,5 Mb
Release : 2009-11-05
Category : Medical
ISBN : 9781441910875

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Pharmaceutical Suspensions by Alok K. Kulshreshtha,Onkar N. Singh,G. Michael Wall Pdf

The suspension dosage form has long been used for poorly soluble active ingre- ents for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts. A good understanding of the fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of a s- pension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, visco- ters, particle size analyzers, etc.) must be utilized to properly characterize the s- pension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require cli- cal trials to establish the safety and efficacy of the drug product. All of this devel- ment work should culminate into a regulatory filing in accordance with the regulatory guidelines. Pharmaceutical Suspensions, From Formulation Development to Manufacturing, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system – poorly soluble active pharmaceutical ingredients s- pended in a suitable vehicle.

Pharmaceutical Formulation

Geoffrey D Tovey
Pharmaceutical Formulation Book PDF

Author : Geoffrey D Tovey
Publisher : Royal Society of Chemistry
Page : 432 pages
File Size : 47,5 Mb
Release : 2018-06-25
Category : Science
ISBN : 9781849739412

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Pharmaceutical Formulation by Geoffrey D Tovey Pdf

Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety and stability of the final medicinal product. Modern formulation science deals with biologics as well as small molecules. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field. Pharmaceutical Formulation provides an up to date source of information for all who wish to understand the principles and practice of formulation in the drug industry. The book provides an understanding of the links between formulation theory and the practicalities of processing in a commercial environment, giving researchers the knowledge to produce effective pharmaceutical products that can be approved and manufactured. The first chapters introduce readers to different dosage forms, including oral liquid products, topical products and solid dosage forms such as tablets and capsules. Subsequent chapters cover pharmaceutical coatings, controlled release drug delivery and dosage forms designed specifically for paediatric and geriatric patients. The final chapter provides an introduction to the vital role intellectual property plays in drug development. Covering modern processing methods and recent changes in the regulatory and quality demands of the industry, Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry.

Pharmaceutical Dosage Forms - Parenteral Medications

Sandeep Nema,John D. Ludwig
Pharmaceutical Dosage Forms Parenteral Medications Book PDF

Author : Sandeep Nema,John D. Ludwig
Publisher : CRC Press
Page : 328 pages
File Size : 45,9 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420086485

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Pharmaceutical Dosage Forms - Parenteral Medications by Sandeep Nema,John D. Ludwig Pdf

This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the

Formulation and Analytical Development for Low-Dose Oral Drug Products

Jack Zheng
Formulation and Analytical Development for Low Dose Oral Drug Products Book PDF

Author : Jack Zheng
Publisher : John Wiley & Sons
Page : 506 pages
File Size : 53,6 Mb
Release : 2009-02-09
Category : Medical
ISBN : 9780470056097

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Formulation and Analytical Development for Low-Dose Oral Drug Products by Jack Zheng Pdf

There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

Pharmaceutical Preformulation and Formulation

Mark Gibson
Pharmaceutical Preformulation and Formulation Book PDF

Author : Mark Gibson
Publisher : CRC Press
Page : 562 pages
File Size : 49,6 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420073188

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Pharmaceutical Preformulation and Formulation by Mark Gibson Pdf

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

Pharmaceutical Formulation Design

Usama Ahmad,Juber Akhtar
Pharmaceutical Formulation Design Book PDF

Author : Usama Ahmad,Juber Akhtar
Publisher : BoD – Books on Demand
Page : 166 pages
File Size : 55,6 Mb
Release : 2020-02-05
Category : Medical
ISBN : 9781789856620

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Pharmaceutical Formulation Design by Usama Ahmad,Juber Akhtar Pdf

Pharmaceutical formulations have evolved from simple and traditional systems to more modern and complex novel dosage forms. Formulation development is a tedious process and requires an enormous amount of effort from many different people. Developing a stable novel dosage form and further targeting it to the desired site inside the body has always been a challenge. The purpose of this book is to bring together scholarly articles that highlight recent developments and trends in pharmaceutical formulation science. Each article has been written by authors specializing in the subject area and hailing from top institutions around the world. The book has been written in a systematic and lucid style explaining all basic concepts and fundamentals in a very simple way. This book aims to serve the need of all individuals involved at any level in the pharmaceutical dosage form development. I sincerely hope that the book will be liked by inquisitive students and learned colleagues.

Integrated Pharmaceutics

Antoine Al-Achi,Mali Ram Gupta,William Craig Stagner
Integrated Pharmaceutics Book PDF

Author : Antoine Al-Achi,Mali Ram Gupta,William Craig Stagner
Publisher : John Wiley & Sons
Page : 1024 pages
File Size : 45,8 Mb
Release : 2013-01-22
Category : Medical
ISBN : 9781118356722

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Integrated Pharmaceutics by Antoine Al-Achi,Mali Ram Gupta,William Craig Stagner Pdf

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.

Pharmaceutics

Dr. Abhinandan Patil,Dr. Rajeshwar V. Kshirsagar,Dr. Firoj A. Tamboli,Dr. Ramling G. Patrakar
Pharmaceutics Book PDF

Author : Dr. Abhinandan Patil,Dr. Rajeshwar V. Kshirsagar,Dr. Firoj A. Tamboli,Dr. Ramling G. Patrakar
Publisher : Literatureslight Publishing
Page : 206 pages
File Size : 49,8 Mb
Release : 2023-08-06
Category : Medical
ISBN : 8210379456XXX

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Pharmaceutics by Dr. Abhinandan Patil,Dr. Rajeshwar V. Kshirsagar,Dr. Firoj A. Tamboli,Dr. Ramling G. Patrakar Pdf

Pharmaceutics: Design of Dosage Forms and Drug Development is a comprehensive and authoritative textbook that offers an in-depth exploration of the fundamental principles and methodologies underlying the design, development, and formulation of pharmaceutical dosage forms. Written by esteemed experts in the field, this book provides a thorough understanding of the key concepts and advancements in pharmaceutics, making it an essential resource for students, researchers, and professionals in the pharmaceutical industry.