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29 Cards in this Set
- Front
- Back
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FDA |
Food and drug administration |
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PK |
Pharmacokinetics Drug concentration Time it stays in the body at a certain dose conc. |
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PD |
Pharmacodynamics Observed effects from a given dose concentration |
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IACUC |
Institutional Animal Care and Use Committee 3+ members Scientist Veterinarian (AVMA is vets governing body) n Non affiliated Inspect Every 6 months Gives all protocol approvals |
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CRO |
Contract Research Organization |
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AAALAC |
Association for Assessment and Accreditation of Laboratory Animal Care It is voluntary |
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NIH |
National Institutes of health |
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OLAW |
Office of Laboratory Animal welfare |
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3 R's |
Replacement Reduction Refinements Regarding laboratory Animal use |
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GLP |
Good Laboratory Practice 5 basic points Resources Rules Characterization Documentation Quality Assurance |
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AVMA |
American Veterinary Medical Association Set animal health and Euthanasia Standards |
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IBT |
Industrial Bio Test Laboratories |
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NDA |
New Drug Application |
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IND |
Investigational New Drug |
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ANDA |
ABBREVIATED New Drug Application |
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FIFRA |
Federal Insecticide,Fungicide and Rodenticide Act From the EPA |
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TSCA |
Toxic Substance Control Act EPA's |
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OECD |
Organization for Economic Co-operation and Development 1986 34 Countries All EU countries US JAPAN HELPS with the reduction b/c of shared data |
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SOP |
Standard Operating Procedure |
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IRB |
Institutional Review Board |
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GCP |
Good Clinical Practice |
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SAD |
Single Ascending Dose |
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MAD |
Multiple Ascending Dose |
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CMC |
Chemistry Manfacture (info) control Must be included in the IND application |
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RLD |
Reference Listed Drug |
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LD50 |
Lethal dose to kill 50% of population |
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ED50 |
Effective Dose to cure 50% of population |
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ICH |
International Conference on Harmonization Benefits>risks Data supports trial Clear protocol Informed Consent GMP |
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MTD |
Maximum Tolerated Dose Pre Calculated Safe levels of dose Or the dose at which intolerable side effects show up
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