Question

Match the following phases of the FDA process of assessing safety and effectiveness of drugs and the phases' objectives. Establish efficacy for one indication among a homogeneous group of patients compared to conventional treatment. Choone... Choose... Establish that there is enough evidence of efficacy to warrant Preclinical testing randomized controlled trials. Phase 4 Phase 2 Detect rare but serious side effects as well as increased frequency of known side effects. Phase 3 Assess carcinogenic, teratogenicity, and fertility effects in Phase 1 CTIUUS animals. Assess pharmacology, including metabolism and excretion, in an effort to establish dosage, timing, and route of administration. Choose...

Answer 1

Assess carcinogenic,teratogenecity and fertility effects in animals-pre clinical testing assist know about the effects of medicini in animals

Phase 1-assess pharmacology including metabolism and excretion in an effort to establush dosage timing and route of administration.

Phase 2-detect rare but serious side effects as well as increased frequency of known side effects.

Phase 3-establiah efficancy one indication among homogenous group of patient compared to conventionel treatment.

Phase 4-establish that there is enough evidence of efficacy to warrant randomised controlled trial.

These steps enables to apply medicines with out causing any harm to individuals as it isgested in various phases to know effectiveness and complication of drug.