Pda Technical Report 27 Pdf -

TR 27 was revolutionary because it classified testing methods into two categories:

For many years, the original TR 27 (often cited from the late 90s or early 2000s) was the standard. However, regulatory bodies like the FDA and EMA began requiring more rigorous, science-based data than older probabilistic methods could provide. pda technical report 27 pdf

Yes, but only if your validation data supports it. The FDA prefers current standards, so you may be asked to justify why you are not using TR 84. TR 27 was revolutionary because it classified testing