Clinical Research Assignment
Budget: €30 – €250 EUR
Instructions:
Part 1: For the drug product and therapy area of your choice:
https://www.ema.europa.eu/en/medicines/download-medicine-data#european-public-assessment-reports-(epar)-section
Please provide the following:
1. Overview of therapeutic area and outline drug description: active substance of the drug – what is made of? What is drug used for?
2. PD/PK (ADME) of the drug.
3. Safety information and side effect of the drug
Part 2: Review the ICH Safety Guidelines (e.g. ICH S1A, ICH S2, ICH S3A..) https://www.ich.org/products/guidelines.html
1. Select TWO ICH Safety guidelines and research in the non-clinical safety studies.
2. Give an overview of the requirements of the two selected safety guidelines.
3. Explain in your own word: What type of tests you would recommend to conduct for the drug product of your choice (in compliances with the ICH Safety Guidelines), and why?
Part 1: For the drug product and therapy area of your choice:
https://www.ema.europa.eu/en/medicines/download-medicine-data#european-public-assessment-reports-(epar)-section
Please provide the following:
1. Overview of therapeutic area and outline drug description: active substance of the drug – what is made of? What is drug used for?
2. PD/PK (ADME) of the drug.
3. Safety information and side effect of the drug
Part 2: Review the ICH Safety Guidelines (e.g. ICH S1A, ICH S2, ICH S3A..) https://www.ich.org/products/guidelines.html
1. Select TWO ICH Safety guidelines and research in the non-clinical safety studies.
2. Give an overview of the requirements of the two selected safety guidelines.
3. Explain in your own word: What type of tests you would recommend to conduct for the drug product of your choice (in compliances with the ICH Safety Guidelines), and why?