The Art Of Pharmaceutical Manufacturing

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Continuous Manufacturing for the Modernization of Pharmaceutical Production

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309487811
Total Pages : 69 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Continuous Manufacturing for the Modernization of Pharmaceutical Production by : National Academies of Sciences, Engineering, and Medicine

Download or read book Continuous Manufacturing for the Modernization of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-04-05 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.

Pharmaceutical Manufacturing Handbook

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470259809
Total Pages : 1386 pages
Book Rating : 4.4/5 (72 download)

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Book Synopsis Pharmaceutical Manufacturing Handbook by : Shayne Cox Gad

Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-11 with total page 1386 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Handbook of Pharmaceutical Manufacturing Formulations

Author : Safaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1420081314
Total Pages : 458 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Handbook of Pharmaceutical Manufacturing Formulations by : Safaraz K. Niazi

Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Safaraz K. Niazi and published by CRC Press. This book was released on 2016-04-19 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster

Pharmaceutical Operations Management

Author : Pankaj Mohan
Publisher : McGraw-Hill Professional
ISBN 13 : 0071472495
Total Pages : 264 pages
Book Rating : 4.0/5 (714 download)

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Book Synopsis Pharmaceutical Operations Management by : Pankaj Mohan

Download or read book Pharmaceutical Operations Management written by Pankaj Mohan and published by McGraw-Hill Professional. This book was released on 2006-03-16 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. This book brings together a winning team of international operations experts to set the framework for building a world-class manufacturing organization. Pharmaceutical Operations Management focuses on key concepts such as: Policy Execution, Risk Management, Supply chain modeling, Advance process control and Six Sigma for the pharmaceutical industry: critical techniques which will offset cost, increase efficiency and turn any manufacture into financial winner.

The Art of Drug Synthesis

Author : Douglas S. Johnson
Publisher : John Wiley & Sons
ISBN 13 : 111867846X
Total Pages : 295 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis The Art of Drug Synthesis by : Douglas S. Johnson

Download or read book The Art of Drug Synthesis written by Douglas S. Johnson and published by John Wiley & Sons. This book was released on 2013-02-26 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Art of Drug Synthesis illustrates how chemistry, biology, pharmacokinetics, and a host of other disciplines come together to produce successful medicines. The authors have compiled a collection of 21 representative categories of drugs, from which they have selected as examples many of the best-selling drugs on the market today. An introduction to each drug is provided, as well as background to the biology, pharmacology, pharmacokinetics, and drug metabolism, followed by a detailed account of the drug synthesis. Edited by prominent scientists working in drug discovery for Pfizer Meets the needs of a growing community of researchers in pharmaceutical R&D Provides a useful guide for practicing pharmaceutical scientists as well as a text for medicinal chemistry students An excellent follow-up to the very successful first book by these editors, Contemporary Drug Synthesis, but with all new therapeutic categories and drugs discussed.

Innovation and Marketing in the Pharmaceutical Industry

Author : Min Ding
Publisher : Springer Science & Business Media
ISBN 13 : 1461478014
Total Pages : 763 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Innovation and Marketing in the Pharmaceutical Industry by : Min Ding

Download or read book Innovation and Marketing in the Pharmaceutical Industry written by Min Ding and published by Springer Science & Business Media. This book was released on 2013-10-31 with total page 763 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical industry is one of today’s most dynamic and complex industries, involving commercialization of cutting-edge scientific research, a huge web of stakeholders (from investors to doctors), multi-stage supply chains, fierce competition in the race to market, and a challenging regulatory environment. The stakes are high, with each new product raising the prospect of spectacular success—or failure. Worldwide revenues are approaching $1 trillion; in the U.S. alone, marketing for pharmaceutical products is, itself, a multi-billion dollar industry. In this volume, the editors showcase contributions from experts around the world to capture the state of the art in research, analysis, and practice, and covering the full spectrum of topics relating to innovation and marketing, including R&D, promotion, pricing, branding, competitive strategy, and portfolio management. Chapters include such features as: · An extensive literature review, including coverage of research from fields other than marketing · an overview of how practitioners have addressed the topic · introduction of relevant analytical tools, such as statistics and ethnographic studies · suggestions for further research by scholars and students The result is a comprehensive, state-of-the-art resource that will be of interest to researchers, policymakers, and practitioners, alike.

Medical Monopoly

Author : Joseph M. Gabriel
Publisher : University of Chicago Press
ISBN 13 : 022610821X
Total Pages : 345 pages
Book Rating : 4.2/5 (261 download)

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Book Synopsis Medical Monopoly by : Joseph M. Gabriel

Download or read book Medical Monopoly written by Joseph M. Gabriel and published by University of Chicago Press. This book was released on 2014-10-24 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: During most of the nineteenth century, physicians and pharmacists alike considered medical patenting and the use of trademarks by drug manufacturers unethical forms of monopoly; physicians who prescribed patented drugs could be, and were, ostracized from the medical community. In the decades following the Civil War, however, complex changes in patent and trademark law intersected with the changing sensibilities of both physicians and pharmacists to make intellectual property rights in drug manufacturing scientifically and ethically legitimate. By World War I, patented and trademarked drugs had become essential to the practice of good medicine, aiding in the rise of the American pharmaceutical industry and forever altering the course of medicine. Drawing on a wealth of previously unused archival material, Medical Monopoly combines legal, medical, and business history to offer a sweeping new interpretation of the origins of the complex and often troubling relationship between the pharmaceutical industry and medical practice today. Joseph M. Gabriel provides the first detailed history of patent and trademark law as it relates to the nineteenth-century pharmaceutical industry as well as a unique interpretation of medical ethics, therapeutic reform, and the efforts to regulate the market in pharmaceuticals before World War I. His book will be of interest not only to historians of medicine and science and intellectual property scholars but also to anyone following contemporary debates about the pharmaceutical industry, the patenting of scientific discoveries, and the role of advertising in the marketplace.

Art of Writing & Publishing in Pharmaceutical Journals

Author : Ajay Semalty
Publisher : Pharmamed Press
ISBN 13 : 9391910408
Total Pages : 191 pages
Book Rating : 4.3/5 (919 download)

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Book Synopsis Art of Writing & Publishing in Pharmaceutical Journals by : Ajay Semalty

Download or read book Art of Writing & Publishing in Pharmaceutical Journals written by Ajay Semalty and published by Pharmamed Press. This book was released on 2023-03-01 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: In academics and research, everyone needs publications. It has always been a vital requirement in an academic & research career. Due to a lack of a comprehensive setup of learning writing skills, career growth is affected. This book provides the foundation for effective paper and thesis writing. The book covers: ¨ Basics of research, review paper, synopsis and thesis writing ¨ Targeting quality journals; Impact factors as journal metrics, detection and avoiding plagiarism. ¨ Planning, executing, reporting, documenting and presenting the research work including empirical studies ¨ Defending thesis, useful resources for writing and research USPs of the book are Easy language, to-the-point coverage of topics, effective presentation, and vital further reading links on every topic. Contents: Section I - Paper Writing 1. Paper Publications in Academic Career 2. Targeting Journals 3. Impact Factor 4. Review Paper Writing 5. Writing a Research Paper 6. Submission & Avoiding Rejections 7. Plagiarism & Ethics in Publications Section II - Thesis/ Dissertation Execution & Writing 8. Introducing Research 9. Planning a Topic 10. Literature Survey 11. Preparing Synopsis 12. Procurements & Execution of Work 13. Results and Discussion 14. Empirical or Field Studies 15. Report Writing 16. Presentation of Work Section III – Appendices Appendix 1 - Funding Agencies Appendix2 - Directory of Major Journals Appendix3 - Directory of Analytical Service Providers Appendix4 - E-Resources on Paper Writing Appendix5 - Important Software for Research and Writing

Predictive Modeling of Pharmaceutical Unit Operations

Author : Preetanshu Pandey
Publisher : Woodhead Publishing
ISBN 13 : 0081001800
Total Pages : 465 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Predictive Modeling of Pharmaceutical Unit Operations by : Preetanshu Pandey

Download or read book Predictive Modeling of Pharmaceutical Unit Operations written by Preetanshu Pandey and published by Woodhead Publishing. This book was released on 2016-09-26 with total page 465 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. - Explains the commonly used modeling and simulation tools - Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing - Practical examples of the application of modeling tools through case studies - Discussion of modeling techniques used for a risk-based approach to regulatory filings - Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points

Pharmaceutical Quality by Design

Author : Walkiria S. Schlindwein
Publisher : John Wiley & Sons
ISBN 13 : 1118895215
Total Pages : 319 pages
Book Rating : 4.1/5 (188 download)

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Book Synopsis Pharmaceutical Quality by Design by : Walkiria S. Schlindwein

Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-01-05 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Forecasting for the Pharmaceutical Industry

Author : Arthur G. Cook
Publisher : CRC Press
ISBN 13 : 1317134109
Total Pages : 323 pages
Book Rating : 4.3/5 (171 download)

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Book Synopsis Forecasting for the Pharmaceutical Industry by : Arthur G. Cook

Download or read book Forecasting for the Pharmaceutical Industry written by Arthur G. Cook and published by CRC Press. This book was released on 2016-03-03 with total page 323 pages. Available in PDF, EPUB and Kindle. Book excerpt: Forecasting for the Pharmaceutical Industry is a definitive guide for forecasters as well as the multitude of decision makers and executives who rely on forecasts in their decision making. In virtually every decision, a pharmaceutical executive considers some type of forecast. This process of predicting the future is crucial to many aspects of the company - from next month's production schedule, to market estimates for drugs in the next decade. The pharmaceutical forecaster needs to strike a delicate balance between over-engineering the forecast - including rafts of data and complex ’black box’ equations that few stakeholders understand and even fewer buy into - and an overly simplistic approach that relies too heavily on anecdotal information and opinion. Arthur G. Cook's highly pragmatic guide explains the basis of a successful balanced forecast for products in development as well as currently marketed products. The author explores the pharmaceutical forecasting process; the varied tools and methods for new product and in-market forecasting; how they can be used to communicate market dynamics to the various stakeholders; and the strengths and weaknesses of different forecast approaches. The text is liberally illustrated with tables, diagrams and examples. The final extended case study provides the reader with an opportunity to test out their knowledge. The second edition has been updated throughout and includes a brand new chapter focusing on specialized topics such as forecasting for orphan drugs and biosimilars.

Research and Development in the Pharmaceutical Industry (A CBO Study)

Author : Congressional Budget Office
Publisher : Lulu.com
ISBN 13 : 1304121445
Total Pages : 65 pages
Book Rating : 4.3/5 (41 download)

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Book Synopsis Research and Development in the Pharmaceutical Industry (A CBO Study) by : Congressional Budget Office

Download or read book Research and Development in the Pharmaceutical Industry (A CBO Study) written by Congressional Budget Office and published by Lulu.com. This book was released on 2013-06-09 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...

Pharmaceutical Manufacturing Handbook

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470259825
Total Pages : 857 pages
Book Rating : 4.4/5 (72 download)

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Book Synopsis Pharmaceutical Manufacturing Handbook by : Shayne Cox Gad

Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-04-04 with total page 857 pages. Available in PDF, EPUB and Kindle. Book excerpt: With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.

Pharmaceutical Metrics

Author : David S. Zuckerman
Publisher : Gower Publishing, Ltd.
ISBN 13 : 056608676X
Total Pages : 160 pages
Book Rating : 4.5/5 (66 download)

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Book Synopsis Pharmaceutical Metrics by : David S. Zuckerman

Download or read book Pharmaceutical Metrics written by David S. Zuckerman and published by Gower Publishing, Ltd.. This book was released on 2006 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'What gets measured gets fixed' and this is as true of the pharmaceutical industry as any other. The problem is that pharmaceutical businesses are complex. Drug research and development involves extended and expensive processes; defining appropriate metrics for these processes is not easy, yet ineffective or misguided metrics can be more damaging than none at all. David Zuckerman's Pharmaceutical Metrics is an extremely practical guide to selecting a system, selling it to top management, choosing and defining the right metrics for your system, communicating and displaying the results. And because metrics are about how to shape and develop your business, he explores how to deploy them organization-wide and make sure that they are driving business improvement. In order to reflect the needs of different types of pharmaceutical company the author uses four sample companies, throughout the book, to illustrate the principles for 'big pharma', 'micro pharma', a virtual development company and a CRO. This highly practical book provides a step-by-step guide to creating a state-of-the-art, strategy-driven metrics system for pharmaceutical R&D, supported by case studies of the techniques applied and tips for optimizing the system.

Bad Pharma

Author : Ben Goldacre
Publisher : Macmillan
ISBN 13 : 0865478066
Total Pages : 479 pages
Book Rating : 4.8/5 (654 download)

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Book Synopsis Bad Pharma by : Ben Goldacre

Download or read book Bad Pharma written by Ben Goldacre and published by Macmillan. This book was released on 2014-04 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.

Pharmaceutical Microbiological Quality Assurance and Control

Author : David Roesti
Publisher : John Wiley & Sons
ISBN 13 : 1119356075
Total Pages : 594 pages
Book Rating : 4.1/5 (193 download)

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Book Synopsis Pharmaceutical Microbiological Quality Assurance and Control by : David Roesti

Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks

The Art of Process Chemistry

Author : Nobuyoshi Yasuda
Publisher : John Wiley & Sons
ISBN 13 : 3527633588
Total Pages : 275 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis The Art of Process Chemistry by : Nobuyoshi Yasuda

Download or read book The Art of Process Chemistry written by Nobuyoshi Yasuda and published by John Wiley & Sons. This book was released on 2010-12-01 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing must-have knowledge for the pharmaceutical industry and process chemists in industry, this ready reference offers solutions for saving time and money and supplying -- in a sustainable way -- valuable products. Application-oriented and well structured, each chapter presents successful strategies for the latest modern drugs, showing how to provide very fast bulk quantities of drug candidates. Throughout, the text illustrates how all the key factors are interwoven and dependent on one another in creating optimized methods for optimal products.