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B. Amsden

CHEE 440

IND Contents

manufacturer/sponsor name

proprietary name and chemical name of drug

dosage form (route of administration, ingredients, manufacture procedure, packaging, purity, labelling)

data from preclinical animal trials

relationship between preclinical and clinical trials

protocol of clinical trials

names and credentials of all persons involved in all trials

locations of laboratories used

info an any other clinical trials done in other countries

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