HNG 540 Exam 3 #1 Questions with correct answers
Steps in drug development life cycle - ✔✔1. Discovery
2. Preclinical
3. IND
4. Clinical trials
5. NDA
6. Post marketing surveillance
What does the FDA do with respect to drug development? - ✔✔Regulates
pharmaceutical market
Ensures safety and efficacy
Enforces food, drug, and cosmetic act
What is lead optimization? - ✔✔Chemically-related series that survive initial
screening and then optimized to improve their safety and efficacy
Use SAR's
Preclinical stage involves how many animal species? - ✔✔2
What is therapeutic index? - ✔✔(Drug concentration associated with
toxicity)/(Drug concentration associated with efficacy)
The higher this ratio, the safer the medication
,What does the IND application contain? (3) - ✔✔Acute toxicity of drug substance
in at least two species of animal
Short-term toxicity studies
Pharmacological profile of drug
Phase 1 clinical trials characteristics - ✔✔First-in-human dosing to healthy
volunteers
Administration of single escalating doses of drug to small number of subjects
Short term multiple doses
10-15 volunteers
Assess safety and PK
Phase 2 clinical trials characteristics - ✔✔First dosing to patients
First evaluation of efficacy
Safety profile and PK monitored
Assess proof of concept
20-100 subjects studied
Phase 3 clinical trials characteristics (4) - ✔✔Test effectiveness of drug
Common effects documented in larger population
Finalize prescribing label
>1000 subjects
Phase 4 clinical trials characteristics - ✔✔Post-marketing approval studies
Additional information about safety and efficacy
, 300-3000 volunteers
What does an NDA contain? (5) (LSCLM) - ✔✔1. Labeling of product
2. Safety and efficacy results
3. Clinical trial results
4. Long-term studies and post-marketing surveillance
5. Method of drug manufacture and quality control analysis
Who reviews the NDA and how long does it take? - ✔✔FDA and 6-18 months
NDA review requirements for brand name drugs? - ✔✔Chemistry
Manufacturing
Controls
Labeling
Testing
Animal studies
Clinical studies
Bioavailability
ANDA review requirements for generics? (CMCLTB) - ✔✔Chemistry
Manufacturing
Controls
Labeling
Testing
Steps in drug development life cycle - ✔✔1. Discovery
2. Preclinical
3. IND
4. Clinical trials
5. NDA
6. Post marketing surveillance
What does the FDA do with respect to drug development? - ✔✔Regulates
pharmaceutical market
Ensures safety and efficacy
Enforces food, drug, and cosmetic act
What is lead optimization? - ✔✔Chemically-related series that survive initial
screening and then optimized to improve their safety and efficacy
Use SAR's
Preclinical stage involves how many animal species? - ✔✔2
What is therapeutic index? - ✔✔(Drug concentration associated with
toxicity)/(Drug concentration associated with efficacy)
The higher this ratio, the safer the medication
,What does the IND application contain? (3) - ✔✔Acute toxicity of drug substance
in at least two species of animal
Short-term toxicity studies
Pharmacological profile of drug
Phase 1 clinical trials characteristics - ✔✔First-in-human dosing to healthy
volunteers
Administration of single escalating doses of drug to small number of subjects
Short term multiple doses
10-15 volunteers
Assess safety and PK
Phase 2 clinical trials characteristics - ✔✔First dosing to patients
First evaluation of efficacy
Safety profile and PK monitored
Assess proof of concept
20-100 subjects studied
Phase 3 clinical trials characteristics (4) - ✔✔Test effectiveness of drug
Common effects documented in larger population
Finalize prescribing label
>1000 subjects
Phase 4 clinical trials characteristics - ✔✔Post-marketing approval studies
Additional information about safety and efficacy
, 300-3000 volunteers
What does an NDA contain? (5) (LSCLM) - ✔✔1. Labeling of product
2. Safety and efficacy results
3. Clinical trial results
4. Long-term studies and post-marketing surveillance
5. Method of drug manufacture and quality control analysis
Who reviews the NDA and how long does it take? - ✔✔FDA and 6-18 months
NDA review requirements for brand name drugs? - ✔✔Chemistry
Manufacturing
Controls
Labeling
Testing
Animal studies
Clinical studies
Bioavailability
ANDA review requirements for generics? (CMCLTB) - ✔✔Chemistry
Manufacturing
Controls
Labeling
Testing
