Computer Applications In Pharmaceutical Research And Development

Author: Sean Ekins
Editor: John Wiley & Sons
ISBN: 0470037229
File Size: 65,36 MB
Format: PDF, ePub
Read: 4717
Download

A unique, holistic approach covering all functions and phases of pharmaceutical research and development While there are a number of texts dedicated to individual aspects of pharmaceutical research and development, this unique contributed work takes a holistic and integrative approach to the use of computers in all phases of drug discovery, development, and marketing. It explains how applications are used at various stages, including bioinformatics, data mining, predicting human response to drugs, and high-throughput screening. By providing a comprehensive view, the book offers readers a unique framework and systems perspective from which they can devise strategies to thoroughly exploit the use of computers in their organizations during all phases of the discovery and development process. Chapters are organized into the following sections: * Computers in pharmaceutical research and development: a general overview * Understanding diseases: mining complex systems for knowledge * Scientific information handling and enhancing productivity * Computers in drug discovery * Computers in preclinical development * Computers in development decision making, economics, and market analysis * Computers in clinical development * Future applications and future development Each chapter is written by one or more leading experts in the field and carefully edited to ensure a consistent structure and approach throughout the book. Figures are used extensively to illustrate complex concepts and multifaceted processes. References are provided in each chapter to enable readers to continue investigating a particular topic in depth. Finally, tables of software resources are provided in many of the chapters. This is essential reading for IT professionals and scientists in the pharmaceutical industry as well as researchers involved in informatics and ADMET, drug discovery, and technology development. The book's cross-functional, all-phases approach provides a unique opportunity for a holistic analysis and assessment of computer applications in pharmaceutics.

Pharmaceutical Excipients

Author: Otilia M. Y. Koo
Editor: John Wiley & Sons
ISBN: 111814564X
File Size: 76,56 MB
Format: PDF, Kindle
Read: 8153
Download

Featuring methodology, applications, and up-to-date advances through the perspectives of developers, users, and regulatory personnel,Pharmaceutical Excipients provides an overview of excipients, functionalities of excipients in pharmaceutical dosage forms, case studies, and how their selection can influence pharmaceutical products manufacture. Including up-to-date advancements of their use in the field, this valuable resource for scientists, researchers, and chemical engineers compiles ten detailed chapters that encompass the overview, applications, and most current research.

Bayesian Applications In Pharmaceutical Development

Author: Mani Lakshminarayanan
Editor: CRC Press
ISBN: 1351584162
File Size: 67,77 MB
Format: PDF, Mobi
Read: 6641
Download

The cost for bringing new medicine from discovery to market has nearly doubled in the last decade and has now reached $2.6 billion. There is an urgent need to make drug development less time-consuming and less costly. Innovative trial designs/ analyses such as the Bayesian approach are essential to meet this need. This book will be the first to provide comprehensive coverage of Bayesian applications across the span of drug development, from discovery, to clinical trial, to manufacturing with practical examples. This book will have a wide appeal to statisticians, scientists, and physicians working in drug development who are motivated to accelerate and streamline the drug development process, as well as students who aspire to work in this field. The advantages of this book are: Provides motivating, worked, practical case examples with easy to grasp models, technical details, and computational codes to run the analyses Balances practical examples with best practices on trial simulation and reporting, as well as regulatory perspectives Chapters written by authors who are individual contributors in their respective topics Dr. Mani Lakshminarayanan is a researcher and statistical consultant with more than 30 years of experience in the pharmaceutical industry. He has published over 50 articles, technical reports, and book chapters besides serving as a referee for several journals. He has a PhD in Statistics from Southern Methodist University, Dallas, Texas and is a Fellow of the American Statistical Association. Dr. Fanni Natanegara has over 15 years of pharmaceutical experience and is currently Principal Research Scientist and Group Leader for the Early Phase Neuroscience Statistics team at Eli Lilly and Company. She played a key role in the Advanced Analytics team to provide Bayesian education and statistical consultation at Eli Lilly. Dr. Natanegara is the chair of the cross industry-regulatory-academic DIA BSWG to ensure that Bayesian methods are appropriately utilized for design and analysis throughout the drug-development process.

Biopharmaceutics Applications In Drug Development

Author: Rajesh Krishna
Editor: Springer Science & Business Media
ISBN: 038772379X
File Size: 23,76 MB
Format: PDF, ePub, Docs
Read: 7184
Download

The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.

The Future Of Pharmaceutical Product Development And Research

Author:
Editor: Academic Press
ISBN: 0128144556
File Size: 31,59 MB
Format: PDF
Read: 7153
Download

The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. Provides an overview of practical information for clinical trials Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) Examines recent developments and suggests future directions for drug production methods and techniques

New Scientist

Author:
Editor:
ISBN:
File Size: 70,16 MB
Format: PDF
Read: 303
Download

New Scientist magazine was launched in 1956 "for all those men and women who are interested in scientific discovery, and in its industrial, commercial and social consequences". The brand's mission is no different today - for its consumers, New Scientist reports, explores and interprets the results of human endeavour set in the context of society and culture.

Modern Pharmaceutics Applications And Advances

Author: Alexander Taylor Florence
Editor: Informa Healthcare
ISBN: 9781420065640
File Size: 71,13 MB
Format: PDF, Docs
Read: 9038
Download


Pharmaceutical Quality By Design

Author: Walkiria S. Schlindwein
Editor: John Wiley & Sons
ISBN: 1118895207
File Size: 59,96 MB
Format: PDF
Read: 5364
Download

A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Pharmaceutical Biotechnology

Author: Daan J. A. Crommelin
Editor: Springer Science & Business Media
ISBN: 1461464862
File Size: 37,98 MB
Format: PDF, Kindle
Read: 5940
Download

This introductory text explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry. The Fourth Edition will completely update the previous edition, and will also include additional coverage on the newer approaches such as oligonucleotides, siRNA, gene therapy and nanotech.

Pharmaceutical Quality By Design

Author: Sarwar Beg
Editor: Academic Press
ISBN: 0128163720
File Size: 39,18 MB
Format: PDF, Kindle
Read: 1865
Download

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Computer Applications In Pharmaceutical Science

Author: S. L. Lim
Editor:
ISBN: 9781645321095
File Size: 50,25 MB
Format: PDF, ePub, Mobi
Read: 4263
Download

Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with emphasis of their application in process control, neural computing. It explains how applications are used at various stages. The book offers readers a unique framework and systems perspective from which they can devise strategies to thoroughly exploit the use of computers in their organizations during all phases of the discovery and development process. This is essential reading for IT professionals and scientists in the pharmaceutical industry as well as researchers involved in informatics. The book's cross-functional, all-phases approach provides a unique opportunity for a holistic analysis and assessment of computer applications in pharmaceutics.

New Scientist

Author:
Editor:
ISBN:
File Size: 36,38 MB
Format: PDF, ePub, Mobi
Read: 7335
Download

New Scientist magazine was launched in 1956 "for all those men and women who are interested in scientific discovery, and in its industrial, commercial and social consequences". The brand's mission is no different today - for its consumers, New Scientist reports, explores and interprets the results of human endeavour set in the context of society and culture.

New Scientist

Author:
Editor:
ISBN:
File Size: 75,38 MB
Format: PDF, Kindle
Read: 1102
Download

New Scientist magazine was launched in 1956 "for all those men and women who are interested in scientific discovery, and in its industrial, commercial and social consequences". The brand's mission is no different today - for its consumers, New Scientist reports, explores and interprets the results of human endeavour set in the context of society and culture.

Pharmaceutical Biotechnology

Author: Oliver Kayser
Editor: John Wiley & Sons
ISBN: 3527329943
File Size: 28,70 MB
Format: PDF, ePub
Read: 4006
Download

This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.

American Journal Of Hospital Pharmacy

Author:
Editor:
ISBN:
File Size: 53,22 MB
Format: PDF, Docs
Read: 2952
Download


Applications Of Polymers In Drug Delivery

Author: Ambikanandan Misra
Editor: Smithers Rapra
ISBN: 1847358535
File Size: 79,96 MB
Format: PDF, ePub, Mobi
Read: 8819
Download

Use of polymers has become indispensable in the field of drug delivery. Polymers play a crucial role in modulating drug delivery to exploit maximum therapeutic benefits and have been fundamental in the successful development of several novel drug delivery systems that are now available. This book provides details of the applications of polymeric drug delivery systems that will be of interest to researchers in industries and academia. It describes the development of polymeric systems ranging from the conventional dosage forms up to the most recent smart systems. The regulatory and intellectual property aspects as well as the clinical applicability of polymeric drug delivery systems are also discussed.Each different drug delivery route is discussed in a separate chapter of the book. All major routes of drug delivery have been covered to provide the reader with a panoramic as well as an in-depth view of the developments in polymer-based drug delivery systems. Appendices are included which incorporate useful pharmaceutical properties of the polymers and important polymeric applications for various drug delivery routes.

Developing Solid Oral Dosage Forms

Author: Yihong Qiu
Editor: Academic Press
ISBN: 0128026375
File Size: 67,96 MB
Format: PDF, ePub, Mobi
Read: 6743
Download

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

Tablet Machine Instrumentation In Pharmaceutics

Author: Peter Ridgway Watt
Editor: Ellis Horwood
ISBN: 9780470210888
File Size: 16,56 MB
Format: PDF, ePub, Docs
Read: 2992
Download


The Role Of Microstructure In Topical Drug Product Development

Author: Nigel Langley
Editor: Springer
ISBN: 3030173550
File Size: 22,34 MB
Format: PDF, Kindle
Read: 2619
Download

Following the Semi-solid Microstructure Workshop sponsored by BASF and hosted by the Rutgers Center for Dermal Research, a pharmaceutical product development working group was formed. The group, known as the Q3 Working Group, selected the following five areas of focus: Particle/Globule Size and Distribution, Viscosity/Rheology/Spreadability, In Vitro Testing, State of API, State of Excipients. A committee was appointed for each of these five areas. The committees were tasked to review the literature, identify best practices, list experimental details required for an independent lab to duplicate the test, and propose scientific studies that may meaningfully advance this specific area of focus. Each committee has a chair (or co-chairs) that are the lead author(s) of the chapter. The Q3 Working Group members serve as the critical reviewers of each chapter, making suggestions that improve the quality of the document and that make each of the five chapters uniform in scope and content.Pharmaceutical development scientists that formulate topical products (creams, lotions, gels suspensions, foams, etc) and all the allied raw material suppliers, packaging suppliers, contract laboratories including CROs, CMOs and regulators need access to this book. Overall, the topic of semisolid microstructure is of equal importance to the generic pharmaceutical companies (filing Abbreviated New Drug Applications or ANDAs) and pharmaceutical companies filing New Drug Applications (NDAs). In addition to products applied to the skin, hair, and nails, The Role of Microstructure in Topical Drug Product Development’ crosses over and is essential reading to developers of oral suspensions, ophthalmic ointments and gels, otic suspension, vaginal semisolids and retention enemas.