PGx and Drug Development Flashcards
Preclinical or Phase 0
Preparation for human studies
Data collection and exploratory studies
Key componets of Clinical Pharmcology
Optimal use of existing medicines
Evaluation of new drugs
Most drugs kill in what phase?
2
Pharmacists + Discovery Phase (Consulation)
Selection of lead compounds Assist in preclinical pharm/toxicity SAR study consult Help in GO decisions Assist in formulations Participate in quality evaluation and Pre-IND meeting
Pharmacists + Development phase (MAJOR role)
Clinical PK/PD studies Population PK Dose response PGx Post-marketing
Preclinical pharmacology leads to ? Clinical?
Case report
Individual responses
Type of clinical trials
Treatment Prevention Screening and early detection Diagnostic Genetics QofL
Goals
ID safe starting dose with possible activity
Determine end-organ toxicities and reversibility
Guide dosing regimens and escalation schemes
Define randomization
Two groups: Control and investigational
Define Stratification
4 groups: Grouped by genomic characteristics and then split into control and investigational
What do we want in trials?
If drugs are going to fail, we want them to fail early, fast and often
Microdose studies are used
PK or imaging study endpoints
Pharmacological relevant doses
Higher than microdose
More safety data needed
PD endpoints!!!
Pharmacodynamic endpoint studies
Higher than microdose
More safety data needed
Biomarker endpoints!!!
What do you have to have in order to do Phase 0? How long is phase 0?
a biomarker!!!
<7 days
How many patients in phase 0?
2-7 patients
