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Integrated Pharmaceutics

Integrated Pharmaceutics Author Antoine Al-Achi
ISBN-10 9780470596920
Release 2013-02-11
Pages 991
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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

Developing Solid Oral Dosage Forms Author Yihong Qiu
ISBN-10 008093272X
Release 2009-03-10
Pages 978
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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



Preformulation in Solid Dosage Form Development

Preformulation in Solid Dosage Form Development Author Moji Christianah Adeyeye
ISBN-10 9780849360862
Release 2008-01-07
Pages 616
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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



An Introduction to Botanical Medicines

An Introduction to Botanical Medicines Author Antoine Al-Achi
ISBN-10 9780313350092
Release 2008
Pages 188
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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.



The King of Torts

The King of Torts Author John Grisham
ISBN-10 9780345531995
Release 2012-01
Pages 472
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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

Oral Controlled Release Formulation Design and Drug Delivery Author Hong Wen
ISBN-10 1118060326
Release 2011-01-14
Pages 376
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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

Pharmaceutical Suspensions Author Alok K. Kulshreshtha
ISBN-10 1441910875
Release 2009-11-05
Pages 327
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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.



Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis Author Satinder Ahuja
ISBN-10 0123759811
Release 2010-11-11
Pages 598
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Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS



Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook Author Shayne Cox Gad
ISBN-10 0470259809
Release 2008-03-21
Pages 1384
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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.



WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations Author World Health Organization
ISBN-10 9789241209298
Release 2005-11-11
Pages 142
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This report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices, inspection, distribution and trade, and other aspects of quality assurance of pharmaceuticals, and regulatory issues. Several annexes include an amendment togood manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products, and draft guidelines for registration of fixed-dose combination medicinal products.



Rational Design of Stable Protein Formulations

Rational Design of Stable Protein Formulations Author John F. Carpenter
ISBN-10 9781461505570
Release 2012-12-06
Pages 206
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Recombinant proteins and polypeptides continue to be the most important class of biotechnology-derived agents in today's pharmaceutical industry. Over the past few years, our fundamental understanding of how proteins degrade and how stabilizing agents work has made it possible to approach formulation of protein pharmaceuticals from a much more rational point of view. This book describes the current level of understanding of protein instability and the strategies for stabilizing proteins under a variety of stressful conditions.



Molecular Biopharmaceutics

Molecular Biopharmaceutics Author Bente Steffansen
ISBN-10 0853697221
Release 2010
Pages 371
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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.



In Vitro In Vivo Correlations

In Vitro In Vivo Correlations Author David B. Young
ISBN-10 9781468460360
Release 2013-03-08
Pages 300
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This book represents the invited presentations and some of the posters presented at the conference entitled "In Vitro-In Vivo Relationship (IVIVR) Workshop" held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development.



Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development Author Kim Huynh-Ba
ISBN-10 9780387856278
Release 2008-11-16
Pages 389
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This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.



Making Medicines in Africa

Making Medicines in Africa Author Maureen Mackintosh
ISBN-10 9781137546470
Release 2016-02-03
Pages 334
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This book is open access under a CC-BY license. The importance of the pharmaceutical industry in Sub-Saharan Africa, its claim to policy priority, is rooted in the vast unmet health needs of the sub-continent. Making Medicines in Africa is a collective endeavour, by a group of contributors with a strong African and more broadly Southern presence, to find ways to link technological development, investment and industrial growth in pharmaceuticals to improve access to essential good quality medicines, as part of moving towards universal access to competent health care in Africa. The authors aim to shift the emphasis in international debate and initiatives towards sustained Africa-based and African-led initiatives to tackle this huge challenge. Without the technological, industrial, intellectual, organisational and research-related capabilities associated with competent pharmaceutical production, and without policies that pull the industrial sectors towards serving local health needs, the African sub-continent cannot generate the resources to tackle its populations' needs and demands. Research for this book has been selected as one of the 20 best examples of the impact of UK research on development. See http://www.ukcds.org.uk/the-global-impact-of-uk-research for further details.



Freeze Drying Lyophilization Of Pharmaceutical Biological Products Second Edition Revised and Expanded

Freeze Drying Lyophilization Of Pharmaceutical   Biological Products  Second Edition  Revised and Expanded Author Louis Rey
ISBN-10 9780203021323
Release 2004-01-21
Pages 600
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Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD® packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.



OCA Java SE 7 Programmer I Certification Guide

OCA Java SE 7 Programmer I Certification Guide Author Mala Gupta
ISBN-10 1617291048
Release 2013
Pages 528
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Summary This book is a comprehensive guide to the 1Z0-803 exam. You'll explore a wide range of important Java topics as you systematically learn how to pass the certification exam. Each chapter starts with a list of the exam objectives covered in that chapter. You'll find sample questions and exercises designed to reinforce key concepts and to prepare you for what you'll see in the real exam, along with numerous tips, notes, and visual aids throughout the book. About This Book To earn the OCA Java SE 7 Programmer Certification, you need to know your Java inside and out, and to pass the exam it's good 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 7 Programmer I Certification Guide is a comprehensive guide to the 1Z0-803 exam. You'll explore important Java topics as you systematically learn what is required. Each chapter starts with a list of exam objectives, followed by sample questions and exercises designed to reinforce key concepts. It provides multiple ways to digest important techniques and concepts, including analogies, diagrams, flowcharts, and lots of well-commented code. Written for developers with a working knowledge of Java who want to earn the OCA Java SE 7 Programmer I Certification. Purchase of the print book includes a free eBook in PDF, Kindle, and ePub formats from Manning Publications. What's Inside Covers all exam topics Hands-on coding exercises How to avoid built-in traps and pitfalls About the Author Mala Gupta has been training programmers to pass Java certification exams since 2006. She holds OCA Java SE7 Programmer I, SCWCD, and SCJP certifications. Table of Contents Introduction Java basics Working with Java data types Methods and encapsulation String, StringBuilder, Arrays, and ArrayList Flow control Working with inheritance Exception handling Full mock exam