Genotoxicity - Study guides, Class notes & Summaries

Hazardous Drug Any drug identified by at least one of the following six criteria: • Carcinogenicity • Teratogenicity or developmental toxicity • Reproductive toxicity in humans • Organ toxicity at low doses in humans or animals • Genotoxicity • New drugs that mimic existing hazardous drugs in structure or toxicity

A medical device manufacturer is preparing a submission that requires a Declaration of Conformity with design control requirements. What type of submission is the manufacturer preparing to submit to FDA? 0 A PMA 1 A Special 510(k), 2 An Individual Device Exemption (IDE), 3 An Annual Report for a PMA - A Special 510(k) A company wishes to expand existing labeling for a medical device to include a new indication for use. What action should the regulatory professional take FIRST? - Contact t...

Chemo certification renewal Questions and Answers 100% Pass The standard states that gowns must: A. be disposable B. not have any closures or seams that HDs can pass through C. be changed every shift if there are no specific manufacturer recommendations D. both a & b - Correct Answer ️️ -D. both a & b Which of the following is a general recommendation regarding the administration of hazardous drugs? A. A NIOSH-approved respirator is required for all intravenous administration. B. R...

When chemotherapy is used before primary treatment (surgery) to reduce the size of a solid tumor, it is called what? - Neoadjuvant Therapy Which of the following class of drugs is cell cycle non-specific and therefore can affect the cancer in any phase of the cell cycle? - Alkylating Agents Mutations in genetic material from exposure to chemotherapy are termed? - Genotoxicity The Vinca Alkaloids act in which phase where they prevent cell division? - M Phase Which of the following is likely...

CHEMO CERTIFICATION RENEWAL EXAM / QUESTIONS AND VERIFIED ANSWERS 2023/2024 / GRADED A+. 2 / 6 1. The standard states that gowns must: A. be disposable B. not have any closures or seams that HDs can pass through C. be changed every shift if there are no specific manufacturer recommenda-tions D. both a & b ANSW D. both a & b 2. Which of the following is a general recommendation regarding the admin-istration of hazardous drugs? A. A NIOSH-approved respirator is required for all intrave...

Chemo Certification Renewal Exam The standard states that gowns must: A. be disposable B. not have any closures or seams that HDs can pass through C. be changed every shift if there are no specific manufacturer recommendations D. both a & b - D. both a & b Which of the following is a general recommendation regarding the administration of hazardous drugs? A. A NIOSH-approved respirator is required for all intravenous administration. B. Reuse of gowns is appropriate if the...

Which organization first used the term hazardous drugs? ASHP OSHA NIOSH Oncology Nursing Society (ONS) - ASHP Which term defines hazardous drugs as damaging the developing fetus? Carcinogenicity Teratogenicity Genotoxicity Reproductive toxicity - Teratogenicity As the use and number of these potent drugs increase, so do opportunities for hazardous exposures among health care workers. T or F - True Which term is most preferred when discussing drugs that may put workers exposed to them...

3S Oncology Chemo Certification Exam 2024/2025 100% Solved Grade A+ When chemotherapy is used before primary treatment (surgery) to reduce the size of a solid tumor, it is called what? - Neoadjuvant Therapy Which of the following class of drugs is cell cycle non-specific and therefore can affect the cancer in any phase of the cell cycle? - Alkylating Agents Mutations in genetic material from exposure to chemotherapy are termed? - Genotoxicity The Vinca Alkaloids act in which phase w...

Which organization first used the term hazardous drugs? ASHP OSHA NIOSH Oncology Nursing Society (ONS) - ASHP Which term defines hazardous drugs as damaging the developing fetus? Carcinogenicity Teratogenicity Genotoxicity Reproductive toxicity - Teratogenicity As the use and number of these potent drugs increase, so do opportunities for hazardous exposures among health care workers. T or F - True Which term is most preferred when discussing drugs that may put workers exposed to them...

declaration of helsinki (1964) correct answers-ethical principles (31) for research with human subjects -international standard -subjects take precedence -combing research and clinical care -adapted from Nuremberg Code by the World Medical Association ICH - international conference on harmonisation correct answersinternational authority on clinical research theory and principles ICH guidelines correct answers4 major categories QUALITY - chemical/pharm. Assurance (stability testin...