BTEC 3317 EXAM 2 UH Questions with correct Answers

[Manufacturing Plan] As part of a robust manufacturing plan, to increase assurance of consistency in product quality from batch to batch of manufactured drug, part of the manufacturing plan is to have ___________ in place. " - Answer- process validation plan [PCR procedures] Which drug development department may be responsible for developing PCR procedures to test for the proper integration of a gene therapy construct in the genome of treated patients? - Answer- Assay development group [Strength-a] 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? - Answer- Number of tablets per container [Strength-b] What is a unit of strength? - Answer- 1) Weight of the API per capsule 2) International units or IU 3) Weight of the API per tablet 4) Amount of API per unit volume [Drug Regulation Parlance] FDA defines a drug as any substance used for diagnosis, control, mitigation, prevention or treatment of disease. In drug regulation parlance, the use of a drug for a particular disease or condition is referred to as its: - Answer- Indication [Combination Drug Product] 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? - Answer- Estrogen patches [Biosimilars-a]What is not true of biosimilars? - Answer- Biosimilars need to be at a higher strength than the branded counterparts [Biosimilars-b] What is true of Biosimilars? - Answer- 1) A biosimilar has the same active ingredient as branded biologic 2) Biosimilars are not meaningfully different from the branded product in terms of safety and efficacy 3) Animal and human clinical studies on safety and efficacy are still required of biosimilars 4) "For biosimilars, PREA requirements for testing in children are waived" [Marketed Drug Product] "__________ means any ingredient used in the manufacture of a drug product, including those that may not appear in the marketed drug product." - Answer- Component [Process Development Group-a] Many biologics are manufactured using living cells. What is not a concern of the process development group of a biologics manufacturer? - Answer- Increasing the number of patients who will use the manufactured drug [Process Development Group-b] Many biologics are manufactured using living cells. What is a concern of the process development group of a biologics manufacturer? - Answer- 1) Optimizing yield of formulated product through improved purification process 2) Improving the ease of growing the production cells 3) Minimize the possible loss of the recombinant DNA in the production cells 4) Optimizing product yield of the host cells in the bioreactor [Drug Development Process-a] From the Roche video, what is the last step in the drug development process? - Answer- Providing regulatory agencies with documentation to support marketing approval [Drug Development Process-b] what are the steps in the drug development process? - Answer- 1st) Identifying a molecular drug target 2nd) Identifying a first lead compound 3rd) Lead Optimization 4th) Preclinical safety and efficacy trials 5th) Clinical trials in man 6th) Regulatory approval and launch [New Drug-a] 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? - Answer- Two tablets that separately contain two different APIs will be preferred over one tablet that contains both APIs [New Drug-b] What is 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? - Answer- 1) The currently marketed drug is injectable while the new drug will be oral 2) A new cancer drug that does not cause nausea will be preferred over an existing one that does 3) "For any given drug, more than 50% of patients with a condition may not respond to the existing drug" 4). The currently marketed drug is very expensive [Ingredients-a] Most drugs in all different dosage forms contain active and inactive ingredients. What is not true of inactive ingredients? - Answer- The drug component primarily responsible for control, mitigation, treatment or prevention of disease [Ingredients-b] What is true of inactive ingredients? - Answer- 1) Inactive ingredients can affect the safety and efficacy properties of a drug product 2) Inactive ingredients are a common component of drug products 3) Inactive ingredients include artificial colorants or preservatives 4) Inactive ingredients include starch binders in tablets [Pharmaceutical Regulation] The FDA office that regulates pharmaceutical and some biologic drugs including antibodies and growth factors is the: - Answer- Center for Drug Evaluation and Research [Comparability Studies & Tests] Which group in a drug development company performs comparability studies or tests of different product attributes from one manufacturing batch to another? - Answer- Quality control group [Market Analysis] You're tasked with doing market analysis for the new drug that your company is developing. What might decrease the future market earnings for your new drug? - Answer- There's a drug under development that is in a more advance stage of clinical trials [Orphan Drugs-a] 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?" - Answer- PDUFA fees are reduced by 90% [Orphan Drugs-bWhat is an incentive given to manufacturers to encourage the development of orphan drugs?" - Answer- 1) Clinical research subsidies are provided 2) No other version of the drug will be approved during a seven year market exclusivity 3) Smaller patient numbers are required for clinical trials 4) Tax incentives are given to the manufacturer [IND Study Plan-a]An IND includes details on the plan for clinical testing. What information may not appear in the study plan for clinical testing? - Answer- Professions of the test subjects [IND Study Plan-b] An IND includes details on the plan for clinical testing. What information may appear in the study plan for clinical testing? - Answer- 1) Qualifications of clinical investigators 2) A science-based justification for testing in humans 3) Description of possible risks to subjects and strategies for protection of subjects 4) Commitment to obtain informed consent from subjects [Informed Consent-a] Choose the best answer. What does not apply to informed consent? - Answer- Participants are informed that they won't be exposed to any health risks during the trial