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

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