Introduction on Drug Research and Development(R D) Process in the USa
Introduction on Drug Research and Development (R & D) Process in the USA 1
“Rock” Diagram of Drug Development Process Targets Toxicology IND Screens|→ Selection IⅢ NDA Pharmaco kinetics SAR 2,000 cpds 20 year 50 Mill 50 100200400 800 Discovery Pre-clinical Clinical Marketing 2
“Rock” Diagram of Drug Development Process Targets Scrrens SAR Discovery Pre-clinical Clinical Marketing I II III Toxicology Pharmacokinetics Selection NDA IND 2,000 cpds 20 6 3 2 1 1 year 1 1 2 3 50 Mill 50 100 200 400 800 2
Drug Development Process 11. Discovery stage (2). Pre-clinical Stage (3). Clinical Stage (4). Marketing Stage 3
Drug Development Process (1). Discovery Stage (2). Pre-clinical Stage (3). Clinical Stage (4). Marketing Stage 3
Major steps in Discovery stage Target generation and selection Development Method set-up Method validation Technique assesment assay development and validation Automation Optimization Compound library High throughput screens ∫ Combinatorial chemistry Library chemistry Natural products Lead confirmation and chemistry Preliminary pK investigation SAR In vivo functional tests
Major Steps in Discovery Stage Target generation and selection Compound Library Combinatorial chemistry Library chemistry Natural products { Development Method set-up Method validation Technique assesment Automation Optimization } High throughput screens Lead confirmation and chemistry In vivo functional tests Assay development and validation Preliminary PK investigation SAR 4
Target Generation and Selection Target Target Target as Target based on associated mechanism causing hypothesis with disease of disease disease Schizophrenia Alzheimer P arkinson Genetics (DA in Pfc (Aβ-42) DA in Striatum) (Disease genes) Copying others (Fluoxetine and Screening arket analysis olanzapine stories)
Target Generation and Selection Screening Target based on hypothesis Target associated with disease Target as mechanism of disease Target causing disease Copying others (Fluoxetine and olanzapine stories) Schizophrenia Alzheimer Parkinson Genetics (DA in Pfc) (Ab-42) (DA in Striatum) (Disease genes) Market Analysis 5