Biostatistician Interview Questions and Answers

Regulatory guidelines are rules and regulations set by regulatory bodies to ensure safety and efficacy of drugs and medical devices.

• Regulatory guidelines vary by country and region

• In the US, the FDA sets guidelines for drug and medical device approval

• In Europe, the EMA sets guidelines for drug and medical device approval

• Regulatory guidelines cover aspects such as clinical trials, manufacturing, labeling, and post-market surveillance

• Adherence to regulatory guidelines is mandat...read more

BA BE studies use parallel, crossover, and replicate designs.

• Parallel design: subjects receive either test or reference drug in separate groups

• Crossover design: subjects receive both test and reference drug in random order

• Replicate design: multiple doses of test and reference drug are given to subjects

• Examples: Two-period, two-sequence crossover design; Parallel design with two treatment groups