Pharm- Intro To Pharm

Question 1

Drugs

Answer 1

-Substances that change biological function (in subject/ organism through chemical action. -FDA definition- Substance intended for use in diagnosis, cure, tx, prevention of disease.

Question 2

Drug Regulation- FDA

Answer 2

-enforce federal food, drug, cosmetic act. -oversee drug eval process

Question 3

CEDR

Answer 3

• Center for Drug Evaluation and Research -ensure drugs for humans safe and effective

Question 4

IND (investigational ew drug)

Answer 4

-submitted before human clinical trials -exemption to allow transport across state lines for trials -required for: new indication, change in promotion/ population or risk to pop./ route of admin or dosage

Question 5

NDA (new drug application)

Answer 5

-drug company proposes FDA approve new drug for sale and marketing in US -provide this info: drug safe and effective for proposed use, proposed labeling appropriate in what it should contain, methods used in manufacturing preserves drug identity/ strength/ quality/ purity ** 0 drugs on market 100% safe **

Question 6

ANDA ( abbreviated new drug application) “abbreviated”- not required to show clinical data regarding safety/ efficacy

Answer 6

-filed after patent expires -review of generic drug -demonstrate products bioequivalence ( same chemical properties/ action -comparable to branded drug in: dose form, strength, RoA, quality, performance, intended use

Question 7

Drug nomenclature

Answer 7

• generic name: common name ** - trade name: brand name

Question 8

Generic name examples

Answer 8

-oxetine: antidepressants related to fluoxetine -sartan: angiotensis II receptor antagonists -oxacin: antibiotic derivatives of quinolone -vir: antiviral compounds

Question 9

Pharmacology

Answer 9

-study of substances interact with living systems through chemical processes (activate/ inhibit normal body processes) -medical pharm: science of substances used to prevent, dx, tx diseases

Question 10

Pharmacokinetics

Answer 10

-what body does to drug -Liberation; drug release -Absorption: drug enters circulation -Distribution: drug movement thru body -Metabolism: transformation of parent compound -Excretion: drug removal from body

Question 11

Pharmacodynamics

Answer 11

-what drug does to body -drug concentration at site of action and degree of effect produced

Question 12

Pharmacogenomics

Answer 12

-variation in drug response due to gene variation -metabolism (transformation of parent compnd) effected: -poor: highest serum -extensive: expected serum -ultra sensitive: lowest serum

Question 13

Drug Development: time line

Answer 13

Question 14

Phases of clinical trials

Answer 14