Question

drexel has discovered a new fictitious compound called Edistatin, a Low-Chol, they believe has promising pharmacologic benefit. A patent was granted for the compound, and all of the required animal testing was submitted to the FDA with the IND application. The FDA gave approval to proceed with human testing. Construct a one-page summary of what you think should be the required studies Phase I, II, and III to submit in the NDA. For each phase, include the objective of the study (studies), type of subjects selected, outcomes measures (i.e. cholesterol reduction and safety), and results. Be creative!! We are interested in your approach based upon your readings.

Background: Assume that the effective dose is 10 and 20 mg. The safety profile is that of other statin products such as Lipitor, etc.

Answer 1

After FDA approval the drug needs to be tested on the animals where the safety points to be noted. Also researchers will record pharmacodynamics and pharmacokinetics of the compound. Here we got the approval from the FDA.

To conduct clinical trials on human being we need to go phase by phase. First we should plan a study design whether it is double blinded, single blinded, randomized or cross over study for phase II Phse III trials.

There are three phases of clinical trials to submit NDA to FDA

Phase I

Objectives: To evaluate the safety of the drug..

Types of subjects : Healthy volunteers (No vulnerable population) small population 20-100

Outcome measures: Here they will check Cmax, Tmax and tolerable dose. Check effects of the drug on humans including how it is absorbed, metabolized, and excreted.T his phase also investigates the side effects that occur as dosage levels are increased

It takes several months to complete

Phase II

Objectives: To test the efficacy of a drug

Types of subjects: Test on patients (Hypercholestermia), hundres of population will be involved, here we will go with randomization method. It will have experimental and control group

Experimental drug is Edistatin, Control drug is Lipitor

Outcome measures: Check blood cholesterol levels

It takes months to two years

Phase III

Objectives: It involves randomized and blinded testing, to see effectiveness of the drug, the benefits and the range of possible adverse reactions on large population

Types of subjects: Thousands of hypercholesteremia patients in multiple centers/across the world

Outcome measures: To check for Adverse drug reactions and efficacy of the dryg by testing the cholesterol level as it should go down if the drug is effective

It can lasts for several years

Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug.