CLINICAL PHARMACOLOGY ARAVIND – 09901366442 – 09902787224
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ARAVIND – 09901366442 – 09902787224
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 more and more necessary to have multidisciplinary
specialist approach in planning & Conducting clinical trials. The team conducting the
clinical trial usually consist of the principal investigators, the company investigators and
the clinical research associates (CRAS). The clinical Research Coordinators (CRC’S)
because Dr. Reddy knows the CRC and CRA are like the two pillars of any
critical trial and they are the key members who ensure that the data is
obtained faster and is clean.
Questions:-
Q.1) Define CRC
Q.2) Define CRA
Q.3) Who can be
appointed as a CRC/CRA?
Q.4) Elaborate
the responsibilities of the CRC and CRA?
CASE STUDY: 4
Fraud and
misconduct in clinical research has received intense attention in medical
field, literature and media in the recent years. Dr. Rajesh was working with
Damur India Limited as a chief nutritionist. He started working on the project
of effectiveness of multivitamin in improving cognitive dysfunction in elderly
patients. In 2006, he allegedly produced fraudulent data on the effectiveness
of multivitamin in improving cognitive dysfunction in elderly patients.
Questions:-
Q.1) What is the
definition of fraud and misconduct in clinical research?
Q.2) According to
you what are the steps and procedures adopted by Mr. Kunte to investigate
fraud?
Q.3) What are the
penalties you can suggest to Dr. Kunte for proven fraud and misconduct?
Q.4) Explain the
responsibilities of Dr. Kunte as an investigator in the Whole process.
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