Phases of Drug Development – Absorption and Distribution | Pharmacokinetics (PK)

by Pravin Shukle, MD

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    Okay, let's talk about something a little bit different. Let's talk about phases of drug development. So this mythical pharmaceutical company called Gargantua Pharmaceuticals has developed an eye drop that can give humans X-ray vision. So far rats have been able to see cheese through solid walls. And dogs can see chew toys through sheets of plywood. Okay sounds like a fun drug. The chief executive officer comes to you and wants to know what is the next phase of drug development. Is it phase 1, 2, 3 or 4. In order to answer this question let's go through what the different phases are. So when we are testing a drug we talk about the pre-clinical phase. This is where we do in vitro testing in little test tubes and little beakers. And then we go on to animal testing and then animal safety testing. That's the preclinical phase. Then we move on to the clinical phase which is in human, phase 1, 2, 3, and 4. When we talk about in vitro testing we're really talking about various chemical parameters. We measure pKa, we measure tissue stability, tissue binding. Whether or not a drug in sensitive to light or not. Whether or not it will actually leech into the plastic of a pill container. All kinds of things are tested at this stage of development. We do environmental testing because we want to know if this drug is dropped into the sewer, is it going to cause damage to fish and to wildlife. And we do stability testing. Whether it's hot temperatures, if you leave the drug on the dash of your car, or if you accidentally let it freeze in a cold climate. Animal testing is always tested on at least two species. We test acute toxicity and...

    About the Lecture

    The lecture Phases of Drug Development – Absorption and Distribution | Pharmacokinetics (PK) by Pravin Shukle, MD is from the course Pharmacokinetics and Pharmacodynamics.

    Included Quiz Questions

    1. The drug has been tested on pregnant animals with no evidence of harm, but there are no studies looking at women.
    2. The drug has shown no evidence of harm in the first trimester.
    3. The drug has been shown to cause harm in pregnant women.
    4. The drug was tested on animals with evidence of teratogenicity, but there are no studies in women.
    1. The drug will now be tested through multi-centered trials with and without the disease evaluating for effectiveness in comparison to older therapy and for rare adverse reactions.
    2. The drug is now ready to be used in the marketplace, with physician surveillance to evaluate for adverse events.
    3. The drug has undergone testing in a trial of 200 healthy volunteers and will now be tested in patients with disease, with pharmacokinetic and eutectic studies to determine various chemical and pharmacological parameters.
    4. The drug has undergone in vitro studies, has passed in vivo studies on two animal species, and is now ready for a study in healthy male volunteers without disease.
    1. Testing on healthy human volunteers
    2. Environmental testing
    3. Chemical parameter determination
    4. Toxicity testing in rats
    5. Stability testing
    1. No controlled studies have been shown in women.
    2. No fetal risk in animals.
    3. No harm has been shown in women in controlled studies.
    4. Only in vitro testing has been performed at this stage.
    5. Teratogenic effect shown in animals.
    1. Phase 4
    2. Phase 3
    3. Pre clinical
    4. Phase 1
    5. Phase 2

    Author of lecture Phases of Drug Development – Absorption and Distribution | Pharmacokinetics (PK)

     Pravin Shukle, MD

    Pravin Shukle, MD

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