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IND-Enabling Program Information Examples (small and large molecule)

Small or Large Molecule IND Program? *:

Small molecule IND program (basic parameters): oral gavage route of administration, standard small and large species selection, 28 days duration, once-daily administration, recovery/reversal phase (28 days), standard toxicokinetic sampling schedule with analytical and bioanalytical method transfers
Large molecule IND program (basic parameters): bolus injection route of administration, standard small and large species selection, 4 weeks duration, once-weekly administration, recovery/reversal phase (4 to 6 weeks for small and large species), standard toxicokinetic sampling schedule with analytical, immunogenicity and bioanalytical method transfers

IND-Enabling Supportive Information (for alternative program design)

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