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26 Cards in this Set

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purpose of preclinical testing
1) obtain lethal dose in 10% animals
2) define qualitative and quantitative organ-specific toxicity
3) define initial safe dose for phase I study
Phase 0 study conducted under what application?
exploratory IND
Phase 0 dosing
use microdose => 1/100th of dose calculated to yield a pharmacological effect
when is NDA filed?
prior to beginning clinical trials. Waiting period of 30 days after application submitted before start
contents of NDA
drug chemistry, preclinical data, proposed clinical protocols, investigators brochure, manufacturing info, pharmacology/toxicology information
studies exempt from IND
1) no new indication or significant label change
2) no significant change in advertising
3) no significant increase in risk due to change in route, dose level, or special use population
4) when conducted in compliance with IRB and informed consent guidelines
FDA 1572 form?
brief CV of investigators & IRB information
objective of phase I studies?
1) determine pharmacology, pharmacokinetics, pharmacodynamics
2) determine MTD and rec phase II dose
3) describe toxicities and DLT
starting dose for phase I trials
1/10 LD10

LD10= dose that kills 1/10 mice tested
objective of phase II studies?
collect data on safety and efficacy. May or may not evaluate PK
objective of phase III studies
compare new agent to current std of care and assess efficacy and safety using desired marketed dose form
purpose of NDA
A formal submission to the FDA after all studies have been completed that presents preclinical and clinical data to obtain marketing approval
purpose of ANDA
approval of generic- bioequivalency results must be within 20%-30% of innovator
purpose of phase IV study
collect long term data after drug marketed
an Expedited review...
approval based on phase II. Further study may be required
an Accelerated approval...
Conditional approval based on benefit over existing therapy - approved on a surrogate end point after phase III
Fast track
accelerated IND stage- drugs filling unmet need
What is the Lymphatic System? What does it do?
-separate circulatory system
-transports interstitial fluid (T-cells to blood circulatory system)
What is a Priority Review?
NDA that is reviewed in 6 months rather than 1 year - all oncology drugs fit this category
What does it mean to obtain study drugs under a SPECIAL EXCEPTION?
Same as a compassionate use IND, except investigator uses CTEP IND instead of FDA IND. The drug comes from CTEP and is usually in phase II-III testing.
What does it mean to obtain study drugs under a GROUP C (EXPANDED ACCESS)?
Agent is in the regulatory pathway (Phase III completed) and likely to be approved.
What does it mean to obtain study drugs under a TREATMENT REFERRAL CENTER mechanism?
Available to comprehensive cancer centers with an NCI designated protocol in high priority diseases.
Definition of a complete response?
disappearance of all target lesions
Definition of a partial response?
At least a 30% decrease in the sum of the longest diameter of target lesions
Definition of progressive disease?
At least a 20% increase in the sum of the longest diameter of target lesions
Definition of stable disease?
Neither sufficient shrinkage nor increase to quailify for PR or PD