The guidance details on below pointers:

  1. 1. General BE Principles: Rate and extent of absorption should not show significant difference from listed drug at same molar dose under similar conditions.
  2. 2. Study Design: Study populations (healthy vs. patients, age, sex), study types (single/multiple dose, crossover/parallel, replicate), sample size, fasting vs. fed conditions
  3. 3. Replicate Design: Partial or fully replicate crossover for highly variable drugs or narrow therapeutic index drugs; uses fewer subjects than non-replicate.
  4. 4. Fasting vs. Fed: Both fasting and fed BE studies recommended for all oral IR and MR products unless serious adverse events anticipated.
  5. 5. Post-Approval Changes: Compare post-change product to RLD (not pre-change); in vitro comparison recommended generally.
  6. 6. Study Population: Include similar male/female proportions; include subjects ≥60 years if drug for elderly; adult BE can support pediatric assessment.
  7. 7. Other aspects like new dosage forms, handling outliers, etc.

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Source
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioequ…
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