question

Penicillin was first synthesized in the 1930's. What other drugs were also first produced at this time?

answer

Sulfonamides and Insulin

question

In what year did we see an explosion in the amount of synthetic drugs produced?

answer

1950

question

What two drugs are most well-known as drugs produced and patented by universities?

answer

Warfarin (Anticoagulant) Cisplatin (Chemotherapy drug)

question

What are the two approaches to Drug Discovery?

answer

1) Forward Pharmacology 2) Reverse Pharmacology

question

Which one came before the other between Forward and Reverse Pharmacology?

answer

Forward

question

What steps are involved in Forward Pharmacology?

answer

1) Discovery of compound 2) Development of assays to determine biological activity 3) Determine mechanism of action

question

What steps are involved in Reverse Pharmacology?

answer

1) Isolate a therapeutic target (e.g., beta-adrenergic receptor) 2) Identify a compound that affects the target 3) Modify the drug structurally to maximize beneficial effects and minimize deleterious effects 4) Demonstrate the desired effect in vivo

question

Which one, Forward or Reverse Pharmacology, is cell or physiologically-directed?

answer

Forward Pharmacology

question

Which one, Forward or Reverse Pharmacology, is unbiased regarding the mechanism of action?

answer

Forward Pharmacology

question

Which one, Forward or Reverse Pharmacology, do you need to determined the mechanism of action in vivo and in vitro?

answer

Forward Pharmacology

question

Which one, Forward or Reverse Pharmacology, is molecularly target-directed?

answer

Reverse Pharmacology

question

Which one, Forward or Reverse Pharmacology, involves already demonstrating in vitro activity and a need to demonstrate in vivo activity?

answer

Reverse Pharmacology

question

The drug targets of most current therapies are what?

answer

Receptors (45%) Enzymes (28%)

question

Aside from receptors/enzymes, what are other biochemical classes of drug targets?

answer

Hormones Ion channels Nuclear Receptors (RNA/DNA)

question

What are the stages of new drug development?

answer

1) Early research and preclinical testing 2) Submission of IND application 3) Submission of NDA

question

What is IND? How many phases are involved? Each phase involves what?

answer

Investigational New Drug (IND) Three - Phase I, II, and III A clinical trial

question

What is an NDA and who approves it?

answer

New Drug Application (NDA) FDA

question

The first stage of new drug development involves what?

answer

In vitro studies

question

When do Phase IV clinical trials start? What do you call Phase IV?

answer

Once the FDA approves the NDA Phase IV = Post-Marketing Surveillance

question

The drug development stage that involves in vitro studies leads to the production of what?

answer

Lead compound

question

The lead compound typically produced during in vitro studies can come from what two sources?

answer

biological products (natural) chemical synthesis

question

How long is the drug development stage that involves in vitro studies?

answer

About 1 year

question

After being done with in vitro studies, you have a lead compound. What will now happen to the lead compound as you move into the next stage of new drug development?

answer

Test efficacy, selectivity, and mechanism in animal models

question

If after testing in animals, your data comes back promising. What will now be the next step in drug development?

answer

Submit an IND to the FDA

question

If the FDA approves of your IND, what can now commence?

answer

Phase I, II and III clinical trials

question

What is the primary research question in Phase I clinical trials (new drug development)?

answer

Is the drug safe?

question

What is the primary research question in Phase II clinical trials (new drug development)?

answer

Does the drug work?

question

What is the primary research question in Phase III clinical trials (new drug development)?

answer

Does the drug work in a randomized control trial that is also a double-blind study?

question

During the clinical trial (phase I, II, and III) stage of drug development, you are also actively doing what?

answer

Researching the mechanism of drug metabolism and assess drug safety.

question

What happens after Phase III clinical trials (new drug development) are complete?

answer

You file an NDA (New Drug Application) with the NDA

question

The new drug application is usually submitted how long after the initial studies?

answer

8-9 years

question

If the new drug application is successful, what happens?

answer

The drug is then marketed to physicians and other clinicians. Phase IV can also begin.

question

On average, how long after a patent is filed will it expire (generics become available)?

answer

17 years

question

What is the average amount of time alotted to early research and preclinical testing (new drug development)?

answer

6.5 years

question

Early research and preclinical testing is often done where and using what models (new drug development)?

answer

In the laboratory, using animal models.

question

What is typically the primary goal when it comes to early research and preclinical testing (new drug development)?

answer

To assess safety and biological activity

question

What is the average length of time for Phase I clinical trials to be complete?

answer

1 year

question

Usually, how many and what kind of volunteers are recruited for Phase I clinical trials?

answer

About 20-80 HEALTHY volunteers, with the exception of testing of HIV or cancer drugs

question

What is typically the goal for Phase I clinical trial tests?

answer

To assess dosage and safety.

question

What is the average length of time for Phase II clinical trials to be complete?

answer

2 years

question

What is typically the goal for Phase II clinical trial tests?

answer

Assess effectiveness and determine side effects (if any)

question

Usually, how many and what kind of volunteers are recruited for Phase II clinical trials?

answer

100-200 patient volunteers

question

What is the average length of time for Phase III clinical trials to be complete?

answer

3-4 years

question

What is typically the goal for Phase III clinical trial tests?

answer

To verify effectiveness and monitor adverse reactions from long-term use.

question

Usually, how many and what kind of volunteers are recruited for Phase III clinical trials?

answer

1000-3000 patient volunteers

question

Review of NDA and approval by FDA can take as long as what?

answer

1.5 years

question

Why is Phase IV so important?

answer

After the drug has been approved for marketing, it is important for researchers to monitor any side effects of the drugs. If side effects are uncommon (1/100,000), Phase I-III will not have enough subjects for such a side effect to surface.

question

As many as how many compounds can be evaluated during preclinical testing?

answer

5000

question

How many compounds usually enter clinical trials?

answer

5

question

From the initially lot of 5000, the NDAs of how many compounds are usually approved by the FDA?

answer

1

question

What is the success rate for new drugs - from the time it underwent preclinical trials to it being approved for marketing by the FDA?

answer

11%

question

In what continent do we see the most use of drugs (determined by sales of prescription drugs)?

answer

North America

question

The IRB will only approve the use of human subjects if what requirements are met?

answer

1) The drug has acceptable benefit to risk ratio 2) The informed consent is appropriate 3) The procedures are appropriate 4) The research design is appropriate

question

When are new drugs typically tested in pregnant women?

answer

After marketing (approved by FDA). For this reason, there is a disclaimer on medication for pregnant women about inadequate human testing and benefits outweighing the risks.

question

What are the five categories for pregnancy medication established by the FDA?

answer

Category A, B, C, D, X

question

A Category B indicates that a drug for use during pregnancy will have what risk(s) to the fetus/person taking it?

answer

There are no risks in animal studies, but there are no human studies to confirm.

question

A Category D indicates that a drug for use during pregnancy will have what risk(s) to the fetus/person taking it?

answer

There is demonstrated risk to the fetus, but the person may continue taking it despite the risk.

question

A Category X indicates that a drug for use during pregnancy will have what risk(s) to the fetus/person taking it?

answer

The risks of taking the drug outweighs any benefits.

question

A Category A indicates that a drug for use during pregnancy will have what risk(s) to the fetus/person taking it?

answer

Controlled studies on pregnant women have shown no risks.

question

A Category C indicates that a drug for use during pregnancy will have what risk(s) to the fetus/person taking it?

answer

Adverse fetal effects in animals, but can be used if the benefits outweighs the risks

question

Can children be used as subjects in drug development studies?

answer

Yes, but children have not been used as subjects historically.

question

What is the FDA Modernization Act of 1997?

answer

Also known as FDAMA. It provides incentives in the form of patent extension for drug companies to test new drugs on children (so that we know what the effects are on children).

question

The Pediatric Rule of 1998 demands what?

answer

That studies involving children should be conducted unless there is a valid reason not to do so.

question

Are elderly adults used as test subjects in new drug studies?

answer

Historically, they have been excluded, but are now included in studies - especially those that the elderly are the target population (Alzheimer's, Heart Failure, etc.).

question

The FDA place what kind of regulation(s) on dietary supplements?

answer

Voluntary Post-market Adverse Reaction Reporting (Voluntary) Some safety-related labeling required

question

The FDA place what kind of regulation(s) on conventional food items?

answer

Same as dietary supplements

question

The FDA place what kind of regulation(s) on food additives?

answer

Premarketing approval required Voluntary Post-market Adverse Reaction Reporting (Voluntary) Some mandatory Post-marketing Adverse Reaction Reporting Safety-related labeling required

question

The FDA place what kind of regulation(s) on over the counter drugs?

answer

Product regulation require Voluntary Post-market Adverse Reaction Reporting (Voluntary) Safety-related labeling required

question

The FDA place what kind of regulation(s) on NDA drugs?

answer

Product regulation require Premarketing approval required Voluntary Post-market Adverse Reaction Reporting (Voluntary) Mandatory Post-marketing Adverse Reaction Reporting Safety-related labeling required

question

The FDA place what kind of regulation(s) on infant formulas?

answer

Product regulation required Voluntary Post-market Adverse Reaction Reporting (Voluntary) Mandatory Post-marketing Adverse Reaction Reporting Safety-related labeling required

Pharmacology Week 1: Drug Development – Flashcards

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