Promotes the development and sharing of practical drug
development knowledge and technology by agency and industry experts alike.Note: Strongly recommended for innovative drug development, highlighting all common tips and traps of experienced drug developers
of Generic Development
Oral IR Capsules
A Two Part Development To Final Production Handbook
Locum International Press
Volume 2 & 2E (Complete Handbook volume in Two Parts)
of the 24 Volume Drug Development Series
This definitive Handbook of Pharmaceutical Generic Development is an essential workbook and reference covering the full development, formulation, CMC, RA and legal sections for a Single Dose IR Capsule US and EU development project. Structured to walk readers through the different aspects of product development in a logical fashion
Designed to specifically eliminate the potential risks and common process omissions in drug development and claimed as the world's most authoritative and definitive work available on oral dosage form drug development from a generic industry viewpoint.
Comprehensive treatment with contributions from international recognized leaders in the field
Practical & Hands-on
This Handbook of Pharmaceutical Generic Development is a practical hand-on workbook covering the practical hands-on development for single dose oral capsules. It promotes the development and sharing of practical drug development knowledge and solid dose technology from government agency and industry experts alike.
Complete development know-how and common error erdication with detailed commercial and state-of-the-art formula provides essential capsule technology know-how on all aspects of; Development, Formulation, Dissolution, stability, Scale-up, Process Optimization & Qualification; Pivotal and large scale Validation batches; Analytical, cleaning and process validation; essential documentation and OGD regulatory know-how that is essential for a successful review for a FDA approval, saving queue-time and money.
Essential development know-how on Oral Capsules for professional developers to understand the nuts-and-bolts on Generic ANDA drug development to produce flawless files
Development pharmacists, R&D chemists and scientists in pharmaceutical companies and university departments, in the areas of innovative, new drugs and generic drug development, QA / QC. validation and regulatory personnel.
Complete Volume in two parts 1790-1990 pp. Part 1 and 2 fully illustrated with diagrams, flow charts, graphs, side-by-side comparisons, tables in b/w & color. Available in print (spiral soft cover) or via digital CD (multi-users require additinal optional license) ISBN: 0793-8731 / 0793-8722
Locum International Press are one of the world leading scientific R&D publishers offering an exceptional range of peer reviewed journals, handbooks, book databases and an unique publishing services to the pharmaceutical science community. We also offer a large and comprehensive range of product specific generic handbooks to the pharmaceutical generic drug and innovative drug R&D community
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