Discovery and Preclinical

Development
NEW DRUG DEVELOPMENT
THE PROCESS OF DRUG DEVELOPMENT
The average time for a drug to reach
the market 8-15 years
Cost 800 million dollars
-Process
Drug discovery
Drug development
Steps in drug discovery
Target identification
Target validation

Identify the potential targetbiological target specific to the

disease.
Target identification
Genomics
STRUCTURAL describing the
Arrangement of the genome
Functional Assesses the function of
a particular gene
Proteomics
Understands the structure of the
proteins and any influence on the
post translational modifications in
the proteins
Understand the effect of the
molecules on the proteins involved in
the disease

Lead identification

Target identification

Lead optimization

Bioinformatics

Preclinical development

Storage,analysis,treatment,organisat
ion and comparison of observations
from different fields of medicine like
physiology,biochemistry,etc.

Clinical development
Steps in drug development
Preclinical pharmacology

Target verification/Selection

Preclinical toxicology

Use the available ligands

Pharmacokinetics ADME

Use of genetic models

Formulation and development

E.g.Knock in or knock off mouse

CLINICAL TRIALS

Confirm the role in the particular

pathological condition

Target identification
Rational drug discovery

Lead Identification
Synthesis of new compounds that can

Block the activity of a ligand

Inhibit the activity of the target

5000 compounds- hits

Prevent the expression of the

target

5 drug candidates enter the clinical

phase

Bring about alterations in the

target cell
after the
combination

Preclinical studies
Invivo assays

Pharmacodynamics

Screening

Pharmacodynamics

1.Development of a screening methods

Drug interactions

2.High throughput screening

Molecules --------

In-vitro-assays for mechanism of

drug action

Lead Identification

-Hits---------------Lead

screened
(In-vitro)

screened
(in-vitro and in

vivo)

Toxicology studies

Formulation and development

Formulation

Lead Optimisation

Dosage forms

Potency in the disease-In vivo assays

Stability studies

Pharmacokinetics

Clinical studies

Early toxicology

Phase-I

Lead candidate-----OPTIMISATION---Drug candidate,

Phase-II

The funnel of drug development

>10,000 compounds synthesised

Phase-III
Phase-IV