PHAY0021 THE PROCESS OF DRUG DEVELOPMENT 2022Matlab

Java Python PHAY0021

THE PROCESS OF DRUG DEVELOPMENT (TPODD 2)

May 2022

1. Answer BOTH parts of the question

Your research company is developing a new drug and would like to proceed with the preclinical toxicology studies. They agree to start with a preliminary acute dose range finding study and have decided on an initial starting dose of 0.1 mg/kg body weight.

a) How would you carry out the preliminary dose range finding study and what considerations are needed when designing animal studies?  (50 % of marks)

It has been shown that the drug is metabolised by cytochrome P450 2D6 in vivo to form. a reactive species. The company are concerned about possible liver toxicity and mutagenic potential.

b) Discuss the reasons for their concern and the mechanism by which liver injury could occur following administration with this drug. Suggest one test you could carry out to determine if the drug is mutagenic.  (50 % of marks)

2. You are working as a pharmacovigilance scientist for a company developing a new biologic for a rare disease. Throughout PHAY0021 THE PROCESS OF DRUG DEVELOPMENT 2022Matlab the development process the company adopted a patient centric approach and are applying for orphan drug status. You have been asked to review the risk management plan which forms part of the regulatory submission.

Discuss the benefits of a patient centric approach for this drug and outline the importance of a risk management plan and the information that should be included in it. Give examples, where appropriate.  (100 % of marks)

3. Discuss the physicochemical properties you would consider as important for a lead optimisation process when you wish to optimise the absorption and distribution properties of a potent compound?   (100 % of marks)

4. Answer BOTH parts of the question

a) Explain, using examples, what you understand by the terms “conditional marketing authorisation” and “emergency marketing authorisation”, and make reference to the rolling review process.  (20% of marks)

b) Discuss the importance of conditional marketing authorisation for COVID-19 vaccines in reducing the burden of the disease and the impact that conditional marketing authorisation may have on the future regulatory marketing authorisations of medicines