Only when the preclinical studies demonstrate adequate safety and the new agent shows promise as a useful drug will the drug's sponsor file an ________(1)_______ with the FDA for initial testing in humans. If the drug demonstrates adequate _______(2)________ in these initial human studies, termed Phase 1, progressive human trials through Phases 2 and 3 are undertaken to assess ______(3)_______ and ______(4)______. As the clinical trials progress, laboratory work continues toward defining the agent's basic and clinical pharmacology and toxicology, product design and development, manufacturing scale-up and process controls, analytical methods development, proposed labeling and package design, and initial plans for marketing.
a. abbreviated new drug application
b. efficacy
c. safety
d. pharmacokinetics