What are the proposed changes in the REPORTABLE RANGE as per the Draft ICH guideline -Q2(R2)
12:15
What are the proposed changes in specificity/selectivity as per the Draft ICH guideline -Q2(R2)
12:26
What are the differences in method validation between ICH and ANVISA?
13:47
Hardy's Integral
26:07
How to define limit for unknown, known and total impurities
17:16
How to define the acceptable %RSD for precision study?
11:46
LINEARITY (ICH vs ANVISA)
20:35
What is significant change in the stability study?
22:27