Lec 7

Question 1

What is is HPFB? what’s their mandate?

Answer 1

Health products and Food Branch
mandate: manage health-related risk and benefits of health products and food

Question 2

What is the steps in drug development process?

Answer 2

discovery + preclinical studies
clinical application + studies
new drug submission + regulatory review
approval / marketing authorization + post-market activities

Question 3

What does the preclinical phase of drugs focus on?

Answer 3

pharmacokinetics of drug
acute, chronic, reproductive, developmental, mutagenic toxicities and carcinogenicity

Question 4

what is the different amount of patients used in each phase of clinical studies? what’s the goal?

Answer 4

phase 1: <50 - safety
phase 2: ~100 - efficiently
phase 3: >1,000 - efficacy

Question 5

what is ICH?

Answer 5

international council for harmonization

make drug regulatory process more efficient in member countries