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• Understand the clinical trial phases, 1 to 4
• Understand the different ways a clinical trial can be run, and the different types of controls

Workshop 2:

Phases of drug development, before and after nonclinical approval (IND) and before and after marketing approval (NDA)

Drug study designs, read http://www.fda.gov/RegulatoryInformation/Guidances/ucm126501.htm

Clinical trials and their phases explained by the FDA http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ParticipatinginClinicalTrials/ucm129557.htm

Clinical trials and their phases explained by clinicaltrials.gov, http://clinicaltrials.gov/ct2/info/understand

CDER Learn has several tutorials explaining the regulatory process, access them from http://www.fda.gov/Training/ForHealthProfessionals/default.htm.

Product recalls video: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm182929.htm.

Download and look through the FDA manual "APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS" here.

Assignment 2:

1. Go to FDA.gov and list marketed, approved drugs that target for at least 5 indications of cardiovascular disease which may include acute or chronic symptoms of hypertension, cholesterol, obesity, heart failure, fibrillation. Pick a drug used for acute CVD, and a drug used for chronic CVD.

2. Summarize the drug development cycle for these drugs. Use a diagram and explain it in the text.

3. Find the websites for the companies that market your 2 drugs. Find out if they are marketed in Europe, in Asia. Find out how to get the drug if you are a health professional in one or more of  a) Nairobi, b) Cairo c) Accra

4. If this topic has really interested you, and you have found out something you did not know, chances are you have created knowledge, and what you have found could be published in an essay in MJoTA.

Quiz 2

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