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READY-TO-GO CMC & HANDBOOK SERIES


The Differences - From Production CMC to Authoritative References

Ready-To-Go CMC Title 21 Series
 
Ready-To-Go Title 19 Handbooks
Title 21 - ' Just Production '
 
Title 19 - ' The Full Reference Work'


Title 21 - Ready-To-Go CMC
Series

Are essentially "Production Ready" complete documentation Chemistry Manufacturing and Control Dossiers containing the active material specifications, full master formulation and manufacturing process and specification up to commercial validation. (ToC)

Detailed manufacturing production process, control and specification database required for large scale validated commercial processes (includes actual protocol) from 150 000 to one million plus dosage unit batch lots.

The analytical data package with stability indicating HPLC assay and dissolution methods together with stability tabulated profile analysis are included (where not current USP methods).

The product database is based on the CMC information found in an existing commercial US file or and EU Dossier and saves many months of product development - eliminating costly drug development, tedious analytical development and validation, pre-formulation, formulation, optimization, scale-up, written protocols, stability and process qualification as well as many aspects of analytical and process validation.

Abbreviated Title 21 e-Files - are cost effective
Abbreviated Title 21 e-Files are available at about a third of the full version cost and are designed for the review abbreviated key formulation and summary outline production data for those who require an early review of the data before expanding their drug development pipeline rapidly and need to save 9-12 months in the development process.


 


Title 19 Ready-To-Go
Handbook Series
.
This Handbook Series (collectively known as the '120+ Series') is targeted at an advanced postgraduate R&D level and covers each and every aspect of drug development to commercial validation for the specific target title drug.


These Handbooks are suitable for R&D and Generic Development units as complete authoritative reference works for the particular target drug in question (such as Tamoxifen, Famotidine or Nabumatone etc.)

The Title 19 Handbooks are more significantly more detailed and complete reference works and include extensive drug development work of the specific generic product - including content uniformity qualification and/or hardness range and dissolution profiles for tablets as appropriate.

The text includes detailed drug development procedures and a FDA-level Development Report not found in the Title 21 Series.

The Reference work contains additional up-to-date commercial production CMC databases, stability and comparative dissolution profiles and CDP graphs against the innovator that is imminently suitable for immediate manufacturing qualification, as found and is priced at 25% - 40 % above the Title 21 Ready-To-Go CMC Series.

TITLE 21 - CMC   TITLE 19 - HANDBOOKS

TITLE COMPARISON
Above description shows the differences between the two references series - designed for different personnel, reference
and research uses. Title 19 is designed for Drug Development to Commercial Validated Batches (from A-Z) - while Title 21 contains standard plant know-how database technology similar to a CMC technology transfer and is a more cost effective purchase. Title 21 are designed for in-house continual development and are available to IAGIM members at 2-3 products per month as the latest data becomes available to IAGIM research laboratories. All IAGIM research is solely for specific membership development use only under copyright and not for resale to nonmember third parties or countries.

 

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