Drug-like Properties Flashcards
What is an orphan drug?
Drug approved for small population that affects 200,000 or fewer Americans
What is a priority review?
RX is given priority review within 6 months instead of the standard 10 months
What is the accelerated approval?
Allows early approval of RX for a serious illness that offers a benefit over current treatment
Based on a a surrogate endpoint (lab measures)
What are the PDUFA Goal Dates?
Deadlines by which FDA must review NDA
What is the Qualified Infectious Disease Program Designation?
RX w/ promise designated as a Qualified Infectious Disease Product by authority of the Generating Antibiotics Incentives Now Act (GAIN Act)
Difference between NME and NCE?
NCE is a RX w/ no active moiety
What is the success rate from RX discovery to launching of a RX product? How long does it take?
5%
About 15 yrs
What does serendipity in drug discovery imply?
Finding one thing while looking for something else
For the lead drug candidate selection process of drug discovery, what is the emphasis on?
Drug-likeness or drugability
During the lead drug candidate selection of drug discovery, how do most drug candidates fail?
Less than optimal physicochemical properties
Lipinski’s Rule of 5 refers to what kind of drug?
Orally active
What is the Lipinski Rule of 5?
MW <500
Log P <5
Donor <5
Acceptor <10
What does the Lipinski’s Rule of 5 tell you?
A compound is more likely to be membrane permeable and easily absorbed by the body if they match the rule
Lipinski’s Rule of 5 is based on what data?
Empirical data
What is the most important descriptor for drug-likeness?
Lipophilicity
If lipophilicity is too high, what can result with that?
Increased % of binding to multiple targets and toxicity, poor metabolic clearance
What is Promiscuity?
Ability to bind to multiple targets
What is the relation between promiscuity and log P?
Postive
In which phase is the NDA released?
After phase 3
In which phase is stats, treatments vs placebo collected?
phase 3
What is required before human testing can start?
IND status
When does full development (decision point) occur during drug development?
Early clinical development
Permission to use a new drug to human is….
IND
Permission to market a new drug is…
NDA
What are the technical aspects of RX development?
- Chemical
2. Pharmaceutical
What are the investigative aspects of RX development?
- Drug Metabolism, PK
2. Safety Assessments
A patent term in the US is how long?
20 yrs
