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Clinical
Studies in humans
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Drug Development pipeline
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Drug Discovery- Preform/biological characterization/initial formulation-IND- Final product/Clinical trials/ Long term toxicity---- NDA
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Hit
Molecule that interacts with targets
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Lead
The best hits that warrant further investigation
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Candidate
The lead most suitable for extensive investiagion
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Biological characterization
Potential for use as therapeutic agent by- pharmacology, toxicology, disposition and pharmacokinetics.
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Preforumulation broken into (2)
- Physicochemical properties
- Analytic method developement
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Physicochemical properties
pKa, Solubility, Stability
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Dosage formulation
Process of turning an active compound into a form and strength suitable for human use.
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Investiagional New Drug Application (IND)
Must be filed with FDA before human testing
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Main purpose of IND
- 1) Protect rights and safety of the human subjects.
- 2) Ensure investigational plan is sound
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Phase 1 clinical drug trials
- Mainly safety, 20-100 (usually healthy) patients.
- 67% pass through takes several months
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Phase 2
- Patients suffering indication
- several hundred
- up to two years
- 45% pass
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Phase 3
- Thousands
- 1-4 years
- 5-10% pass
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NDA Application
Integrates all data
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cGMP
Apply to all aspects of pharmaceutical manufacture... all manufacturing facilities are inspected.
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Complete response letter
Application not ready for approval
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Phase 4 clinical studies
Add to the understanding of the drug's effects.
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Adverse reaction reporting
Required by everyone, physicians, postmarketing studies, and pharmacists
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IND for rare orphan drugs
Financial support for clinical trials of these drugs, seven years of exclusive marketing rights.
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Treatment protocol
Filed during phase 1 or 2 to allow treatment of the desperately ill.
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Bioavailability
NDA used for generic drug approval.
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Supplemental new drug applicagtion
required for changes of method of synthesis, formulation, analytical standards, container or manufacturing facilities.
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Costs of clinical trials
Most expensive is NDA submission, least expensive is pre clinical.
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