Professional Documents
Culture Documents
Sir Colonel Ram Nath Chopra: of Pharmacology
Sir Colonel Ram Nath Chopra: of Pharmacology
DRUG DEVELOPMENT
STAGE – I
CLINICAL STUDIES
NEW PRE CLINICAL Phase 0 – Micro
CHEMICAL STUDIES dosing study
ENTITY (NCE) In vitro : Receptor Phase I – Human
Sources : Organic identification pharmacology and
synthesis : Receptor safety
Animal to
: binding Phase II –
human dose
Molecular : Enzyme Therapeutic
conversation
Modification inhibition INVESTIGATION exploration and dose
: : Secondary NEW DRUG ranging
Isolation from plants messenger analysis Pre- APPLICATION (IND) Phase III –
In vivo : formulation Submission , Therapeutic
Pharmacological study FDA review confirmation and
:
Toxicological study comparison
3 – 10 Years
Phase IV
Post marketing surveillance
Additional indication
Adverse reaction reporting
(Pharmacovigilance)
1 – 2 Years Product defect reporting
2 –4 Years