DRUG DEVELOPMENT PATHWAY Phase 1 Phase 2
Animal pharmacology
Disease characterisation
Proof of concept on animal model
Safety pharmacology
Toxicology studies Animal pharmacokinetic
‐ ‐ ‐
single dose repeated dose etc
Preclinical production manufacturing and analytical development
Orphan Drug Designation EMEA
Pre IND meeting
IND submitted
Phase 3
Human pharmacology Phase I
Human pharmacokinetic Phase I
GMP production
Clinical trial
Clinical trial
Phase II
Phase III
(* MRC Clinical trials tool kit)
(* MRC Clinical trials tool kit)
Marketing Autorisation (EMEA / FDA)
GMP production final formulation
Clinical Trial Authorisation National Agencies
30 day IND safety review
End of Phase 2 meeting
NDA Submitted
NDA Approved
Range 1‐3 years (Average 18 months)
Range 2‐10 years (Average 5 years)
6‐10 months
Exploratory Research
Clinical Development
NDA review
Preclinical Development
