IAGIM - Drug Development Association

Available: Print

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.


Vol, Edition # and Pub. Year.

H/B Vol 5/Ed 18 - 2018
H/B Vol 5/Ed 19 - 2019
H/B Vol 5/Ed 20 - 2020
H/B Vol 5/Ed 21 - 2021
H/B Vol 5/Ed 22 - 2022
H/B Vol 5/Ed 23 - 2023
H/B Vol 5/Ed 24 - 2024

New Updated Edition Annually

Handbook Generic Development
Soft Gelatin Capsules

A Two Part Development to Final Production Handbook

Locum Press Edition International.

Volume 5-SE or 5-AE (Standard or Advanced Edition - 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/CMC/Dossier Module development project. Available in standard and advanced edition in print and electronic CD or Online Dropbox. Advanced edition includes gelcoated caplets [GCC] and formulations of gelcoated coatings of advanced caplet coatings and gelcoated CR / MR caplets and softgels.

Each product specific handbook focuses exclusively on single dosage form and in essence informs and guides the SGC innovator or product developer (a) what exactly must be done (b) once it is completed how to write and format the raw data (c) what the various agencies expects to see in each section or module and (d) what the developer must not leave out. Including all common tips, traps and pitfalls for the specific dosage form. Copious and detailed checklists ensure that product development has no developmental gaps, oversights or regulatory errors.

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 SG Capsule and GCCaps technology know-how on all aspects of development, formulation, formulation tables, current marketed formulas. Equipment, scale-up, process optimization & qualification; troble shooting, pivotal and large scale validation batches; analytical, cleaning and process validation; essential documentation and OGD / EU regulatory know-how that is essential for a successful review for a FDA /EU product approval, saving lengthy queue-time and money. Product development budgets can be reduded by up to 50% in the product development cycle, thus avoiding all the common developmental dead-ends for this specific dosage form.

A reference for critical documentation and OGD / EU regulatory know-how that is essential for a successful first time FDA / EU review and approval, saving months of queue-time, developmental, regulatory and production dead-ends and lost market place sales of not being first in the approval queue..

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 and gelatin coated caplets, GCCaps (in popular US / EU OTC and prescription commercial formulations namely Ibuprofen, Na Naproxacin 220mg, KI etc. for advanced developers to understand the nuts-and-bolts of generic SGC and GCC development with corresponding high-tech, detailed advanced US and EU developmental / registration and commercial production technology and inhouse know-how.

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 1890-1990 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 read onlt and printable editions (10, 25 & 50 multi-users require additinal optional license)
. Split volume attract a 25% handling and broken volume charge to split the two part volume.

0793-8675 / 0793-8683

All air shipping is 100% insured for loss or replacement. Shipping rates are: | Standard | Priority | Expedited.|

Price Go To: Locum International Catalog

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