Intro I and II, Drug Development Flashcards

1
Q

Define chemical name

A

specific compound’s structure; long

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2
Q

Define generic name

A

derived from chemical name; shorter-ish

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3
Q

Describe schedule I substance and examples

A

substances with no currently accepted medical use and high potential for abuse

Ex. heroin, LSD, marijuana, MDMA

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4
Q

Describe schedule II substances and examples

A

substances with a high potential for abuse w/ use potentially leading to severe psychological of physical dependence; accepted medical use

Ex. methylphenidate, methamphetamine, oxycodone, morphine, methadone, hydromorphone, fentanyl, cocaine

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5
Q

Describe schedule III substances and examples

A

moderate to low abuse potential compared to schedule II

Ex. anabolic steroids, testosterone, codeine, ketamine

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6
Q

Describe schedule IV substances and examples

A

Schedule IV: lower abuse potential and risk of dependence compared to schedule III

Ex. diazepam, lorazepam, phenobarb, propoxyphene, tramadol

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7
Q

Describe schedule V substances and examples

A

lowest abuse potential

Ex. low dose opioids in cough meds, lamotil, pregabalin

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8
Q

Define pharmacokinetics (PK). What is it composed of?

A

what the body does to the drug

absorption, distribution, metabolism, excretion (ADME)

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9
Q

Define pharmacodynamics (PD). What is it composed of?

A

what the drug does to the body

MOA, dose response, effects, SE

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10
Q

Describe absorption, passive diffusion

A

H2O and water soluble substance and small lipids move w/ concentration gradient

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11
Q

Describe absorption, active transport

A

minerals, some sugars, and most amino acids move against a concentration gradient w/ an input of energy

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12
Q

What factors affect distribution

A

-tissue permeatbility
-BF
-binding plasma proteins
-binding to subcellular components

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13
Q

What organ is a major site of drug elimination?

A

kidney

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14
Q

Define clearance rates for excretion

A

ability of all organs and tissues to eliminate drug or ability of single organ/tissue to eliminate drug

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15
Q

Define half-life of excretion

A

amount of time required for 50% of drug remaining in body to be eliminated

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16
Q

Phase I drug metabolism; what happens and what is involved

A

oxidation (CYP 450) and reduction

polar (water soluble) metabolite often still active

17
Q

Phase II drug metabolism; what happens

A

conjugation of reactive groups inserted in phase I

large polar metabolite by adding endogenous hydrophilic groups to form water-soluble inactive compounds

18
Q

Components of phase II drug metabolism

A

Glucuronidation, sulphate, glycine, acetylation, methylation

19
Q

Define bioavailability

A

amount of substance that enters the bloodstream and is available for the body to use

20
Q

Define bioequivalence

A

two different versions of a drug that work the same way

21
Q

What are major organs of drug metabolism and excretions?

A

liver and kidneys

22
Q

What factors affect the variations to drug response?

A

-disease
-genetics
-age
-diet
-gender
-drug interactions
-environmental
-obesity
-exercise
-cigs/alcohol

23
Q

Define dose response

A

provides info about dosage range over which drug is effective

24
Q

Define potency

A

quantity of drug necessary to produce of given effect

25
Define efficacy
maximum response that can be achieved with a drug
26
Define median effective dose
E50 dose 50% of population responds to drug in specific manner
27
Define median toxic
T50 dose 50% of group exhibits AR's
28
Define median lethal dose
L50 dose causes death in 50% of the group; not used in human trials
29
Define agonist/full agonist
affinity or efficacy
30
Define partial agonist
do not evoke max response and does not fully activate receptor
31
Define antagonist
affinity only (but may have efficacy by inhibiting inhibitory neuron)
32
Define additive effects
2 chemical effects = sum of 2 chemicals taken separately
33
Define synergistic effects
2 chemical effects > sum of separate effect at same doses
34
Define tolerance, dependence, addiction
T: decreased rxn to drug after repeated use D: person dependent on drug to fx A: inability to control drug use
35
Describe the 3 main stages of the progress of drug development
-preclinical testing (animal trials provide info about PK and PD, dosage and toxicity) -human clinical trials -post marketing surveillance
36
What are the 4 phases of drug development
I: is it safe? PK? II: does it work? III: does it work double-blind? IV: post marketing surveillance
37
Define investigational new drug (IND), new drug app (NDA), FDA
Investigational new drug: a drug that is not approved by FDA New drug application: app to get approval from FDA Food and drug admin: approves drugs
38
List the various routes of admin (6)
oral, sublingual/buccal rectal, inhalation, injection, topical
39
Oral vs parenteral route of admin
parenteral skips 1st pass first pass: drug metabolized BEFORE reaching circulation (goes through digestive system)