Lecture 8+9: Toxicology

Question 1

Toxin

Answer 1

-poisonous substance from living thing

Question 1

Toxicology

Answer 1

-study of adverse effects of agents on living systems

Question 2

toxicant

Answer 2

man-made chemical introduced to environment

Question 3

Risk assessment

Answer 3

-regulatory toxicology (safety)
-mechanistic toxicology (why)
-descriptive toxicology (is it toxic)

Question 4

types of toxic responses

Answer 4

-local vs systemic
-immediate vs delayed
-reversible vs irreversible

Question 5

Phases of toxic response

Answer 5

-exposure
-disposition
-toxicodynamics

Question 6

Mitigation of toxic responses

Answer 6

-prevent exposure
-enhance elimination
-block/repair effects

Question 7

OAEL (observable adverse effect level)

Answer 7

-LOAEL: lowest
-NOAL: no

Question 8

LOAEL

Answer 8

-lowest observable adverse effect level
-lowest dose where toxicity starts

Question 9

NOAEL

Answer 9

-no observable adverse effect level
-highest dose at which no toxicity

Question 10

Variability in response

Answer 10

-resistant vs sensitive individuals
-set exposure levels where even sensitive individuals will be okay
-fuck pregnant ppl tho

Question 11

Toxicology and Public policy

Answer 11

-BAC

Question 12

Levels of risk-benefit analysis

Answer 12

-accessibility
-applicability
-acceptability

Question 13

Accessibility

Answer 13

FDA evaluates risk for population

Question 14

applicability

Answer 14

provider to patient

Question 15

acceptability

Answer 15

patient to self

Question 16

Investigational new drug (IND)

Answer 16

-filed after early discovery and preclinical development
-followed by 4 phases (NDA filed after phase III)

Question 17

elements required for IND

Answer 17

-animal pharma and toxicology
-manufacturing information
-clinical protocol and investigator information

Question 18

objective of preclinical toxicology studies

Answer 18

-limit risk to humans in administration of new agent

Question 19

preclinical studies

Answer 19

-acute (effect of one dose)
-repeated dose
-genetic toxicity
-reproductive toxicity
-carcinogenicity

Question 20

How to predict first dose of new drug

Answer 20

1. determine NOAEL in animal
2. calculate human equivalent dose (HED)
3. determine safety factor
4. divide HED by safety factor

Question 21

MRSD

Answer 21

-max recommended starting dose
-window between NOAEL and MABEL
-safety factor based on risk

Question 22

Minimal anticipated biological effect level (MABEL)

Answer 22

-guide first dose
-pharmacology instead of toxicology

Question 23

Why adverse effects are missed

Answer 23

1. rare events vs study participants
2. common events vs duration (age)