BSN 315 Pharmacology Exam 1: Drug Development –
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Terms in this set (62)
What are the steps of the drug 1) Drug Discovery
development process in the US? 2) Pre-clinical Phase
3) IND Application
4) Clinical Trials Phase
4a) Phase 1
4b) Phase 2
4c) Phase 3
5) NDA
6) FDA Review
7) Large scale production
To what type of drugs does the full drug True New Molecular Entities: The average new drug in a
development process apply to? brand new family of medicine
How long does the development Approximately 12 years
process of a new molecular entity take?
, How much does it cost to produce a $2 billion
new molecular entity?
What circumstances result in a cheaper 1) Developing a generic drug
drug production process?
2) Developing a drug in a family that already exists
What categories of drugs are 1) Drugs for infectious disease
exceptions to the typical drug
development process? 2) Cancer drugs
Why are drugs so expensive? 1) High cost of development (Both time and money)
2) Short period of exclusive sales (Approximately 8
years before patent expires)
Charge the maximum amount the mountain will allow to
recover losses
PK Pharmacokinetics.
PD Pharmacodynamics
Describe the drug discovery phase of -Step 1
drug development.
-Time: 5 years
-Compounds: 5000
-Objective: Find a compound that modifies the target in
the desired way (Narrow down as some compounds are
structurally similar, but don't have the desired effect on
the target)
Questions & Accurate Answers
Add to calendar
Play your way to mastery with fun games
Match Blocks Charms NEW
Terms in this set (62)
What are the steps of the drug 1) Drug Discovery
development process in the US? 2) Pre-clinical Phase
3) IND Application
4) Clinical Trials Phase
4a) Phase 1
4b) Phase 2
4c) Phase 3
5) NDA
6) FDA Review
7) Large scale production
To what type of drugs does the full drug True New Molecular Entities: The average new drug in a
development process apply to? brand new family of medicine
How long does the development Approximately 12 years
process of a new molecular entity take?
, How much does it cost to produce a $2 billion
new molecular entity?
What circumstances result in a cheaper 1) Developing a generic drug
drug production process?
2) Developing a drug in a family that already exists
What categories of drugs are 1) Drugs for infectious disease
exceptions to the typical drug
development process? 2) Cancer drugs
Why are drugs so expensive? 1) High cost of development (Both time and money)
2) Short period of exclusive sales (Approximately 8
years before patent expires)
Charge the maximum amount the mountain will allow to
recover losses
PK Pharmacokinetics.
PD Pharmacodynamics
Describe the drug discovery phase of -Step 1
drug development.
-Time: 5 years
-Compounds: 5000
-Objective: Find a compound that modifies the target in
the desired way (Narrow down as some compounds are
structurally similar, but don't have the desired effect on
the target)
