Statements (50)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Process
|
| gptkbp:challenge |
High Costs
Long Timelines Patient Recruitment Regulatory Hurdles Scientific Uncertainty |
| gptkbp:cost |
Billions of Dollars
|
| gptkbp:duration |
10-15 Years
|
| gptkbp:fundedBy |
Venture Capital
Pharmaceutical Companies Government Grants |
| gptkbp:goal |
Develop Safe and Effective Drugs
|
| https://www.w3.org/2000/01/rdf-schema#label |
Drug Development
|
| gptkbp:includes |
gptkb:New_Drug_Application
Lead Optimization Marketing Authorization Phase I Trials Phase II Trials Phase III Trials Target Identification Toxicology Studies |
| gptkbp:involves |
Biotechnology Companies
Pharmaceutical Industry |
| gptkbp:monitors |
gptkb:Institutional_Review_Boards
Ethics Committees Regulatory Agencies |
| gptkbp:output |
Approved Drug
Therapeutic Agent |
| gptkbp:regulates |
gptkb:PMDA
gptkb:FDA gptkb:EMA |
| gptkbp:relatedTo |
gptkb:pharmacy
Medicinal Chemistry Pharmacovigilance Translational Medicine |
| gptkbp:requires |
Clinical Research
Intellectual Property Protection Regulatory Compliance |
| gptkbp:riskFactor |
High Failure Rate
|
| gptkbp:step |
gptkb:Discovery
Clinical Trials Regulatory Approval Post-Marketing Surveillance Preclinical Testing |
| gptkbp:uses |
Animal Models
Cell Culture Clinical Data Computational Modeling |
| gptkbp:bfsParent |
gptkb:Sequential_Medical_Trials
|
| gptkbp:bfsLayer |
5
|