Bioequivalence and Bioavailability Forum

❝ May I know the types of BA/BE studies.

• absolute (i.v.)
  
• absolute (e.v.) vs. (i.v.) - sometimes also called relative BA
  
• relative (see above); also (e.v.) vs. (e.v.)

• Special type of comparative BA, where reference = innovator's product.

• Pilot study (exploratory: checking bioanalytics, sampling schedule, T/R-ratio, CV)
  
• Pivotal study (confirmatory: for regulatory approval)

• Parallel Groups (e.g., long half life drugs, patients)
  
• Cross-over (standard 2×2, replicate: at least on formulation administered more than once, higher order: more than two formulations)

• single dose
  
• multiple dose (pseudo steady state)

• Fasting state
  
• Fed state (high-fat / high-calory or standard meal)

• Food (single dose)
  
• PK (other drugs; in steady state)