180 day exclusivity - Study guides, Class notes & Summaries

CNPR Final Exam Questions and Answers Latest Updated 2023/2024 | 100% Verified. Bioavailablility - ANSWER how quickly and how much of a drug reaches its intended target site of action Bioequivalent - ANSWER when drugs contain not only the same active ingredients but also produce virtually the same blood levels over time Therapeutic equivalence - ANSWER production of the same medicinal effects Areas of drug elimination and excretion - ANSWER Lungs, breast milk, sweat tears urine feces, bile...

VA State Exam With Complete Questions And Answers Which of these is a rule that governs how escrow money can be disbursed? Brokers can disburse escrow money at the conclusion of the transaction to settle the agreement between the parties. Brokers can disburse escrow money in a different way than the contract indicates. If the contract doesn't give any instructions about the escrow account, the money always goes back to the client who paid it. Licensees must open an escrow account on the...

30-day hold - correct answer (aka 30-day safety review) Time frame between filing a protocol under an IND and the FDA approval to proceed with enrollment. Also, the time period between when a company submits an IND and when it can initiate a protocol. This timeline may be extended if FDA does not agree with the proposed protocol. (see "Clinical Hold.") 120-day Safety Report - correct answer Amendme...

VA State Exam With Complete Questions And Answers Which of these is a rule that governs how escrow money can be disbursed? Brokers can disburse escrow money at the conclusion of the transaction to settle the agreement between the parties. Brokers can disburse escrow money in a different way than the contract indicates. If the contract doesn't give any instructions about the escrow account, the money always goes back to the client who paid it. Licensees must open an escrow account on the...

Margin of safety - the difference between the usual effective dose and the dose that induces severe or life-threatening side effects Rights of drug administration - right patient, right medication, right does, right route of administration, and right time of delivery Injection routes - intramuscular, intrathecal, intravenous, subcutaneous intramuscular - drugs given by direct injection into muscle tissue intrathecal - needle is inserted between to vertebrea in the lower spine an into space a...

RAC Glossary 2023 Review Update 21st Century Act - ANS-Amends FD&C Act and PHS Act to include provisions for: patient focused drug development, advancing new drug therapies, modern trial design and evidence development, patient access to therapies and information, antimicrobial innovation and stewardship, medical device innovations, improving FDA expertise and outreach, medical countermeasures innovation, vaccine access, certainty and innovation. 30-Day hold - ANS-Time period between f...

Pharmaceuticals - medicines and vaccines for human and animal use. products may have a brand name or be generic, and they may be prescription or OTC Diagnostic - equipment and supplies used in screening, detecting, and monitoring disease. can range from simple home testing kits to sophisticated imaging technologies Medical devices - advanced instrumentation and appliances used for medical therapy, such as joint replacements, implantable defibrillators, and pacemakers. Also includes drug delive...

Drug Discovery - • Unlike small molecule drugs (pharmaceuticals), large molecule drugs (biopharmaceuticals) are mainly protein-based o These protein-based drugs are similar to natural biological compounds found in human body or they're fragments that mimic active part of natural compounds Discovery of Pharmaceuticals - commences w/ scanning hundreds of compounds, whether w/ actual materials (irrational approach) or virtual simulations (rational approach) • Pharmaceuticals are new che...

Pharmaceuticals are arguably the most socially important healthcare product. (T/F) - true Pharmaceutical development is a high-risk undertaking, in which many promising leads prove disappointing. (T/F) - true Pharmaceutical sales are highest in which geographical regions? - The U.S., Western Europe, and Japan The U.S. accounts for about of the world's pharmaceutical revenues. - 50% Which of the following has fueled recent growth in the pharmaceutical industry? - population growth and inc...

CNPR NAPSR Exam Margin of safety - ANS the difference between the usual effective dose and the dose that induces severe or life threatening side effects Rights of drug administration - ANS right patient, right medication, right does, right route of administration, and right time of delivery Injection routes - ANS intramuscular, intrathecal, intravenous, subcutaneous intramuscular - ANS drugs given by direct injection into muscle tissue intrathecal - ANS needle is in...