Drug Discovery and Development (15.04.24).pptx

Drug disvovery and development

1. Drug discovery and development process Department of pharmacology ASMC, Firozabad

2. Drug Research Target selection Lead discovery Medicinal chemistry Behavioural studies Ex- vivo studies Toxicology Studies 3 to 6 years Preclinical Drug Development 5,000- 10,000 compounds 250 In vitro studies Animal models & disease In vivo studies

3. Target selection Cellular & genetic targets Genomics Proteonomics Bioinformatics Lead discovery Synthesis & isolation Combinatorial chemistry Assay development High throughput screening Medicinal chemistry Drug Library creation Structure activity studies In silico screening Chemical synthesis In vitro studies In vivo studies Drug affinity & selectivity Cellular disease models Mechanism of action Lead candidate refinement Animal models & disease states Behavioural studies Ex- vivo studies Toxicology Studies 3 to 6 years Preclinical Drug Development 5,000- 10,000 compounds 250

4. Clinical trials Clinical Drug Development Phase IV Post marketing surveillance Indefinite 0.5 to 2 years 6 to 7 years 20-100 Phase I Phase II Phase III 500-5000 100-500 Number of volunteers FDA Approval 5 compounds 1-2 drugs

5. Phases of clinical trial Phase I (1 st in human) Phase II (1 st in Patient ) Phase III (Multi-c entric Trial) Phase IV (Post Marketing Surveillance) I N D Subjects Usually healthy volunteers Patient r eceiving experimental drugs) Patients receiving experimental drugs) N D A Patients in treatment with approved drugs) Number 10-100 100-500 500-5000 > 1000s Measures Safety and tolerability ( IIa ) Dose ranging & ( IIb ) Efficacy Confirm efficacy in larger population Adverse events, compliance, drug-drug interactions Type of Study Open label Uncontrolled/ Controlled t rial Randomized controlled/ comparative trial Open label Time Several months 1-2 yrs 3-5 yrs No fixed duration Cost US $10 million US $ 20 million US $ 50-100 million -

6. The Pipeline