Basic Principles and Drug Development

Pharmacokinetics

what the body does to the drug

Pharmacodynamics

what the drug does to the body

What are the two effects that a drug must have for clinical pharmacology?

beneficial or therapeutic

Drug

a substance that interacts with living systems through chemical processes and alters physiologic function

Pharmacogenetics

study of genetic basis for drug responses especially person-to-person variation

Toxicology

study of harmful effects of chemicals

How is the generic name different from the trade name?

Generic is often derived from chemical name and trade given by the individual manufacturer

What is a bioequivalent drug?

Same type and amount of active ingredient(s), administration route, pharmacokinetics, and therapeutic effects

How may a bioequivalent drug be different then its generic counterpart?

May have different inactive ingredients

Orphan drugs

drugs that treat rare diseases

On average, how long from start to finish does it take to get a drug from in vitro studies to new drug applications?

8-9 years

During phase 2 of clinical testing, what is the main question being tested?

Does it work in patients?

What is phase 4 of the clinical testing process?

Postmarketing surveillance

Side-effect

unwanted, undesirable effect of a drug, usually referring to effects occurring within therapeutic range

What are other names for a side-effect?

Adverse effect or adverse reaction

Toxic effect

deleterious and undesired effect of a drug usually referring to enhanced drug effects

Threshold dose

dosage when an effect begins to occur

What does a dose-response curve tell us?

Range of effective doses, maximal effect, threshold dose

Efficacy

ability of drug to produce a functional response

Potency

the dose needed to produce a given response

What is drug potency compared to?

EC50

What is the drug efficacy compared to?

Emax

Emax

concentration of drug producing maximal effect

EC50

concentration of drug producing 50% of maximal effect

If a drug has a higher ceiling effect, what would this mean?

More efficacious

If a drug requires lower dosage to reach a maximal effect, what would this mean about the drug?

More potent

ED50/Median Effective Dose

dose at which 50% of the population responds to the drug in a specified manner

TD50/Median Toxic Dose

dose at which 50% of the population exhibits a specified toxic or adverse effect

Therapeutic index

measure of beneficial vs toxic effects

How is therapeutic index calculated?

divide the median toxic dose by the median effective dose

Would a drug with a lower or higher therapeutic index be safer?

High TI is safer

If there is an overlap of therapeutic window and potential adverse effects, what does this mean about the therapeutic index?

Small therapeutic index

Off-label prescribing

prescription of a drug to treat conditions other than those that the drug was originally approved to treat

Over-the-counter drug

drugs that a consumer can purchase directly

Controlled substances

drugs with additional restrictions due to their potential for abuse

Schedule I

highest potential for abuse, not generally used medicinally

What are examples of schedule I drugs?

Heroin, LSD

Schedule II

legal for medicinal use, but high potential for abuse and addiction

What is an example of a schedule II drug?

Morphine

Schedule III

likelihood of mild to moderate physical or strong psychologic dependence

What is an example of a schedule III drug?

codeine combined with nonopioid

Schedule IV

limited possibility of dependence

What is an example of a schedule IV drug?

Some antianxiety drugs

Schedule V

lowest abuse potential

What is an example of a schedule V drug?

opioid cough medicine