Final answer:
The statement is false; drug manufacturers initiate clinical trials to establish a drug's safety for human use. These trials are conducted after preliminary laboratory and animal studies and before the drug can be marketed. Ongoing post-market surveillance is critical for assessing long-term safety and specific population effects.
Step-by-step explanation:
It is false that drug manufacturers complete their studies before they initiate clinical trials to be sure the drug is safe to give to patients. Initial studies, which include laboratory and animal research, are conducted to establish some degree of safety and efficacy. However, the true safety profile of the drug for human subjects is established during the clinical trials themselves, which are composed of multiple phases, each designed to gather more information about the drug's safety, dosage, effectiveness, and side effects.
The clinical trials process begins with a first administration to humans in phase I after the submission of an Investigational New Drug (IND) application to the FDA. Phase I trials aim to assess the safety and tolerance of the drug in humans. If a compound is found to have acceptable safety profiles and pharmacokinetic properties, it moves on to further phases. Only after a New Drug Application (NDA) can a drug be considered for FDA approval to be marketed. Post-approval, there is an ongoing process of monitoring the drug's effects in larger patient populations.
Adverse outcomes or side effects that may not have been fully understood during clinical trials can be more fully explored once a drug reaches the market. This continued evaluation is significant for understanding long-term safety and the effect of the drug on specific subgroups of patients.