Rug discovery and Developmental Assignment

1. Prepare a report on the discovery and developmental of a theoretical new drug which will be marketed internationally. Choose one of the following infectious diseases as the target for your new drug.
a. HIV/AIDS
b. Tuberculosis
c. Malaria

2. Include the following in your report
a. Discovery (10marks)
i. Approaches used for identifying the lead compound (3 marks)
ii. Likely sources of compounds (2 marks)
iii. Likely assays for screening (2 marks)
iv. Proposed timeline (1 mark)
v. Proposed criteria for selecting the lead compound for preclinical development (2 marks)

b. Preclinical development (20 marks)
i. In Vitro assays (5 marks)
ii. Animal efficacy studies (5 marks)
iii. Toxicology studies (2 marks)
iv. Pharmacokinetic studies (2marks)
v. Proposed timeline (1 marks)
vi. Criteria for the decision to proceed into clinical development (5 marks)

c. Clinical development (70 marks)
i. Phase 1 studies including:
1. Study design and aims (5 marks)
2. Likely subjects (2 marks)
3. Proposed timeline (1 mark)
4. Criteria for proceeding to Phase II (2 marks)

ii. Phase II studies including:
1. Study design and aims (10 marks)
2. Likely subjects (4 marks)
3. Proposed timeline (1 mark)
4. Criteria for proceeding to Phase III (5 marks)

iii. Phase III studies including:
1. Study design and aims (20 marks)
2. Likely subjects (4 marks)
3. Proposed timeline (1 mark)
4. Criteria for proceeding to Phase III (5 marks)
iv. Phase IV studies including:
1. Study design and aims (5 marks)
2. Likely patients (5 marks)