Which of the following statements about phase IV clinical trials is true?
Phase Name Purpose I Human Pharmacology and safety To know the Maximum tolerable dose > Dose > Pharmacokinetics > Safety II Therapeutic Exploratory To establish therapeutic efficacy, dose ranging and ceiling effect III Therapeutic Confirmatory To Confirm therapeutic efficacy and To establish the value of drug in relation to existing therapy IV Post-Marketing Surveillance To know rare and long term adverse effects. Special populations like pregnancy and children can be tested 0 (ZERO) Micro-dosing studies To know pharmacokinetics Could avoid costly phase I studies for drugs with unsuitable pharmacokinetics
It is done for pediatric drugs
It is done for rare drugs
It is post-marketing surveillance of drugs
It is also called human pharmacology and safety studies
CLINICAL TRIALS, DRUG LABEL