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