The document discusses the roles and obligations of auditors in medical trials In line with ICH GCP recommendations. It states that auditors are accountable for independently analyzing demo routines and documents to validate compliance with protocols, SOPs, GCP, and polices.A description in the drug substance, including its Actual physical, chemica
It does not require preclinical and clinical trials but must show bioequivalence via bioavailability and bioequivalence research. The ANDA contents and overview approach are outlined according to the Popular Technical Doc format in 5 high-quality, nonclinical, and clinical modules.) the kinds of clinical trials for being conducted in the very first
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