INDustry
Overview
INVESTIGATIONS
DRUGs
biologics
DEVICEs
VACCINE
PLATFORMS
RAVE
DSG
TRIAL MASTER
MEDRIO
Inform
ORACLE RDC
inductive
POPULATIONS
Healthy Volunteers
ONCOLOGY PATIENTS
OTHER PATIENTS
SPECIAL POPULATION
INDICATIONS
ONCOLOGY
INFECTIOUS DISEASES
OPHTHALMOLOGY
RESPIRATORY
IMMUNOLOGY
GASTROINTESTINAL
NEUROSCIENCE
rare diseases
methodology
FREQUENTIST
BAYESIAN
decision theoretic
STUDY TYPES
SINGLE DOSE ESCALATION
MULTIPLE DOSE
ESCALATION
BIOEQUIVALENCE
PROOF-OF-CONCEPT
DOSE FINDING
FOOD EFFECT
ETHNIC BRIDGING
DRUG drug INTERACTION
THOROUGH QT
confirmatory efficacy
STUDY designs
ASCENDING DOSE
ALTER NATING PANEL
3+3, continuous reassessment
PARALLEL group
CROSS-OVER
INCOMPLETE BLOCK
sequential, ADAPTIVE
PHASES
0 -Experimental studies
1a, 1b – dose-escalation, safety
2a, 2b – dose-ranging, poc
3 – confirmatory
4 – post-marketing, registrY
REGULATORY AGENCIES
FDA
EMA
PMDA
NMPA
REST OF THE WORLD