5 SAFETY EVALUATION 5.1 Identify adverse events observed (List any adverse events by subject number. State whether a reaction occurred following administration of the test or reference product, identify any causal relationships, and note any treatments required. State location of this summary in the submission.) (Discuss the implications of the observed adverse events with respect to bioequivalence.) 5.2 Comments from review of Section 5 NAFDAC use only – 6 EFFICACY EVALUATION 6.1 Presentation of data State location in submission of tables of mean and individual subject concentrations State location in submission of (mean and individual) linear and semi-logarithmic subject drug concentration vs. time plots
5 SAFETY EVALUATION 5.1 Identify adverse events observed (List any adverse events by subject number. State whether a reaction occurred following administration of the test or reference product, identify any causal relationships, and note any treatments required. State location of this summary in the submission.) (Discuss the implications of the observed adverse events with respect to bioequivalence.) 5.2 Comments from review of Section 5 – NAFDAC use only 6 EFFICACY EVALUATION 6.1 Presentation of data State location in submission of tables of mean and individual subject concentrations State location in submission of (mean and individual) linear and semi-logarithmic subject drug concentration vs. time plots
BTIF-NAFDAC2240326411.docx