Understanding Pharma PDF Download

Author: John J. Campbell
Publisher: Pharmaceutical Press
ISBN: 9780976309635
Category : Pharmaceutical industry
Languages : en
Pages : 311

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Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259809
Category : Science
Languages : en
Pages : 1386

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Book Description
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: 924156301X
Category : Medical
Languages : en
Pages : 1526

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Book Description
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: Marietta Miemietz
Publisher:
ISBN: 9780938367819
Category :
Languages : en
Pages :

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Author: Javed Ali
Publisher: Academic Press
ISBN: 0128222239
Category : Medical
Languages : en
Pages : 287

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Book Description
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: 1351884298
Category : History
Languages : en
Pages : 589

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Book Description
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: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259825
Category : Science
Languages : en
Pages : 857

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Book Description
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: Bill Bennett
Publisher: IChemE
ISBN: 9780852954409
Category : Medical
Languages : en
Pages : 500

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Book Description
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: Patrick M. Malone
Publisher: McGraw Hill Professional
ISBN: 0071492038
Category : Medical
Languages : en
Pages : 907

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Book Description
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: 9240011870
Category : Business & Economics
Languages : en
Pages : 70

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Book Description
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.