Dr.

Keerthi Sagar J

Methods of Drug Development

Random Screening Serendipity Blind hitting procedure Studies on animal

Molecular modification
Rational drug designing Designing of a Prodrug

behavior etc. Eg: Morphine, Atropine, Digitalis, Penicillin Limitations: Cumbersome , Time consuming, Expensive, Might not have fruitful results

Methods of Drug Development

Random Screening Serendipity Happy observation by

Molecular modification
Rational drug designing Designing of a Prodrug

chance New use of old drug Side effects find a new therapeutic use Eg: Lignocaine, Phenytoin, Methotrexate, Cyclophosphamide, Minodoxil

Methods of Drug Development

Random Screening Serendipity Synthesis of chemical

Molecular modification
Rational drug designing Designing of a Prodrug

analogues of drugs Advantage in pharmacokinetic parameters Decrease toxicity Eg: Thaizides Limitations: Me too Drugs

Methods of Drug Development

Random Screening Serendipity Understanding

Molecular modification
Rational drug designing Designing of a Prodrug

biological activity and chemical structure Eg: ACE inhibitors, H2 Antagonists

Methods of Drug Development

Random Screening Serendipity Eg: Levodopa,

Molecular modification
Rational drug designing Designing of a Prodrug

Paracetamol, N- acetyl Procainamide

From Hits To Leads

Sochlet Apparatus

Analysis of Active Ingredient

Gas Chromatography
UV Spectrophotometer HPLC

HPTLC
NMR Spectrophotometer X- Ray Crystallography

Invitro methods
Bioassay
Direct end point assay Quantal assay

Graded assay
a. b.

c.
d.

Bracketing assay Matching assay Interpolation assay Multiple point assay

In vivo studies
Animal studies for behavior Eddys Hot Plate Elevated plus maze Rota rod apparatus Electroconvulsiometer

Toxicity studies
Acute toxicity
Subacute toxicity Chronic toxicity

Special toxicity Male fertility studies Female fertility studies Teratogenicity Carcinogenicity

Clinical trials
Schedule Y Drugs & Cosmetics Rules 2005 [Ministry

of Health & Family Welfare] Definition : A systematic study of a new drug in human subjects to generate data for discovering and verifying the clinical, pharmacological & adverse effects with the objective of determining safety and efficacy of new drugs

Need for clinical trials

Evaluation of new drugs for its efficacy & safety
To know benefits and risks

Types of Clinical trials

Therapeutic trials Analgesics, anticonvulsants Prevention trials Vitamins, Vaccines Diagnostic trials Finding better test Screening trials MRI, PET Scan Quality of life trials Side effects reducing drugs

Requirements for Clinical Trials

Preclinical study data
Clearance from IRB/ IEC Informed Consent

Approval from Regulatory authorities like FDA, IND

Informed consent
Oral consent
Written consent

Institutional Ethics Committee