NUSCTX 11, Final - UC Berkeley UPDATED
ACTUAL Exam Questions and CORRECT
Answers
Preclinical Development - CORRECT ANSWER - 6-7 years of preclinical testing
Manufacturer completes synthesis and purification of the drug and conducts animal testing
Of 5000 compounds tested, ~5 will appear promising enough for a company to file an
Investigational New Drug Application
If the IND is approved, then the company can begin Phase I clinical trials
Essential Pharmaceutics - CORRECT ANSWER - Structural characterization
Impurity identification
Solubility assessment
Prototype formulation
Stability testing
Screening Efficacy - CORRECT ANSWER - In vitro models
In vivo models
Other
Early ADME - CORRECT ANSWER - In silico profiling
Develop simple analytical method
Measure membrane permeability
Plasma stability
, Early toxicology - CORRECT ANSWER - Off target screen
In vitro cytotoxicity
Preliminary AMES
hERG binding
ADME/PK - CORRECT ANSWER - Test materials with respect to absorption,
distribution, metabolism, and excretion (ADME)
Duration: hours to days
Animals required: 2 species
Safety Pharmacology - CORRECT ANSWER - To investigate any toxicity-use single dose
with 2 species and test cardiovascular, respiratory, CNS effects
Acute Toxicity - CORRECT ANSWER - Determine Maximum Tolerated Dose (MTD) and
No Observable Effect Level (NOAEL)
14 days after single dose in 2 species
Look at mortality, clinical pathology, necropsy, weight change, clinical observations
Sub Acute Toxicity - CORRECT ANSWER - 14-28 days of repeated dosing in 2 species
All of the above parameters and toxicokinetics, immunotoxicity
Subchronic/Chronic Toxicity - CORRECT ANSWER - 30 days to 2 years in 2 species
Carcinogenicity - CORRECT ANSWER - Testing tumorigenic potential in animals
ACTUAL Exam Questions and CORRECT
Answers
Preclinical Development - CORRECT ANSWER - 6-7 years of preclinical testing
Manufacturer completes synthesis and purification of the drug and conducts animal testing
Of 5000 compounds tested, ~5 will appear promising enough for a company to file an
Investigational New Drug Application
If the IND is approved, then the company can begin Phase I clinical trials
Essential Pharmaceutics - CORRECT ANSWER - Structural characterization
Impurity identification
Solubility assessment
Prototype formulation
Stability testing
Screening Efficacy - CORRECT ANSWER - In vitro models
In vivo models
Other
Early ADME - CORRECT ANSWER - In silico profiling
Develop simple analytical method
Measure membrane permeability
Plasma stability
, Early toxicology - CORRECT ANSWER - Off target screen
In vitro cytotoxicity
Preliminary AMES
hERG binding
ADME/PK - CORRECT ANSWER - Test materials with respect to absorption,
distribution, metabolism, and excretion (ADME)
Duration: hours to days
Animals required: 2 species
Safety Pharmacology - CORRECT ANSWER - To investigate any toxicity-use single dose
with 2 species and test cardiovascular, respiratory, CNS effects
Acute Toxicity - CORRECT ANSWER - Determine Maximum Tolerated Dose (MTD) and
No Observable Effect Level (NOAEL)
14 days after single dose in 2 species
Look at mortality, clinical pathology, necropsy, weight change, clinical observations
Sub Acute Toxicity - CORRECT ANSWER - 14-28 days of repeated dosing in 2 species
All of the above parameters and toxicokinetics, immunotoxicity
Subchronic/Chronic Toxicity - CORRECT ANSWER - 30 days to 2 years in 2 species
Carcinogenicity - CORRECT ANSWER - Testing tumorigenic potential in animals
