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Buprenorphine extended‑release PSG: in vitro BE options and scale guidance
Summary
Using buprenorphine extended‑release injectables as an example, the presenter explained in‑vitro BE eligibility conditions, Q1/Q2 considerations, and footnoted manufacturing‑scale recommendations for pivotal studies.
The presenter used buprenorphine extended‑release (polymer‑based, in situ) as a case study and said PSG sections are designed to give an overview and a quick summary of recommended approaches so applicants can identify suitable BE pathways without reading every detail.
On in‑vitro BE options, the presenter said eligibility often depends on formulation preconditions such as Q1/Q2 sameness where regulation requires it; however, non‑Q1/Q2 formulations might still be considered if the sponsor provides justification and discusses the approach with the agency. “If the product itself by regulation has to be q 1 q 2 the same, then that usually is our criteria,” the presenter said.
The presenter also noted that PSG footnotes address manufacturing scale; for products where later scale‑up could create issues, the PSG may recommend commercial‑scale batches for BE studies. He clarified that when the PSG labels a study as a pivotal in‑vitro BE study it is treated as pivotal (retention samples required) rather than simple characterization.
