Available: Print or CD
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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| Ready-To-Go Link
| Handbook Series | Journal
Index | Specialized Journals
| Title
17 Calandar |
