Dosage Forms Formulation Developments And Regulations

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Dosage Form Design Parameters

Dosage Form Design Parameters
  • Author : Anonim
  • Publisher : Academic Press
  • Release Date : 2018-07-25
  • Total pages : 810
  • ISBN : 9780128144220
  • File Size : 45,6 Mb
  • Total Download : 915
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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

Developing Solid Oral Dosage Forms
  • Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
  • Publisher : Academic Press
  • Release Date : 2009-03-10
  • Total pages : 978
  • ISBN : 008093272X
  • File Size : 23,9 Mb
  • Total Download : 763
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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

Dosage Form Design Considerations
  • Author : Anonim
  • Publisher : Academic Press
  • Release Date : 2018-07-28
  • Total pages : 820
  • ISBN : 9780128144244
  • File Size : 55,9 Mb
  • Total Download : 971
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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

Generic Drug Product Development

Generic Drug Product Development
  • Author : Leon Shargel,Isadore Kanfer
  • Publisher : CRC Press
  • Release Date : 2013-10-24
  • Total pages : 400
  • ISBN : 9781420086355
  • File Size : 42,5 Mb
  • Total Download : 107
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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.

Preformulation in Solid Dosage Form Development

Preformulation in Solid Dosage Form Development
  • Author : Moji Christianah Adeyeye,Harry G. Brittain
  • Publisher : CRC Press
  • Release Date : 2008-01-07
  • Total pages : 0
  • ISBN : 0824758099
  • File Size : 44,7 Mb
  • Total Download : 658
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During the onset of any clinical trial there are many factors and variables to consider. Funding, time restraints, and regulatory agency guidelines are factors that often influence which variables will be studied, leaving other important information out of the study. Preformulation in Solid Dosage Form Development covers every topic of critical importance to the preformulation stages of drug development. Serving as a handbook or stand-alone reference, this text equips those in academia and the pharmaceutical industry with both basic and applied principles for the characterization of drugs, excipients, and products, and deals with the issues relating to predictability, identification, and product development during preformulation stages through Phase I of clinical trials. With contributions from an international panel of experts in the field, this guide: outlines an updated preformulation program for modern drug development issues that includes particle morphology, characterization, thermal analysis, and solubility methods contains rational designs for the structure of formulation studies covers the importance of preformulation design using artificial neural networks and computational prediction techniques, and examines the concepts of preliminary-preformulation discusses the typical drug-excipient interactions that could occur during the course of development and methods of characterization includes novel methods to determine the physical and chemical stability of new formulations reviews the structure, content, and format of the preformulation report examines the significance of drug substance physiochemical properties, in regulatory quality by design

How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms
  • Author : Bhavishya Mittal
  • Publisher : Academic Press
  • Release Date : 2016-10-05
  • Total pages : 190
  • ISBN : 9780128047323
  • File Size : 40,7 Mb
  • Total Download : 736
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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
  • Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
  • Publisher : Academic Press
  • Release Date : 2016-11-08
  • Total pages : 1176
  • ISBN : 9780128026373
  • File Size : 41,5 Mb
  • Total Download : 398
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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

Innovative Dosage Forms

Innovative Dosage Forms
  • Author : Yogeshwar Bachhav
  • Publisher : John Wiley & Sons
  • Release Date : 2019-08-09
  • Total pages : 352
  • ISBN : 9783527812202
  • File Size : 26,6 Mb
  • Total Download : 377
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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.

Pharmaceutical Formulation

Pharmaceutical Formulation
  • Author : Geoffrey D Tovey
  • Publisher : Royal Society of Chemistry
  • Release Date : 2018-06-25
  • Total pages : 409
  • ISBN : 9781788014434
  • File Size : 19,7 Mb
  • Total Download : 566
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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 Suspensions

Pharmaceutical Suspensions
  • Author : Alok K. Kulshreshtha,Onkar N. Singh,G. Michael Wall
  • Publisher : Springer Science & Business Media
  • Release Date : 2009-11-05
  • Total pages : 328
  • ISBN : 9781441910875
  • File Size : 25,5 Mb
  • Total Download : 495
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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 Dosage Forms - Parenteral Medications

Pharmaceutical Dosage Forms - Parenteral Medications
  • Author : Sandeep Nema,John D. Ludwig
  • Publisher : CRC Press
  • Release Date : 2016-04-19
  • Total pages : 406
  • ISBN : 9781420086461
  • File Size : 21,7 Mb
  • Total Download : 277
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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 pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations. Volume two presents: • Chapters on aseptic facility design, environmental monitoring, and cleanroom operations. • A comprehensive chapter on pharmaceutical water systems. • A discussion of quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing. • A detailed chapter on processing of parenteral drug products (SVPs and LVPs). • Presentations on widely used sterilization technologies – steam, gas / chemical, radiation, filtration and dry heat. • An in-depth chapter on lyophilization.

In Vitro Drug Release Testing of Special Dosage Forms

In Vitro Drug Release Testing of Special Dosage Forms
  • Author : Nikoletta Fotaki,Sandra Klein
  • Publisher : John Wiley & Sons
  • Release Date : 2019-10-10
  • Total pages : 312
  • ISBN : 9781118675779
  • File Size : 29,5 Mb
  • Total Download : 536
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Guides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at the site of application and the site of drug release. This unique book is the first to cover the field of in vitro release testing of special dosage forms in one volume. Featuring contributions from an international team of experts, it presents the state of the art of the use of in vitro drug release methodologies for assessing special dosage forms’ performances and describes the different techniques required for each one. In Vitro Drug Release Testing of Special Dosage Forms covers the in vitro release testing of: lipid based oral formulations; chewable oral drug products; injectables; drug eluting stents; inhalation products; transdermal formulations; topical formulations; vaginal and rectal delivery systems and ophthalmics. The book concludes with a look at regulatory aspects. Covers both oral and non-oral dosage forms Describes current regulatory conditions for in vitro drug release testing Features contributions from well respected global experts in dissolution testing In Vitro Drug Release Testing of Special Dosage Forms will find a place on the bookshelves of anyone working with special dosage forms, dissolution testing, drug formulation and delivery, pharmaceutics, and regulatory affairs.

Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms
  • Author : Larry L. Augsburger,Stephen W. Hoag
  • Publisher : CRC Press
  • Release Date : 2017-10-30
  • Total pages : 421
  • ISBN : 9781841849775
  • File Size : 28,5 Mb
  • Total Download : 612
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Pharmaceutical Dosage Forms: Capsules covers the development, composition, and manufacture of capsules. Despite the important role that capsules play in drug delivery and product development, few comprehensive texts on the science and technology of capsules have been available for the research and academic environments. This text addresses this gap, discussing how capsules provide unique capabilities and options for dosage form design and formulation.

Formulation and Analytical Development for Low-Dose Oral Drug Products

Formulation and Analytical Development for Low-Dose Oral Drug Products
  • Author : Jack Zheng
  • Publisher : John Wiley & Sons
  • Release Date : 2009-02-09
  • Total pages : 490
  • ISBN : 9780470056097
  • File Size : 51,9 Mb
  • Total Download : 756
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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 Formulation Design

Pharmaceutical Formulation Design
  • Author : Usama Ahmad,Juber Akhtar
  • Publisher : BoD – Books on Demand
  • Release Date : 2020-02-05
  • Total pages : 166
  • ISBN : 9781789856620
  • File Size : 37,8 Mb
  • Total Download : 546
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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.

Development and Formulation of Veterinary Dosage Forms

Development and Formulation of Veterinary Dosage Forms
  • Author : Gregory E Hardee,J D Baggot
  • Publisher : CRC Press
  • Release Date : 2021-04-30
  • Total pages : 504
  • ISBN : 9781420001860
  • File Size : 40,9 Mb
  • Total Download : 948
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Although the United States (U.S.) and the more developed nations of the remainder of the world are blessed with a variety of pharmaceuticals, feed additives, and biological products to treat, prevent, and control animal diseases, there is a healthy desire among persons involved in animal health issues to increase our animal medicine chest. The interest stems from the desire to efficiently produce food that is safe and plentiful and from the desire to have more and better government-approved products available for the prevention and treatment of diseases of dogs, cats, and horses and for an increasing variety of minor animal species. For the animal health industry, increased drug availability means broader markets, increased revenues, and an opportunity to better serve their customers. For the veterinarian, more animal health products means that he or she is better able to treat the usual and the unusual conditions, and to prevent animal disease and suffering. No doubt, we are all winners when new technology and industrial and regulatory initiatives hasten the availability of safe and effective animal health products.

Pharmaceutical Excipients

Pharmaceutical Excipients
  • Author : Otilia M. Y. Koo
  • Publisher : John Wiley & Sons
  • Release Date : 2016-10-31
  • Total pages : 356
  • ISBN : 9781118145647
  • File Size : 53,9 Mb
  • Total Download : 559
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This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients

Dosage Forms, Formulation Developments and Regulations

Dosage Forms, Formulation Developments and Regulations
  • Author : Amit Kumar Nayak,Kalyan Kumar Sen
  • Publisher : Academic Press
  • Release Date : 2023-04-01
  • Total pages : 0
  • ISBN : 0323918174
  • File Size : 21,9 Mb
  • Total Download : 719
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Dosage Forms, Formulation Developments and Regulations: Recent and Future Trends in Pharmaceutics, Volume 1 explores aspects of pharmaceutics with an original approach focused on technology, novelties and future trends in the field. The field of pharmaceutics is highly dynamic and rapidly expanding day by day, and it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This book provides practical information for conducting research in pharmaceutics. Dosage Forms, Formulation Developments and Regulations is an essential reference for researchers in academia and industry as well as advanced graduate students in pharmaceutics. This book, the first volume of Recent and Future Trends in Pharmaceutics, discusses in detail 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.

Development and Formulation of Veterinary Dosage Forms, Second Edition

Development and Formulation of Veterinary Dosage Forms, Second Edition
  • Author : Gregory E. Hardee,J. Desmond Baggo
  • Publisher : CRC Press
  • Release Date : 1998-02-25
  • Total pages : 504
  • ISBN : 0824798783
  • File Size : 49,8 Mb
  • Total Download : 217
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This up-to-the-minute Second Edition of an incomparable resource describes in detail the bases for developing dosage forms for use in animals-highlighting the data necessary to meet regulatory approval. Demonstrates the successful characterization, control, and registration of new veterinary medicines! Thoroughly rewritten and enlarged to reflect the technical advances that have occurred since the previous edition, Development and Formulation of Veterinary Dosage Forms, Second Edition discusses the reasons for dosage form selection explains the latest available technologies examines new drug therapeutics reveals up-to-date techniques and applications for pharmacokinetic data covers the formulation of products derived from biotechnology elucidates recent analytical methods shows how to determine the type of dosage form appropriate for particular species and more! Written by a team of international authorities from North America and Europe and containing over 1100 bibliographic citation, figures, and tables, Development and Formulation of Veterinary Dosage Forms, Second Edition is an essential reference for pharmaceutical, animal, and quality control scientists; research pharmacists and pharmacologists; veterinarians; drug quality assurance and regulatory personnel in government and industry; pathologists; microbiologists; virologists; physiologists; toxicologists; and upper-level undergraduate and graduate students in these disciplines.

Pharmaceutical Dosage Forms - Tablets

Pharmaceutical Dosage Forms - Tablets
  • Author : Larry L. Augsburger,Stephen W. Hoag
  • Publisher : CRC Press
  • Release Date : 2016-04-19
  • Total pages : 1552
  • ISBN : 9781420063868
  • File Size : 16,6 Mb
  • Total Download : 598
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The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients. Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive resource of the design, formulation, manufacture, and evaluation of the tablet dosage form, an

Pharmaceutical Preformulation and Formulation

Pharmaceutical Preformulation and Formulation
  • Author : Mark Gibson
  • Publisher : CRC Press
  • Release Date : 2016-04-19
  • Total pages : 560
  • ISBN : 9781420073188
  • File Size : 42,5 Mb
  • Total Download : 221
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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 need for advanced information for drug preformulation and formulation and addresses the current trends in the continually evolving pharmaceutical industry. Topics include: Candidate drug selection Drug discovery and development Preformulation predictions and drug selections Product design to commercial dosage form Biopharmaceutical support in formulation Development The book is ideal for practitioners working in the pharmaceutical arena—including R&D scientists, technicians, and managers—as well as for undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology.