For a drug like Propafenone, can we do a replicate study as well as 2 way cross over study?
RP: As you know the power of replicate design is to get the estimate of the intra-subject variability of the test and reference. Since now we use only average BE analysis and criteria, and individual or population BE analysis and criteria are not acceptable/allowed by the regulatory agencies, the primary advantage of replicate design is reducing the number of subjects for a BE study that requires a large “N”. In short, the answer to your question is yes, you can do a replicate design and analyze the data by the average BE analysis and criteria. 43. Which design is preferred by USFDA as the drug has high variability ,non linear Kinetics and has food effect also. The drug is quite risky to give under fed Conditions as concentration increases 4 times and we risk a healthy volunteer who can develop a 1st degree heart attack? Please clarify. RP: The answer is simple; if it is not safe to give this drug to normal healthy volunteers then it should not be given to normal healthy volunteers. It
