The document discusses the drug development process, which involves taking a new compound through regulatory approval and marketing. It involves rigorous preclinical and clinical studies to ensure safety and efficacy. The process starts with target identification, lead identification and optimization in preclinical research. It then progresses to three phases of clinical research: Phase I evaluates safety, Phase II assesses efficacy, and Phase III further evaluates efficacy and monitors safety with larger patient groups. The entire development process from early research to marketing approval can take 2-10 years.

1. DRUG DEVELOPMENT
PROCESS
Presented by krishna M 5th pharm d

2. • The entire process of taking a newly
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. The drug
discovery and drug development process is
designed to ensure that only those
pharmaceutical products that are both safe
and effective are brought to market.
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INTRODUCTION

3. THE FOLLOWING
SEQUENCE OF
RESEARCH ACTIVITIES
BEGINS THE PROCESS
THAT RESULTS IN
DISCOVERY OF NEW
MEDICINES
• Target identification
• Target validation
• Lead identification
• Lead optimization
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4. DRUG DEVELOPMENT
PHASES
1. Pre-clinical research
and development
2. Clinical research and
development
3. After the compound is
on the market, a
possible “post
marketing” phase
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5. PRE-CLINICAL PHASE
• The pre-clinical studies represents bench
(in vitro) and then animal test, including
kinetics, toxicity and carcinogenicity. In
the us, an investigational new drug
application is submitted to food and drug
administration seeking permission to
begin the heavily regulated process of
clinical testing in human subjects. IND
phase representing the time from the
beginning of human trails to the new drug
application (NDA) submission that seeks
permission to market the drug is by far
the longest portion of the drug
development cycle and can last from 2
to10 years.
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6. PHASE I
• In this where the human trails
are generally conducted.
• Small group have 10-30 health
volunteer.
• Except for oncology or toxic
compounds.
• Small hospitals with 20-50 beds.
• Last for a day to 2 weeks and
even follow upto a month.
• Safety of the compound study
its pharmacokinetics and
pharmacodynamic.
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7. PHASE II
• Patient upto 300 patients
• Time duration few
months – years
• Efficacy of drug of
particular disease.
• Example – patient with
newly diagnosis but
untreated diabetes no
evidence of end organ
damage used to treat a
new antidiabetic agents.
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