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Author : John J. Campbell
Publisher : Pharmaceutical Press
ISBN 13 : 9780976309635
Total Pages : 311 pages
Book Rating : 4.3/5 (96 download)
Download or read book Understanding Pharma written by John J. Campbell and published by Pharmaceutical Press. This book was released on 2008-01-01 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470259809
Total Pages : 1386 pages
Book Rating : 4.4/5 (72 download)
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.
Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 924156301X
Total Pages : 1526 pages
Book Rating : 4.2/5 (415 download)
Download or read book The International Pharmacopoeia written by World Health Organization and published by World Health Organization. This book was released on 2006 with total page 1526 pages. Available in PDF, EPUB and Kindle. Book excerpt: The International Pharmacopoeia contains a collection of recommended methods for analysis and quality specifications for pharmaceutical substances, excipients and products. This new edition consolidates the texts of the five separate volumes of the third edition and includes new monographs for antiretroviral substances (didanosine, indinavir sulfate, nelfinavir mesilate, nevirapine, ritonavir, saquinovir, and saquinovir mesilate) adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2004. It includes some additions and amendments to the general notices of the Pharmacopoeia, as well as some changes to its layout and format. Volume one contains monographs for pharmaceutical substances A to O and the General Notices; and volume two contains monographs for pharmaceutical substances P to Z, together with those for dosage forms and radiopharmaceutical preparations, the methods of analysis and reagents.
Author : Javed Ali
Publisher : Academic Press
ISBN 13 : 0128222239
Total Pages : 287 pages
Book Rating : 4.1/5 (282 download)
Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Author : Lesley Richmond
Publisher : Routledge
ISBN 13 : 1351884298
Total Pages : 589 pages
Book Rating : 4.3/5 (518 download)
Download or read book The Pharmaceutical Industry written by Lesley Richmond and published by Routledge. This book was released on 2017-10-05 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical industry has changed beyond all recognition in the past 100 years. The modern industry is constantly in the news as new breakthroughs in medical treatment are announced, often provoking ethical and social debates about the implications of new technologies. This volume facilitates the study of the industry by providing information on the present location of pharmaceutical archives. The core of the book consists of a business-by-business guide to the industry's records. Each entry includes a brief history of the company, a summary of its surviving archives and a bibliography of related publications. Similar entries exist for trade associations and schools of pharmacy associated with the industry and there are two appendices listing small collections of records held and relevant public records. The historical compendium is supplemented by three introductory essays, written by leading academics in the field, outlining the history of the industry and describing the nature and uses of the archival records which it has created. These essays are supplemented by a select chronology of pharmaceutical legislation and a select bibliography of histories relating to the pharmaceutical industry in general. A users guide helps readers understand how the business entries were constructed and is supplemented by a glossary of terms used in this book As such, this book will no doubt prove an invaluable resource to researchers undertaking comparative studies of the pharmaceutical industry, the history of medicine and the retailing of medical drugs.
Author : Bill Bennett
Publisher : IChemE
ISBN 13 : 9780852954409
Total Pages : 500 pages
Book Rating : 4.9/5 (544 download)
Download or read book Pharmaceutical Production written by Bill Bennett and published by IChemE. This book was released on 2003 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title is a general introduction aimed at all those involved in the engineering stages required for the manufacturr of the active ingredient and its dosage forms.
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470259825
Total Pages : 857 pages
Book Rating : 4.4/5 (72 download)
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.
Author : Patrick M. Malone
Publisher : McGraw Hill Professional
ISBN 13 : 0071492038
Total Pages : 907 pages
Book Rating : 4.0/5 (714 download)
Download or read book Drug Information written by Patrick M. Malone and published by McGraw Hill Professional. This book was released on 2010-05-12 with total page 907 pages. Available in PDF, EPUB and Kindle. Book excerpt: Extensive coverage of the Internet as a source of and distribution means for drug information, and detailed sections on evaluating medical literature from clinical trials Audience includes Pharmacists, Pharmacy students and Pharmacy schools Updated to include using PDAs for medication information Covers the ethical and legal aspects of drug information management Nothing else like it on the market
Author :
Publisher : World Health Organization
ISBN 13 : 9240011870
Total Pages : 70 pages
Book Rating : 4.2/5 (4 download)
Download or read book WHO guideline on country pharmaceutical pricing policies written by and published by World Health Organization. This book was released on 2020-09-29 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.
Author : Alex Dmitrienko, Ph.D.
Publisher : SAS Institute
ISBN 13 : 1629590304
Total Pages : 464 pages
Book Rating : 4.6/5 (295 download)
Download or read book Pharmaceutical Statistics Using SAS written by Alex Dmitrienko, Ph.D. and published by SAS Institute. This book was released on 2007-02-07 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.
Author :
Publisher :
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.3/5 (91 download)
Download or read book Guideline on General Principles of Process Validation written by and published by . This book was released on 1987 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : David Roesti
Publisher : John Wiley & Sons
ISBN 13 : 1119356075
Total Pages : 594 pages
Book Rating : 4.1/5 (193 download)
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
Author : Lawrence Tim Friedhoff
Publisher : Booksurge Publishing
ISBN 13 : 9781419699610
Total Pages : 0 pages
Book Rating : 4.6/5 (996 download)
Download or read book New Drugs written by Lawrence Tim Friedhoff and published by Booksurge Publishing. This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug development, the processes by which a chemical compound becomes a "drug" and is approved for sale by the FDA and European and Asian regulators, is not for the faint-of-heart or the shortsighted. Designing and monitoring studies, obtaining and analyzing scientific data, and reconciling clinical results against the ethical constraints and regulatory guidelines of government agencies, requires a complex interaction of in-house specialists and academic and commercial consultants worldwide. Scientific, technical, and tactical considerations play out in an environment where a balance must be struck between the often-competing interests of the corporation, its investors, government regulators, and the safety and well being of intended patients. All the while, dwindling patent protections impose an ever-contracting timeframe for success. Written to be accessible to a wide audience, NEW DRUGS provides a thorough, succinct, and practical understanding of these drug-development processes. If you're involved in the pharmaceutical industry, NEW DRUGS will provide scientific and management tools to increase the likelihood of regulatory approval at each phase of your compound's development. If you're a patient or consumer, NEW DRUGS will enable you to intelligently discuss medications with your health-care provider and empower you to make informed decisions at the pharmacy. If your portfolio, rather than your health, makes you an interested observer of the fortunes of this critical sector of the US economy, NEW DRUGS will help you to decode press releases and annual reports, so that you can recognize and invest in well-run companies with promising products.
Author : Safaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1420081314
Total Pages : 458 pages
Book Rating : 4.4/5 (2 download)
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
Author : Andrew Teasdale
Publisher : John Wiley & Sons
ISBN 13 : 1118971132
Total Pages : 624 pages
Book Rating : 4.1/5 (189 download)
Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-09-29 with total page 624 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Author : Ben Goldacre
Publisher : Macmillan
ISBN 13 : 0865478066
Total Pages : 479 pages
Book Rating : 4.8/5 (654 download)
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.
Author : Judith Grice
Publisher :
ISBN 13 : 9780853697176
Total Pages : 0 pages
Book Rating : 4.6/5 (971 download)
Download or read book Global Pharmaceutical Marketing written by Judith Grice and published by . This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Worldwide, there are varying Codes of Practice/Conduct for the pharmaceutical industry that ensure the industry self-regulates to promote the appropriate use of medicines by operating in a professional, ethical and transparent manner and ensuring high standards. The aim of this book is to aid the understanding of the many pharmaceutical Codes of Practice/Conduct throughout the world. It contains an overview of the guidelines for the promotion of pharmaceutical products in all geographical areas. Each section includes a "general overview" providing a discussion on that particular Code of Practice and differences/similarities with other countries
