Clinical Pharmacology - What Is a Clinical Trial What Is the Process of Designing and Carrying Out Clinical Research Explain the Planning Steps of Mr. Simpson

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CLINICAL PHARMACOLOGY

CASE STUDY: 1

Rancip co. wants to discover and develop a new drug costs $ 800-1000 million and takes longer than 12 years. Clinical development the most important step prior to a drug entering the market takes 7 years. Each day’s delay in completing the drug development and launching the product in the market means a revenue loss of $ 1 million. So they appoint Mr. Kate as a project mager and the company expects the company expects the project management techniques to reduce this increasing cost and time pressure.

Questions:-

Q.1) What are the important responsibilities of Mr. Kate?

Q.2) What are the different stages Mr. Kate will use in the Process to set up the project and run it?

Q.3) On what elements will Mr. Kate focus?

Q.4) What are your Suggestions?

CASE STUDY: 2

IPTA lab discovered one drug on white cells and the company wants a clinical trial which is properly planned and executed for assessing the effectiveness of intervention, company appoints Mr. Simpson as a planner for above because company knows careful planning is required before the collection of data begins for conducting successful clinical research.

Now Mr. Simpson appoints two investigators who knows the planning process and to

recognize the difficulty encountered in studies with human subjects and planning any

clinical trial and attempt to estimate the magnitude of participant’s failure to protocol

compliance.

Questions:-

Q.1) What is a clinical trial?

Q.2) What is the process of designing and carrying out clinical research?

Q.3) Explain the Planning Steps of Mr. Simpson.

Q.4) What are the important considerations to conduct of any type of clinical trial?

CASE STUDY: 3

Dr. Reddy is a leading pharma company; they discover lot of new products or drugs in

last 20 years. Over the years it has become...