Promotes the development and sharing of practical drug development knowledge and technology by agency and industry experts alike.

The world's most definitive & authoritative current generic drug development series available.

"This softgel reference is truly unique and excellent
- Ranbaxy"

"simply the best reference we've got" - RP Scherer.

Handbook Generic Development
Soft Gelatin Capsules
A Two Part Development Handbook

Locum Press Edition International.

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

The Handbook of Pharmaceutical Generic Development is an essential workbook and definitive reference covering the full and detailed development, CMC, RA and legal sections for a single dose Soft Gelatin Capsule ANDA development project.

Each product specific handbook focuses exclusively on single dosage form and in essence informs and guides the product developer (a) what exactly must be done (b) once it is completed how to write and format the raw data (c) what the agency expects to see in each section and (d) what the developer must not leave out.

Each and every agency guideline and development requirement is thoroughly dealt with in a step-by-step manner in order to avoid the pitfalls occurring during product development. TOC for US and EU eCTD and CTD.

Provides essential capsule technology know-how on all aspects of development, formulation, formulation tables. Equipment, 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.

A reference for critical documentation and OGD regulatory know-how that is essential for a successful first time FDA review and approval, saving months of queue-time and market place sales.

Every regulatory guideline is covered in clear explanatory detail providing a development protocol for a totally omission-free file submission.

Essential development know-how on Oral Soft Gelatin capsules for advanced developers to understand the nuts-and-bolts on generic SGC development with corresponding high-tech, detailed developmental ANDA know-how.

Complete Volume in two parts 1690-1850 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: 0793-8675 / 0793-8683

All air shipping is 100% insured for loss or replacement. Shipping rates are:
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Price: Locum International Catalog

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