BTEC 3317 Final Exam 2022/2023 with complete solutions.

Based on FDA's definition of a drug, what is a drug not supposed to do to a patient's disease or condition? Treat Prevent Exacerbate Diagnose Mitigate Exacerbate What is not a good reason as to why there may remain a market for a new drug even if there is already an approved drug for a particular indication? The new drug for headache is a combination tablet that contains two different APIs while currently, two tablets have to be taken separately to get headache relief The currently marketed drug is very expensive The currently marketed drug is injectable while the new drug will be oral An anti-depression drug that produces suicidal thoughts will be preferred over an already marketed one that doesn't For any given drug, more than 50% of patients with a condition may not respond to the existing drug An anti-depression drug that produces suicidal thoughts will be preferred over an already marketed one that doesn't 00:07 01:38 FDA defines a drug as any substance used for diagnosis, control, mitigation, prevention or treatment of disease. What would be an example of a combination drug product? Pregnancy test kit Dental floss Tongue depressor Baby aspirin Lab microwave Pregnancy test kit Orphan drugs are pharmaceutical and biological products that target diseases affecting under 200,000 patients in the US. What is not an incentive given to manufacturers to encourage the development of orphan drugs? Clinical trial requirement is waived PDUFA fees are waived Smaller patient numbers are required for clinical trials No other version of the drug will be approved during a seven year market exclusivity Tax incentives are given to the manufacturer Clinical trial requirement is waived What is not true of biosimilars? Cardiotoxicity studies may not be required of a biosimilar if branded drug has no known cardiotoxicity issues Cardiotoxicity studies are required for approval of biosimilars Animal and human clinical studies on safety and efficacy are still required of biosimilars Biosimilars are generally sold at much lower prices than branded biologics Biosimilars are not meaningfully different from the branded product in terms of safety and efficacy Cardiotoxicity studies are required for approval of biosimilars Many biotech companies do not have the capacity to do all drug manufacturing activities on their own and have to rely on CMOs. CMO stands for: Chinese mandarin oranges Contract manufacturing organization Consolidated manufacturing organization Contract management organization Commercialization management organization Contract manufacturing organization FDA defines a drug as any substance used for diagnosis, control, mitigation, prevention or treatment of disease. In drug regulation, the use of a drug for a particular disease or condition is referred to as its: Abuse Component Prescription Indication Active pharmaceutical ingredient indication Many biologics are manufactured using living cells. What is not a main concern of the process development group of a biologics manufacturer? Optimizing product yield of the host cells in the bioreactor Improving the ease of growing the production cells Optimizing yield of formulated product through improved purification process File the drug marketing application with the FDA Minimize the possible loss of the recombinant DNA in the production cells File the marketing application with the FDA Generic drugs have certain properties that should be the same as brand name drugs. What is not expected to be the same in a generic and in a branded drug? Same container and closure Same active ingredient Same dosage form Same route of administration Safe to patients Same strength Same container and closure Drug product refers to a finished dosage form. What is not considered a dosage form? Syrups Injectables Elixir Cream Capsules Artificial sweetener Artificial sweetener What is not true of the inactive ingredients found in drug products? Inactive ingredients are considered drug contaminants Inactive ingredients include starch binders in tablets Inactive ingredients are a common component of drug products Inactive ingredients include artificial colorants or preservatives Inactive ingredients can affect the safety and efficacy properties of a drug product Inactive ingredients are considered drug contaminants Prior to release for marketing, one critical quality attribute of any drug product that needs to be met is strength. What is not a unit of strength? Number of tablets per container Weight of the API per capsule Weight of the API per tablet Amount of API per unit volume International units or IU Number of tablets per container