| Comment Record |
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Commentor |
Dr. John Jasper |
Date/Time |
2003-04-01 16:56:57 |
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Organization |
Molecular Isotope Technologies |
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Category |
Company |
| Comments for FDA General |
| Questions |
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1. General Comments
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Molecular Isotope Technologies (www.MolecularIsotopes.com) has developed a means for identifying individual batches of pharmaceuticals (and all other batch-produced products) based on measurements of naturally-existing, non-radioaactive (stable) isotopes that occur in virtually everything. Current research with the FDA CDER, submitted to the journal *Analytical Chemistry,* shows that individual batches of Active Pharmaceutical Ingredients (APIs) can be traced with very high specficity to their original batches. Other research shows that drug products can be similarly traced. It is reasonably inferred that pharmaceutical (and other) raw materials and synthetic intermediates can also be traced. Such product identity should be useful in mitigating counterfeiting, countertrading, vicarious liability, theft, and patent infringement. Please contact us via our website.
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