Animal Pharm's Product Data File
Author | : PJB Publication |
Publisher | : |
Total Pages | : |
Release | : 1990 |
Genre | : |
ISBN | : |
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Author | : PJB Publication |
Publisher | : |
Total Pages | : |
Release | : 1990 |
Genre | : |
ISBN | : |
Author | : Jackie Bird |
Publisher | : |
Total Pages | : 156 |
Release | : 1989 |
Genre | : Animal health industry |
ISBN | : |
Author | : Sarfaraz K. Niazi |
Publisher | : CRC Press |
Total Pages | : 420 |
Release | : 2019-12-05 |
Genre | : Medical |
ISBN | : 135159351X |
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Three, Liquid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this third volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features: Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines
Author | : Karen Smale |
Publisher | : |
Total Pages | : |
Release | : 1993 |
Genre | : Veterinary drugs |
ISBN | : |
Author | : |
Publisher | : |
Total Pages | : 108 |
Release | : 1982 |
Genre | : Information services |
ISBN | : |
Author | : John J. Tobin |
Publisher | : John Wiley & Sons |
Total Pages | : 341 |
Release | : 2023-12-04 |
Genre | : Science |
ISBN | : 3527333266 |
Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/ Manufacturing Practices. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.
Author | : |
Publisher | : |
Total Pages | : 1052 |
Release | : 1985 |
Genre | : Trademarks |
ISBN | : |
Author | : |
Publisher | : |
Total Pages | : 108 |
Release | : 1982 |
Genre | : Agriculture |
ISBN | : |
Author | : |
Publisher | : |
Total Pages | : 52 |
Release | : 1991 |
Genre | : Information services |
ISBN | : |
Author | : |
Publisher | : |
Total Pages | : |
Release | : 1990 |
Genre | : Databases |
ISBN | : |
Directory of "2805 database in 2509 entries." Science, technology, medicine, business, law, humanities, and social sciences are covered. Entries give such detailed information as data elements, subject matter, and user aids. Name, subject, producer and processor indexes.