Aspects of Packaging from NDA <- IND |
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| Authors: | J. T. Carstensen Myron Slotsky Dorothy Dolfini |
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| Affiliation: | a University of Wisconsin, Madison, WIb Marion Labs, Kansas City, MO |
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| Abstract: | The strategic decisions regarding package stability in an NDA should be thought out even before the IND stage (hence the inversion of the order of the words NDA and IND in the title). The philosophy of clinical blister packaging is discussed as are the tests necessary to ensure perfection of seal. The principles of molecular and pinhole moisture permeation are discussed. Suggested fractional factorial schemes for package testing are presented |
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