Question
Pharmaceutical Management Question on Standard institutions and regulatory authorities
Which of the following ICH Harmonized Tripartite Guidelines related to stability, provides approaches that allows for bracketing and matrixing designs for stability testing. This is especially important when a new drug product is to be commercialized with multiple strengths in multiple packaging configurations.
A
Q1F
B
Q1D
C
Q1B
D
Q1A
Answer
Q1D
Explanation
Solution
The correct option is (B): Q1D