Understanding Pharma
Author: John J. Campbell
Publisher: Pharmaceutical Press
Published: 2008-01-01
Total Pages: 311
ISBN-13: 9780976309635
DOWNLOAD EBOOKRead and Download eBook Full
Author: John J. Campbell
Publisher: Pharmaceutical Press
Published: 2008-01-01
Total Pages: 311
ISBN-13: 9780976309635
DOWNLOAD EBOOKAuthor: Shayne Cox Gad
Publisher: John Wiley & Sons
Published: 2008-03-11
Total Pages: 1386
ISBN-13: 0470259809
DOWNLOAD EBOOKThis 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
Published: 2006
Total Pages: 1526
ISBN-13: 924156301X
DOWNLOAD EBOOKThe 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:
Published: 2013-11
Total Pages:
ISBN-13: 9780938367819
DOWNLOAD EBOOKAuthor: Lesley Richmond
Publisher: Routledge
Published: 2017-10-05
Total Pages: 589
ISBN-13: 1351884298
DOWNLOAD EBOOKThe 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
Published: 2003
Total Pages: 500
ISBN-13: 9780852954409
DOWNLOAD EBOOKThis 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: Javed Ali
Publisher: Academic Press
Published: 2021-11-14
Total Pages: 287
ISBN-13: 0128222239
DOWNLOAD EBOOKRegulatory 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: Patrick M. Malone
Publisher: McGraw Hill Professional
Published: 2010-05-12
Total Pages: 907
ISBN-13: 0071492038
DOWNLOAD EBOOKExtensive 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: Shayne Cox Gad
Publisher: John Wiley & Sons
Published: 2008-04-04
Total Pages: 857
ISBN-13: 0470259825
DOWNLOAD EBOOKWith 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: World Health Organization
Publisher: World Health Organization
Published: 2024-04-26
Total Pages: 382
ISBN-13: 9240091033
DOWNLOAD EBOOKThe Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines and provision of global regulatory tools. The Expert Committee develops standards through worldwide consultation and an international consensus-building process. The following new guidance texts were adopted and recommended for use: WHO good manufacturing practices for excipients used in pharmaceutical products (revision); IAEA/WHO good manufacturing practices for in-house cold kits for radiopharmaceutical preparations (new); WHO good practices for pharmaceutical quality control laboratories (revision); WHO/UNFPA female condom generic specification (new); WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release (updated), solid oral dosage forms; WHO guideline on Biopharmaceutics Classification System-based biowaivers (revision); and Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (republished). All of the above are included in this report and recommended for implementation.