Term
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Definition
| Investigational New Drug (permission to start human trials) |
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Term
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Definition
| New Drug Application (permission to market) |
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Term
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Definition
| Biological License Application (permission to market) |
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Term
| What are some sources for Drugs? |
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Definition
1) Animals
2) Plants
3) Minerals
4) Humans |
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Term
| Drug Discovery predicted to be significantly accelerated by: |
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Definition
1) Combinatorial Chemistry- rapid synthesis of zillions of compounds
2) High-Throughput Screening- rapid assay of zillions of compounds
3) Biotechnology- Informatics, MABs, new biological entities
4) Pharmacogenomics- rapid identification of targets and patient groups, individualized medicine |
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Term
| Drug Category A for Pregnancy |
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Definition
| Controlled human studies show NO DRUG RISK |
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Term
| Drug Category B or Pregnancy |
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Definition
| Animal studies show no drug risk or animal studies did show risk, but risk not confirmed in human studies |
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Term
| Drug Category C or Pregnancy |
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Definition
| Animal studies- adverse effects, but no human studies OR no animal or human studies available |
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Term
| Drug Category D or Pregnancy |
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Definition
| Positive evidence of human fetal risk, BUT may be acceptable in some clinical situations |
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Term
| Drug Category X or Pregnancy |
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Definition
| fetal abnormalities and/or risks to mother evident AND risks clearly outweigh possible benefits- CONTRADICTED IN PREGNANCY |
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Term
| What did the FDA Modernization Act of 1997 do? |
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Definition
-increase pediatric use info.
-accelerated review of important new drugs
-est. a database on clinical trial info.
- provides guidelines for pharmacy compunding |
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Term
| What are the Missions of the FDA? |
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Definition
1) The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
2) The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. |
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Term
| What happens in the Pre-Clinical Phase? |
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Definition
-HTS and Target Identification
-Cell, Tissue, and Animal Tests
-determine drugs MAO typically
-animal tests for TOXIC effects
-CARCINOGENIC effects
-FETAL ABNORMALITIES |
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Term
| The IND application must include... |
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Definition
1) a description of the overall plan for investigating the drug product and a comprehensive protocol for planned studies
2) a description of the drug substance, including its physical, chemical, and biological characteristics;
3) a description of the general method of preparation of the drug substance;
4) a list of all components, including inactive ingredients;
5) information to assure the proper identification, quality, purity, and strength of the investigational drug; and
6) pharmacological and toxicological studies of the drug, involving laboratory animals to support likely drug safety in clinical trials. |
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Term
| What are the characteristics of Phase I- Clinical Trials? |
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Definition
- fewer than 100 healthy adult human volunteers (typically)
-determine drugs safety and determine its side effects
-provide info on Pharmacokinetics (how body handles drug)
--includes F(bioavailability)
--biotransformation and metabolism in kidney
--half life
--biodistribution
--elimination |
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Term
| What are the characteristics of Phase II- Clinical Trials? |
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Definition
-few hundred pts who have the disorder for which the drug is intended to treat
-determine dos-dependent efficacy
-modes of action
-side effects it causes
-to pass must be SAFE AND EFFECTIVE |
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Term
| What are the characteristics of Phase III- Clinical Trials? |
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Definition
-larger more diverse group of pts 2,000 to 3,000
-confirm clinical value of new drug by comparing to existing drugs
-track effects of drug over time
-provide stats on observed adverse rxns and side effects |
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Term
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Definition
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Term
| Up to several hundred pts |
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Definition
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Term
| Several hundred to several thousand pts |
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Definition
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Term
| Testing mainly for safety |
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Definition
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Term
| Testing for some short-term safety, but mainly for effectiveness |
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Definition
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Term
| Safety, dosage, effectiveness |
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Definition
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Term
| What does the FDA regulate? |
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Definition
1) foods
2) human and vet drugs, biological products, and medical devices
3) cosmetics
4) electronic products that emit radiation
5) advertising on Rx drugs |
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Term
| What the FDA doesn't regulate? |
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Definition
1) advertising on OTC (FTC)
2) Alcohol (Bureau of ATF)
3) Drugs of Abuse (DEA)
4) Water (EPA)
5) Pesticides (USDA, EEPA, and FDA)
6) Consumer Products (Consumer Product Safety Commission) |
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Term
| What is characteristic of Phase IV- Market Experience? |
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Definition
-ensures unexpected drug rxns are detected, reported, and evaluated
-new drug indications
-competetive therapeutic advantage
-problems experienced by people w/ selected conditions
-other quality of life issues |
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Term
| About how many deaths occur in the US from ADEs? |
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Definition
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Term
| When is a Box Warning required? |
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Definition
| when medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects |
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Term
| What is the strongest physician and pt advice that the FDA issues? |
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Definition
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Term
| Where does the FDA require the pharmaceutical company to place the Box Warning and its specific language? |
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Definition
| On the label of the prescription drug and in the literature describing the drug |
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Term
| Who evaluates the Risk vs. Benefits in Drug Therapy? |
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Definition
1) FDA- for the population
2) Provider- for the pt
3) Pt- evaluates in terms of personal values |
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Term
| What are some characteristics of Orphan Drug Products? |
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Definition
-Rare disease or conditions affecting fewer than 200,000 people in the US
-7 yrs exclusivity after approval
-Special financial incentives
-Grants
-Protocol assistance |
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Term
| What is it called when we use drugs already approved for a different indication? |
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Definition
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Term
| What are in the provisions of the Dietary Supplement Health and Education Act of '94 (DSHEA)? |
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Definition
1) define dietary supplements and dietary ingredients
2) est. "new framework" for assuring safety
3) outline "guidelines" for lit. displayed where supplements are sold
4) provide for use of claims and nutritional support statements
5) require ingredients and nutrition labeling
6) grant FDA the authority to est. good manufacturing practice (GMP) regulations |
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