It is an essential reference source for pharmaceutical developers involved in formulation, development, manufacture, process controls, IPQC, Scale-up, Validation and Quality Control of pharmaceutical generic target specific dosage form selected. Designed for both generic and new innovative dosage forms in the development pipeline. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.
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The data in the handbooks is equivalent to a full data base necessary to manufacture a pivotal batch for submission to the OGD. Designed for both generic and innovative drug products in the development pipeline.
Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition
Major topics discussed include: Drugs and the Pharmaceutical Sciences. An authoritative and essential tool for drug developers and regulatory agency review personnel. Intended to supply all necessary data from first look handbbook approved generic application.
He spent several years in the pharmaceutical industry in Canada and has written or contributed to several book chapters and more than research publications and conference presentations. Written for Industry in two easy-to-use complementary handbooks, with a unique modular format and as-you-submit data layout. Sathe, John Duan, and Lawrence X. Available monthly on CD containing a selection of ten generic drug master formula and manufacture process. Learn More about VitalSource Bookshelf.
Includes a comprehensive DMF section and regulatory aspects.
Locum Int - Handbooks- Handbook catalog - Drug Development Series
An essential reference source for pharmaceutical generic and innovative scientists involved in formulation, development, stability, scale-up, new generic dosage forms or pharmaceutical Quality Control. Already read this title? Ideal in-house training material for pharmaceutical graduates.
It presents various aspects of generic drug product development with formulation development through to post-approval changes.
CPD consists of any educational activity which helps to maintain and develop knowledge, problem-solving, and technical skills with the aim to provide better health care through higher standards.
Hzndbook are 10 CDs in the series.
Each topic is a development stage and is supplemented with unique flowcharts, checklists, tables, graphs and product specific key Development SOPs. Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing decelopment development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval.
The student resources previously accessed via GarlandScience. Establishes a clear and comprehensive set of regulatory specifications for drug product actives for QC, RA and agency review personnel.
This edition includes a new chapter on the U. In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug develooment in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.
Available on CD, each disk contains a selection of ten generic drug master formula and manufacture process. D escribes over key development steps from pre-fomulation to commercial dfvelopment.
Kanfer received his B. Davit and Dale P. Add to Wish List.
Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition - CRC Press Book
This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and handboo, professionals working in the area of generic drug development. In Vivo; Barbara M. It could be through conference attendance, group discussion or directed reading to name just a few examples. The book is a thorough guide to the development of solid oral generic dosage formulations.
A substantial authoritative work per dosage form as a 24 volume series with side-by-side devepopment of in-use US and EU ANDA commercial formula and processing instructions.
Written by practicing formulation pharmacists. The Generic Development Series includes: