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Pharm-Drug Approval
Drug Approval
| Question | Answer |
|---|---|
| what authority does the FDA have over drug development and use (4) | 1) requires demonstration of drug efficacy; 2) demonstration of safety; 3) regulate drug testing and manufacture; 4) force withdrawal |
| the FDA has oversight of drug development and usage, with what exceptions (3) | 1) does not regulate non-prescription drug advertising; 2) prescription drug advertising reviewed, but not pre-approved; 3) DEA regulates controlled substances |
| what is the first form to submit for drug approval | IND (investigational new drug) |
| what is required before IND is submitted | chemistry / animal testing |
| what cannot happen before IND is submitted | human testing |
| what is the next form that needs to be submitted | NDA (new drug application) |
| what is needed to support the NDA | clinical studies |
| how many phases of clinical studies are there | three |
| what part of drug approval requires the most time and resources | clinical trials |
| how much can it cost for developing a new molecular entity | one hundred million dollars and more |
| what is a new IND required for (2) with the same drug | 1) each dosage form; 2) each disease target |
| what is the IND approval process like | they are not approved, but are put on a "clinical hold" by the FDA within 30 days - if there is no hold placed, the sponsor may proceed |
| what must the sponsor continually send the FDA, as far as the IND (3 - forms/reports, not general information) | 1) annual IND reports; 2) IND amendments that describe change in trials; 3) safety reports |
| what are three pieces of general information that must be included in the IND application | 1) description of drug (chemical analysis, stability); 2) description of drug product (e.g. tablet); 3) proposed drug labeling to guide IND clinical investigators |
| what is some pharmacologic/toxicology information expected to be included in the IND (3) | 1) MOA/effects in animals; 2) absorption/metabolism/distribution/elimination (pharmacokinetics) studies in vitro and in animals; 3) toxicology |
| what types of toxicology studies are done (2) | 1) acute; 2) chronic |
| what information is necessary for a NDA application (3) | 1) information from IND; 2) new data from animal studies; 3) clinical data from phase 1-3 trials |
| what things are looked at in phase 1 studies (3) | 1) metabolism; 2) drug/food interactions; 3) adverse effects |
| what things are looked at in phase 2 studies (3) | 1) dose-ranging; 2) detailed pharmacokinetics; 3) first efficacy data |
| what things are looked at in phase 3 studies (2) | definitive safety/efficacy studies |
| what % of drugs successfully get through phase 1, 2, and 3 | 70%, 33%, 25-30% |
| when must NDA reports be submitted once a drug is approved, and for how long | every year, as long as the drug is marketed |
| what is post-marketing reporting (NDA annual reports) focused on | drug safety |
| what were two "problem areas" of adverse effects that have led to drug withdrawal | 1) hepatic toxicity; 2) promotion of ventricular arrhythmias |
| how effective is adding "black box" warnings to problem drugs | FDA considers it to be ineffective |
| what are "risk management action plans" | when the FDA approves limited access to high-risk drugs if medically necessary |
| what example was given | thalidomide for leprosy, despite risk of phocomelia |
| what conditions are placed on thalidomide prescription (3) | 1) restricted set of prescribers; 2) patient registry; 3) agree to use two types of birth control |
| what does ANDA stand for | abbreviated new drug application |
| what is ANDA meant for | generic versions of previously approved drugs |
| what is not necessary in an ANDA | repetition of clinical safety/efficacy studies |
| what must the company show in the ANDA application | that drug is identical (chemical analysis, formulation process, pharmacokinetics) |
| what is the purpose of the orphan drug act (what three things are provided, and for what purpose) | provides: 1) research grants; 2) tax credits; 3) and extended exclusive marketing for drugs that treat rare diseases |
| what are examples of drugs (and their uses) that are covered in the orphan drug act (2) | 1) digoxin immune Fab (for digoxin toxicity); 2) imatinib (Gleevac) for CML |
| what constitutes a "rare disease" | <200,000 patients/year |
| what are "treatment INDs" and who do they apply to | allows patients not in clinical trials to use drugs at phase 3 stage - only applies for seroius conditions for which there is no approved alternative treatment |
| what drugs are eligible for accelerated development | those meant for life-threatening and severly debilitating illnesses; drugs may have to address unmet clinical needs |
Created by:
mcafej02
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