Bioequivalence and Bioavailability Forum

HVDP RSABE (FDA) and ABEL (EMA) [RSABE / ABEL]

posted by khaoula – Algeria, 2014-05-23 17:37 (4418 d 02:38 ago) – Posting: # 12997
Views: 7,201

Dr Mr,
I have read à lot of guidelines and Draft of(FDA, EMA)and some articles but I do not have access to lot of papers such as http://www.ncbi.nlm.nih.gov/pubmed/22162308 , so I can't understand for FDA approach application of SABE The test formulation is judged to be SABE with the reference product if the upper 95% confidence limit is <0 and after applie the TOST for the new limits or no, thank you

Complete thread:

• HVDP RSABE (FDA) and ABEL (EMA) khaoula 2014-05-20 19:18 
  • HVDP RSABE (FDA) and ABEL (EMA) d_labes 2014-05-22 14:24
    • HVDP RSABE (FDA) and ABEL (EMA)khaoula 2014-05-23 15:37
      • Some hints Helmut 2014-05-23 17:11
        • Some hints ElMaestro 2014-05-23 18:34
          • Maths dummy Helmut 2014-05-23 23:44
        • Some hints khaoula 2014-05-23 20:56