Term
| What are the reasons for interest in animal health? |
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Definition
1. Economics
2. Research
3. Zoonosis
4. Lots of companion animals
5. Lots of food-producing animals |
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Term
| What formulation considerations are commonly used for feed additives? |
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Definition
1. Drug concentration
2. Moisture content of the drug and carrier
3. Electrostatic charges
4. pH extremes
5. Flow |
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Term
| What are the advantages of dosing animals through drinking water? |
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Definition
1. Sick animals still drink
2. Animals drink 2x more than they eat |
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Term
| Definition of preparation. |
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Definition
| final compounded medication |
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Term
| Definition of compounding. |
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Definition
| Customized preparations not otherwise commercially available |
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Term
| Definition of manufacturing |
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Definition
| Distribution of inordinate amounts of compounded preparations |
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Term
| Basis of FDA consent decree for KV pharmaceuticals |
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Definition
| 2x Morphin tablets; prevents KV from making and distributing adultered and unapproved drugs; prevents manufacturing and shipping until FDA approval is obtained |
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Term
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Definition
| radiation, cosmetic, medications, blood, animal drug, and medical device products |
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Term
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Definition
| text of all US government regulations, including FDA regulations |
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Term
| Acts of congress related to the FDA |
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Definition
1. 1906 act - misbranding & adulteration
2. 1927 act - extended coverage to cosmetics, authorized factory inspectiosn
3. 1938 act (sulfanomide elixir) - required drugs to be safe, required preclearance
4.1962 Kefauver-Harris amendment - passed because of Thalidomide disaster; strengthened safety requirements; drugs have to be proven efficacy; increased requirement for new drug information
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Term
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Definition
1. Center for Drug Evaluation and Research (CDER)
2. Center for Biologics and Research (CBER)
3. Center for Devices and Radiological Health (CDRH) |
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Term
| Who is tested in Phase I Clinical Trials? |
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Definition
-Healthy human volunteers - "frisby players"
-20-80 volunteers |
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Term
| Who is tested in Phase II Clinical Trials? |
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Definition
-A few patients affected with the disease the drug is aiming to treat
-200-300 subjects |
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Term
| Who is tested in Phase III Clinical Trials? |
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Definition
-Large number of patients affected with the disease the drug is aiming to treat
-1000-3000 |
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Term
| What are the missions of early development? |
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Definition
1. Reduce time to market
2. Know what you have
3. Be able to ensure equivalence/sameness with later manufactured drug substance (API) and drug product |
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Term
| What are ways to learn about new drugs under development? |
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Definition
1. Learn by doing - transfer to plant early and learn while scaling up
2. Learn before doing - develop a knowledge base using laboratory scale experiments, computer aided simulation, theory , and algorithms
3. Learn after doing - A prescription for recalls and regulatory problems |
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Term
| What are common reasons for recall? |
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Definition
1. Packaging & Labeling
2. Temperature abuse
3. Microbial contamination of sterile products |
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Term
| Animal species commonly used in preclinical studies |
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Definition
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Term
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Definition
1. Complete list of components of the drug
2. Best available descriptive name of the drug and how it is to be administered
3. Quantitative composition of the drug |
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Term
| Amount of impurities allowed in a drug |
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Definition
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Term
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Definition
-determine if drug is safe for humans
-determine if protocol will expose subjects to unnecessary risk |
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Term
| Elements of preformulation |
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Definition
--particle size
--Mp
--IR, DSC, XRPD
--Purity |
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Term
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Definition
*list of investigators/their credibility
*list of components of drug
*evaluation of safety & effectiveness |
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Term
| Differences between an NDA and an ANDA |
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Definition
*ANDA = (called abbreviated) because does not require: preclinical & clinical data (instead generic applicants must scientifically demonstrate bioequivalence)
*24-36 healthy human volunteers |
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Term
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Definition
claim of intellectual property
document that says you own: a molecule, solid form, or method |
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Term
| Requirements to receive a patent |
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Definition
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Term
| unexpected results of plavix |
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Definition
| *only the dextro-rotatory enantiomer Id exhibits a platelet aggregation inhibiting activity, the levo-rotatory enantiomer I1 being inactive. Moreover, the inactive levo-rotatory enantiomer I1 is the less well tolerated of the two enantiomers |
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Term
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Definition
| claim to ownership or molecule |
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