Available: Print or CD






LOCUM INT. PRESS
Vol, Edition # and Pub. Year.

H/B Vol 17/Ed 19 - 2019
H/B Vol 17/Ed 20 - 2020
H/B Vol 17/Ed 21 - 2021
H/B Vol 17/Ed 22 - 2022
H/B Vol 17/Ed 23 - 2023
H/B Vol 17/Ed 24 - 2024
H/B Vol 17/Ed 25 - 2025
H/B Vol 17/Ed 26 - 2026

New Edition Annually

Handbook Generic Development
Master Formula & Manufacturing Processes
(10 Parts)

Locum International Press..

Volume 17 - (Parts 1 - 10) of the
Special Drug Development Series on CD ROM

A Glimpse into the Future
IAGIM Drug Development follows the following classical generic development approach. Download or read online in PDF the development guidelines and flowcharts involved in the overall drug development process from pre-formulation to commercial validation of three production sized batch lots.

Title 17 allows researchers to view key formula and process data and then upgrade to the full database of the Title 21 CMC Ready-To-Go Production Dossiers containing.

1. Literature Research (Extensive search, + FDA SBA)
2. Bulk Active Sourcing
3. Innovative and /or RLD drug product reverse engineering
4. Pre-formulation and development process
5. Final formulation and process
6. Bulk Active Approval with analytical assay validation
7. Product and Process Optimization
8. Product and Process Qualification
9. Product and Process Master Documentation
10 Comparative Dissolution Profiling & stability testing (Extensive)
11. Scale-up & Pivotal lot (+ CDP / IVIVC & stability testing)
12. Commercial Process Validation (CDP & stability testing)

Total CD series is available as a complete ten part volume of 10 CDs with illustrated diagrams, graphs, tables in b/w/color. ISBN: 0793-6643

Title 17 selections are upgraded, updated and changed from time-to-time to provide a suitable variation in product choices. Title 17 are updated annually in parallel with Title 21 Ready-To-Go CMC Series
Some restrictions apply.

 

 

 


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