1. The document discusses drug discovery and development, outlining the need to address unmet medical needs like new diseases as well as the costs of existing therapies. 2. It describes the historical aspects of clinical trials and regulations dating back to the 1500s, and outlines the modern drug development process including discovery, preclinical studies, and clinical trials through the various phases. 3. The drug development pathway involves discovery, preclinical development including chemistry/pharmacology and toxicology studies on animals, and clinical development including Phase I-III trials on volunteers and patients, with the goal of regulatory approval and market introduction over approximately 10-15 years.

1. DRUG DISCOVERY
Dr.Gurumeet C Wadhawa ,Assistant Professor, Department of Chemistry.
Rayat Shikshan sansthas Veer Wajekar ASC College,Phunde,Uran

2. Drug…
Any chemical that produces a change in the
body…
Defined by characteristics:
1. Use or potential use in diagnosis or treatment
of disease
2. Selective in their actions

3. Need for Drug Discovery
Unmet Medical Needs:
New Diseases ,AIDS, Alzheimer’s, obesity
Low efficacy – dementia, cancer
Side effects – antipsychotics, antidepressants
Downstream health cost - (Alzheimer’s; spinal
injury)
cost of therapy; (Interleukins)
costs to individual/country; (depression)
Sustain industrial activity; pharmaceutical
industry employs thousands and makes a massive
contribution to overseas earnings; patent expiry

4. The changed context of drug
discovery and development
HISTORICALASPECTS
1537-first clinical trial of a novel therapy by
Amboise pare
1747-James Lind introduced control groups in
experiment, document citrus fruits in the diet
prevent scurvy
1863- Placebos were first used
1923-concept of randomisation introduced
1931-concept of randomisation of patients to
treatment in clinical trials
1945-ethical impact of clinical trial has become

5. 1947-thse regulations enshrined in Nuremberg
codex
1948-1st trial using properly randomised treatment
and control groupss by medical research counsil
1964- introduction of declaration of Helsinki
Amended in 1975, 1983, 1989, 1996, 2000, 2002
and 2004

6. Drug development
Drug development-The entire process of taking a
newly discovered compound or drug through
regulatory approval to the point of marketing.
During the development, the new drug or the
compound should adhere to high standards in the
conduct, analysis and interpretation of
preclinical and clinical studies for its smooth
passage through the regulatory approval phase
and eventually to marketing.
Pathways of drug development are
Discovery
Preclinical development
Clinical development

10. PROCESS
Discovery
Preclinical studies
CHEMISTRY/
PHARMA-
COLOGY
IND* PHASE IV
Search for
active
substances
Toxicology,
efficacy studies
on various
types of
animals
Regulatory
review
Clinical studies
on a limited
scale
Comparative
studies on a
large number
of patients
Regulatory
review
Continued
comparative
studies
*Investigational
New Drug
Application for
permission to
administer a new drug
to humans
Efficacy
studies on
healthy
volunteers
50–150
persons
100–200
patients
500–5,000
patients
Registration,
market
introduction
**New Drug Application
Application for permission
to market
a new drug
KNOWLEDGE
LEVEL
KNOWLEDGE
LEVEL
2–6 MONTHS 3–6 YEARS 1–3 YEARS
Approximately 10–15 years from idea to marketable drug
TIME SPAN
2–4YEARS
Clinical studies
Early Clinical Development
PHASE I PHASE II PHASE III NDA**

11. T
H
A
N
KY
O
U