According to ICH stability guidelines (Q1A), what is the minimum duration of long-term stability testing for a drug intended for Zone IVB (hot and very humid) before marketing approval?
A. 3 months
B. 6 months
C. 12 months
D. 12 months long-term + 6 months accelerated
A liquid formulation of an antibiotic shows a shelf life of 6 months at 25 °C. If the degradation follows first-order kinetics with an activation energy of 60 kJ/mol, how will its shelf life change if stored at 35 °C? (Use Arrhenius equation approximation: shelf life halves for every 10 °C rise when Ea ≈ 50–70 kJ/mol)
A. ~3 months
B. ~4 months
C. ~6 months
D. ~12 months
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C
A
D
A
C
A
1. C
2. A
C
A
C
A
D
A