[PDF] Integrated Pharmaceutics Applied Preformulation Product Design And Regulatory Science Download [eBook/PDF/EPUB]

Integrated Pharmaceutics

Author: Antoine Al-Achi
Publisher: John Wiley & Sons
ISBN: 0470596929
Format: PDF, Kindle
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An examination of all aspects of the science and art of dosage form development Integrating physical pharmacy, drug design, and drug regulation, this book examines all the key elements needed to produce effective dosage forms for drug delivery. It begins by setting a solid foundation of physical pharmacy principles such as drug stability estimation, rheology, and interfacial properties. Next, the authors explain how to incorporate these principles into product design. Lastly, the book integrates harmonized pharmaceutical development regulatory guidelines and requirements with the science and technology of pharmaceutical product design in the United States, European Union, and Japan. Integrated Pharmaceutics offers a comprehensive portrait of pharmaceutical product design, fully describing the science and art of dosage form development. Readers will find clear and thorough coverage of: Fundamental physical pharmacy principles and their role in drug product design Regulatory science section covering drug regulation, pharmacy compounding practices, manufacturing validation, and quality systems and controls Recent regulatory guidelines for quality by design, design space analysis, process analytical technology, polymorphism characterization, blend sample uniformity, stability protocols, and biopharmaceutical classification systems Each chapter includes a glossary defining key terms and a list of references leading to the primary literature in the field. Many of the chapters also feature case studies, reference appendices, and practical problems, enabling readers to apply the principles set forth in the book to solve common problems in drug product design. With its comprehensive, multidisciplinary approach, Integrated Pharmaceutics is recommended for graduate-level courses in pharmacy, the pharmaceutical sciences, pharmaceutics, physical pharmacy, drug formulation and design, and biomedicine. The book will also enable professionals in the pharmaceutical industry to apply an effective integrated approach to drug product design.

Developing Solid Oral Dosage Forms

Author: Yihong Qiu
Publisher: Academic Press
ISBN: 9780080932729
Format: PDF
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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

An Introduction to Botanical Medicines

Author: Antoine Al-Achi
Publisher: ABC-CLIO
ISBN: 0313350094
Format: PDF, Kindle
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This book offers the most current research and scientific evidence on the benefits and risks of botanical medicines, presented in reader-friendly language.

AMCQ ANNOTATED MULTIPLE CHOICE QUESTIONS

Author: Australian Medical Council
Publisher: John Wiley & Sons
ISBN:
Format: PDF, ePub, Docs
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The Australian Medical Council (AMC) put this book together to assist overseas-trained doctors appearing for the AMC AMCQ examination. This book is a valuable guide and self-assessment tool for this exam. It also illustrates the best-practice principles for a wide range of medical conditions found in the Australian community. All medical students will find this book an invaluable aid as an educational resource in preparation for their clinical assessments, as should postgraduate trainees preparing for higher degrees across the spectrum of general and specialist practice. The questions are representative of curricula of medical schools at universities across Australia.

The King of Torts

Author: John Grisham
Publisher: Dell Publishing Company
ISBN: 034553199X
Format: PDF, Kindle
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Washed-up public defender Clay Carter's latest case, a routine street killing, takes an unexpected turn when he discovers evidence of a conspiracy involving a large drug company and a lawsuit with a huge potential settlement. Reprint. 35,000 first printing.

Oral Controlled Release Formulation Design and Drug Delivery

Author: Hong Wen
Publisher: John Wiley & Sons
ISBN: 9781118060322
Format: PDF, ePub, Docs
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This book describes the theories, applications, and challenges for different oral controlled release formulations. This book differs from most in its focus on oral controlled release formulation design and process development. It also covers the related areas like preformulation, biopharmaceutics, in vitro-in vivo correlations (IVIVC), quality by design (QbD), and regulatory issues.

Pharmaceutical Suspensions

Author: Alok K. Kulshreshtha
Publisher: Springer Science & Business Media
ISBN: 9781441910875
Format: PDF
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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.

Molecular Biopharmaceutics

Author: Bente Steffansen
Publisher:
ISBN: 9780853697220
Format: PDF, ePub, Mobi
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This book covers a complex and developing academic scientific area. It focuses on describing the interplay between the chemistry of drug molecules and membrane transporters. It also aims to guide researchers in setting up experiments that may help in understanding the mechanisms and kinetics involved in drug absorption, transport and delivery. Starting with an introduction to the topic, Molecular Biopharmaceutics then considers the following: physico-chemical characterisation of drug candidates; membrane transport of drug candidates; describing and predicting bioavailability.

Preformulation in Solid Dosage Form Development

Author: Moji Christianah Adeyeye
Publisher: CRC Press
ISBN: 0824758099
Format: PDF, ePub, Docs
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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

Pharmaceutical Manufacturing Handbook

Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 9780470259801
Format: PDF, Kindle
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This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.