[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, Docs
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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, ePub, Docs
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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 History Science Uses and Dangers

Author: Antoine Al-Achi
Publisher: ABC-CLIO
ISBN: 0313350108
Format: PDF
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For those who want to make educated decisions about whether, and when, to use natural products, this text explains the most current scientific evidence of the roles that plants can play in our health: how they can prevent, modify, or treat disease. Since antiquity, humans have used botanicals to treat various conditions affecting their organ systems, and this book is built around explaining which plants may be used for major ailments affecting the various systems. The increasing availability of botanicals on the market, intended to be used as dietary supplements for health, has been fueled by the public's demand for a more natural approach to healthcare. Unfortunately, much of the information fed to the public on alternatives is based on anecdotal evidence (case stories), the advice of friends, or media features that often do not stand up to standards for scientific evidence. In this book Al-Achi explains current research and science that exists - or remains lacking - for the various botanicals as healthcare products. He also details the potential misuse and the dangers of some herbal formulas. Photographs of 62 medicinal plants are included. For those who want to make educated decisions whether, and when, to use natural products, this text explains the most current scientific evidence of the roles that plants can play in our health: how they can prevent, modify, or treat disease. Since antiquity, humans have used botanicals to treat various conditions affecting their organ systems, and this book is built around explaining which plants may be used for major ailments affecting the various systems. The increasing availability of botanicals on the market, intended to be used as dietary supplements for health, has been fueled by the public's demand for a more natural approach to healthcare. Unfortunately, much of the information fed to the public on alternatives is based on anecdotal evidence (case studies), the advice of friends, or media features that often do not stand up to standards for scientific evidence. In this book, Al-Achi explains current research and science that exists - or remains lacking - for the various botanicals as healthcare products. He also details the potential misuse and the dangers of some herbal formulas. Photographs of 62 medicinal plants are included. Because of its evidentiary approach, this book may serve also as a text for introductory college courses in the field of botanical medicine, or as a supplemental general text for an alternative and complementary medicine course. The history leading to the use of botanicals in healthcare is described, as are botanicals used in the treatment of cancer, cardiovascular disease, endocrine system disorders such as diabetes, gastrointestinal problems, men's and women's specific disorders, infections, chronic pain, psychological disorders such as anxiety and depression, and other health issues.

The King of Torts

Author: John Grisham
Publisher: Dell Publishing Company
ISBN: 034553199X
Format: PDF, ePub
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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.

Solvent Systems and Their Selection in Pharmaceutics and Biopharmaceutics

Author: Patrick Augustijns
Publisher: Springer Science & Business Media
ISBN: 0387691545
Format: PDF, ePub, Mobi
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Solvent systems are integral to drug development and pharmaceutical technology. This single topic encompasses numerous allied subjects running the gamut from recrystallization solvents to biorelevant media. The goal of this contribution to the AAPS Biotechnology: Pharmaceutical Aspects series is to generate both a practical handbook as well as a reference allowing the reader to make effective decisions concerning the use of solvents and solvent systems. To this end, the monograph was created by inviting recognized experts from a number of fields to author relevant sections. Specifically, 15 chapters have been designed covering the theoretical background of solubility, the effect of ionic equilibria and pH on solubilization, the use of solvents to effect drug substance crystallization and polymorph selection, the use of solvent systems in high throughput screening and early discovery, solvent use in preformulation, the use of solvents in bio-relevant dissolution and permeation experiments, solvents and their use as toxicology vehicles, solubilizing media and excipients in oral and parenteral formulation development, specialized vehicles for protein formulation and solvent systems for topical and pulmonary drug administration. The chapters are organized such that useful decision trees are included together with the scientific underpinning for their application. In addition, trends in the use of solvent systems and a balance of current views make this monograph useful to both the novice and experienced researcher and to scientists at all developmental stages from early discovery to late pharmaceutical operations.

Preformulation in Solid Dosage Form Development

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

Computer Aided Drug Design and Delivery Systems

Author: Ahindra Nag
Publisher: McGraw Hill Professional
ISBN: 0071701257
Format: PDF, ePub, Mobi
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THE LATEST BREAKTHROUGHS IN COMPUTER-AIDED DRUG DESIGN AND DELIVERY This definitive text provides in-depth information on computer-assisted techniques for discovering, designing, and optimizing new, effective, and safe drugs. Computer-Aided Drug Design and Delivery Systems offers objective and quantitative data on the use and delivery of drugs in humans. Enabling technologies such as bioinformatics, pharmacokinetics, biosensors, robotics, and bioinstruments are thoroughly discussed in this innovative work. Coverage includes: Computer-aided drug design (CADD) Drug delivery systems Bioinformatics of drug molecules and databases Lipase- and esterase-mediated drugs and drug intermediates Pharmacokinetics and pharmacodynamics of drugs Biomarkers, biosensors, and robotics in medicine Biomedical instrumentation

The Textbook of Pharmaceutical Medicine

Author: John P. Griffin
Publisher: John Wiley & Sons
ISBN: 111853235X
Format: PDF, Mobi
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The Textbook of Pharmaceutical Medicine is the standard reference for everyone working and learning in pharmaceutical medicine. It is a comprehensive resource covering the processes and practices by which medicines are developed, tested and approved, and the recognised text for the Diploma in Pharmaceutical Medicine from the Faculty of Pharmaceutical Medicine. This fully revised Seventh Edition, which includes two new Editors, encompasses current developments within pharmaceutical medicine with new chapters on biological therapeutics, pharmacovigilance, vaccines, drugs for cancer, drug development in paediatrics and neonatalogy, the clinical trials directive, life cycle management of medicines, counterfeit medicines and medical marketing. Also included for easy reference, and referred to throughout the text, are the Declaration of Helsinki, Guidelines and Documentation for Implementation of Clinical Trials, relevant European Directives and the Syllabus for Pharmaceutical Medicine. Written by an international team of leading academics, medical directors and lawyers, The Textbook of Pharmaceutical Medicine, Seventh Edition meets the needs of both those working in pharmaceutical medicine and preparing for the Diploma in Pharmaceutical Medicine. The text breaks down into three core sections: Part I: Research and Development Part II: Regulation Part III: Healthcare marketplace View Table of Contents in detail

OCA Java SE 8 Programmer I Certification Guide

Author: Mala Gupta
Publisher: Manning Publications
ISBN: 9781617293252
Format: PDF, ePub
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Summary OCA Java SE 8 Programmer I Certification Guide prepares you for the 1Z0-808 with complete coverage of the exam. You'll explore important Java topics as you systematically learn what's required to successfully pass the test. Purchase of the print book includes a free eBook in PDF, Kindle, and ePub formats from Manning Publications. About the Book To earn the OCA Java SE 8 Programmer I Certification, you have to know your Java inside and out, and to pass the exam you need to understand the test itself. This book cracks open the questions, exercises, and expectations you'll face on the OCA exam so you'll be ready and confident on test day. OCA Java SE 8 Programmer I Certification Guide prepares Java developers for the 1Z0-808 with thorough coverage of Java topics typically found on the exam. Each chapter starts with a list of exam objectives mapped to section numbers, followed by sample questions and exercises that reinforce key concepts. You'll learn techniques and concepts in multiple ways, including memorable analogies, diagrams, flowcharts, and lots of well-commented code. You'll also get the scoop on common exam mistakes and ways to avoid traps and pitfalls. What's Inside Covers all exam topics Hands-on coding exercises Flowcharts, UML diagrams, and other visual aids How to avoid built-in traps and pitfalls Complete coverage of the OCA Java SE 8 Programmer I exam (1Z0-808) About the Reader Written for developers with a working knowledge of Java who want to earn the OCA Java SE 8 Programmer I Certification. About the Author Mala Gupta is a Java coach and trainer who holds multiple Java certifications. Since 2006 she has been actively supporting Java certification as a path to career advancement. Table of Contents Introduction Java basics Working with Java data types Methods and encapsulation Selected classes from the Java API and arrays Flow control Working with inheritance Exception handling Full mock exam

Generic Drug Product Development

Author: Leon Shargel
Publisher: CRC Press
ISBN: 1420086367
Format: PDF, Kindle
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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.