Handbook Generic Development
Soft Gelatin Capsules
A Two Part Development Handbook

Locum International Press

Volume 05 - (Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series

SGC Handbook provides essential SG capsule technology know-how on all aspects of development, pre-formulation, final formulation, scale-up, process optimization & process qualification; pivotal and large scale validation batches; analytical, cleaning and process validation; essential documentation, protocols, checklists, flowcharts and key SOPS designed in compliance with international regulatory know-how that is essential for a successful review for a EU / FDA / ICH / Asian product development and approval, saving valuable queue-time and costly development dollars.

The Handbook of Pharmaceutical Generic Development is avaiolable as a STANDARD or ADVANVED EDITION. Updated annually it is an essential A to Z SGC workbook covering modern technological advances, do's and don'ts, lastest SGC development technology, complete analytical methology, production CMC / CTD modules and sections for a single dose Soft Gelatin Capsule CTD / ANDA development project up to and including full size large-scale commercial production batchlots.

SEAMLESS INTEGRATION
An Essential Reference for Development Pharmacists, R&D Chemists, QA/QC and Regulatory personnel. Each and every document, protocol and procedure in Part I + II is expertly referenced to the appropriate module number in the CTD / e-CTD system thus providing a fully seamless and effortless integration into either US, EU and Asian application files and dossier. All IAGIM technology is purposely and uniquely dove-tailed in regulatory drug product applications -worldwide appliations made simple and precise.

Critical and key development know-how on Oral Soft Gelatin Capsule for advanced developers to understanding international compliance management and the nuts-and-bolts on Generic SGC Development and manufacture maximizing your detailed and comprehensive high-tech FDA-EU-ICH working knowledge of Soft Gelatin Capsule know-how and particle engineering technologies for better drug performance (including nanodosage forms)

Complete Volume in two parts 1890-2000 pp. Part 1 and 2 fully illustrated and annotated with diagrams, flow charts, formula, graphs, spectra, side-by-side comparisons, tables in b/w & color. Available in print (spiral soft cover opens flat) or via digital CD (multi-users require additinal optional license). Split volume attract a 25% handling and broken volume charge to split the two part volume.ISBN: 0793-8675 / 0793-8683

About Us
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 pharmaceitical generic drug and innovative drug R&D community.

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