PHRM30008: Discovery to Market Drug Dossier- Report Writing Assignment

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Internal Code: TV157
Report Writing Assignment:

Task:

Drug dossiers are documents outlining the pharmacological details of a drug or drug class. Documents like this are routinely used in the pharmaceutical industry and, in a more informal way, good pharmacologists will keep a mental or written dossier of drugs that they are interested in.

For this task you will need to choose a drug from the following list:
• Carvedilol
• Diazepam

• Escitalopram
• Omalizumab
• Risperidone

• Rofecoxib
• Zidovudine

You will need to indicate your choice of drug by enrolling into a drug group through LMS. The number of places in each drug group is limited, so make your choice early! You will build your dossier by preparing answers to a series of questions. To do this, you will be required to research the literature, extract and interpret information, write scientifically, and appropriately acknowledge resources used in your research.

Drug Target & Mechanism of Action:
1. What is the primary molecular target and the mechanism of action of this drug? What was the rationale behind this choice of target?

Drug Characterisation – Pharmacokinetics & Pharmacodynamics:
2. How selective is the drug for its primary target? What other targets does the drug interact with? How important is the degree of selectivity for the therapeutic utility of the drug?
3. Are there physiological adaptations that contribute to, or modulate, the effects of this drug? How do these adaptations occur and what are their consequences?
4. How is the drug normally administered? What is the rationale behind this choice of route of administration?
5. What is the duration of action, plasma half-life, and normal dosing interval (frequency of administration) of this drug? How do these relate to one another?
6. What is the volume of distribution of this drug? What does this tell you about its possible distribution behaviour?
7. How is the drug eliminated? Discuss the metabolism and the mechanism(s) of excretion where appropriate.

Discovery & Optimisation:
8. Describe the process that was used in the discovery and development your drug. In your answer, consider the role of the following:
a) screening and/or structure based discovery;
b) in vitro assays in both the discovery and development phases;
c) animal models.

Clinical Assessment:
9. Provide an overview of the clinical trials that were undertaken for your drug. In your answer you may wish to consider:
i) the different clinical trial phases;
ii) trial design;
iii) clinical outcomes/endpoints;
iv) safety/adverse effects.

Uploaded By : jack
Posted on : February 09th, 2018
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