What does ind - Study guides, Class notes & Summaries

NURS 5334 - FINAL EXAM STUDY GUIDE. Final Exam Blueprint Prescribing Basics: 2 questions Prescriptive authority regulated by the state BON in each state. Tall man lettering to highlight dissimilaries with look-alike names *Prescription contains… Physicians Name, Address, and telephone number are required to be included in the prescription. DEA number (two letters, five numbers) if the prescription is for controlled substance, Patient name and DOB (also may include address and wei...

PTCB EXAM TEST BANK QUESTIONS AND ANSWERS LATEST WITH RATIONALE Multiple choice What is the route of administration for a prescription with the following directions: "i supp pr q 6 hr prn"? A. Orally B. Rectally C. Urethrally D. Vaginall {{Correct Ans- B. Rectally Rationale: "pr" means per rectum. What is the meaning of PDA? A. Personal digital aid B. Personal digital assistant C. Physician digital assistant D. Pharmaceutical data assistant {{Correct Ans- B. Personal digital...

Safety Management IIA - MNO2603 MON2603 ASSESSMENT 4 SEMESTER 2 2024. There are direct and indirect costs of incidents and accidents. What does indirect costs include? a. Repair of damaged facilities. b. Increased insurance premiums. c. Damage to the business image of reputation.  d. Legal fees. What is the correct term used to refer to the economic and legal responsibilities of any business in order to have a positive impact on society by going beyond the interest of the b...

SOCRA EXAM PREP | 2023 Update | Questions and Verified Answers| Highly Rated Guide Q: What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? Answer: 1) Progress of investigations under IND 2) Secure compliance or discontinue investigators that are not compliant and notify FDA 3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 4) Notify FDA, all IRBs and all investigators if drug presen...

SOCRA EXAM PREP | 2024 / 2025 Newly Updated | Questions and Verified Answers | Highly Rated Guide Q: What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? Answer: 1) Progress of investigations under IND 2) Secure compliance or discontinue investigators that are not compliant and notify FDA 3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 4) Notify FDA, all IRBs and all investigators if drug pr...

NR546 Midterm Exam Are the PMHNP and other staff liable if the client has an allergic reaction or adverse side effects to the drugs used for chemical restraint? - Answer-No. The client has been court-ordered to take the prescribed medications and the standing order for chemical restraints is approved. The PMHNP and other staff are not liable if the patient has an allergic reaction or adverse side effects. How does reviewing the genetic makeup of a client help guide the PMHNP in selec...

CITI Training 134 QUESTIONS Graded A+ Solved 2023 What must you file before conducting human clinical trials with an experimental drug? Correct Answer: IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? Correct Answer: Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this document notifies FDA of relevant...

Indiana Pesticide Applicator Core Exam (MAIN REVIEW)| UPDATE|COMPREHENSIVE QUESTIONS AND VERIFIED SOLUTIONS/CORRECT ANSWERS|GET 100% ACCURATE!! What is FIFRA and what does it regulate? - ANSWER>>Federal Insecticide, Fungicide, and Rodenticide Act -regulates pesticide distribution, sales, and use How are pesticides regulated? - ANSWER>>Product Labels What does RUP stand for? - ANSWER>>Restricted Use Pesticide What is a liquid flowable? - ANSWER>>The powder is mixed...

Drug Development is initiated by the discovery of what compound? Correct Answer-Lead What is used to produce penicillin? Correct Answer-Fungi After the animal testing, the drug may be used for clinical testing of human studies. What is the drug called during this phase? Correct Answer-Investigational New Drug (IND) How many phases does a clinical trial have? Correct Answer-4 Phases What is Phase 1 of a Clinical Trial? Correct Answer-Targeting drug safety in humans In this phase of...

When isn't an IND application needed? - Answer - IND Application is not needed if investigation does not support change in labeling. What information must the general IND include? (21 CFR Part 312.23) - Answer - -FDA Form 1571 -FDA Form 1571 cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research/literature information -Additional information (drug dependence and a...