In Phase II. a drug is evaluated for its efficacy and safety in patients with specific diseases. As a rule, these are placebo - controlled trials. Sometimes, Phase II of a clinical trial is divided into phases IIa and IIb. The purposes of Phase II trial are to evaluate short-term safety of a drug (IIa ) and to confirm clinical efficacy of a drug and determine the therapeutic dose range (IIb ).
No comments:
Post a Comment