1
Q
Quality topics
A
Topics relating to pharmaceutical and chemical quality assurance
2
Q
Safety topic
A
Topic relating to invitro and invivo pre clinical studies
3
Q
Efficacy topics
A
Topics relating to clinical studies in human subjects
4
Q
Multidisciplinary topics
A
Cross cutting topics which do not fit uniquely in any of the above categories
5
Q
Quality topic example
A
Q1 : STABILITY TESTING
Q3: Impurity testing
6
Q
Safety topic example
A
S1: carcinogenecity testing
S2: genotoxicity testing
7
Q
Efficacy testing example
A
E4: dose response studies, carcinogenecity testing,E6: GCP
8
Q
Multidisciplinary topic example
A
M1 medical terminology(medDra)
M3 timing of pre clinical studies in relation to clinical trials
