Studies in humans, tentatively planned for next year, would be necessary to establish the drug's safety and efficacy in people.

Establishing a drug's safety and efficacy is not a pretty business.

Unlike any other new drug application in recent memory, the DDI application does not include data from the standard tests to establish safety and efficacy.

These descriptive studies do not establish efficacy because of the absence of an appropriate control group.

A 1997 pharmacokinetic trial to establish efficacy of peptide administration compared intravenous, oral and subcutaneous routes.

The law demands no ongoing long-term clinical trials to establish either the safety or efficacy of these supplements.

To establish efficacy, an antidepressant must show that it can produce a therapeutic effect for the condition for which it is taken.

Under current law, supplement manufacturers may sell products without first having to establish their safety or efficacy.

Second, at least three copies of test reports and research data necessary to establish purity, safety, potency, and efficacy of the product must be attached.

A vaccine trial is a clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed.