Glp Study guides, Class notes & Summaries

GLP 2023 Good Laboratory Practice - deals with how nonclinical laboratory studies are planned, performed, monitored, and recorded. 1976: Industrial Bio‐Test Laboratories (IBT) - Fabrication of data Replacement of dead study animals with healthy ones Changes in raw data to make them fit the result tables i Regulations for Good Laboratory Practices (GLP) were created when and why - 1979 Poorly‐trained Study Directors and study personnel Poorly‐designed protocols Protocols not follo...

GLP-1 Agonists Exam Review 2023 What is a GLP-1 agonist? - ANS-A longer acting analog of GLP-1 (longer than the endogenous GLP-1); activates the GLP-1 receptor How can GLP-1 affect the body? - ANS-Increases amount of insulin produced BEFORE BG elevates (increase beta cell function), lowers glucagon secretion after meals (decrease glucose production), increases CNS satiety (decrease food intake), slows gastric emptying (decrease glucose absorption), and increases glucose uptake into s...

GLP Exam Review 2023 FDA - food and drug adminstration EPA - environmental protection agency OECD - organization for economic cooperation and development CFR - code of federal regulation GMP - good manufacturing practice GCP - good clinical practice SOP - standard operating procedure NDA - new drug application QAU - quality assurance unit GLP regulations apply to phase I, II, III clinical trials - FALSE Extensive scientific fraud at industrial bio-test laboratories triggered the early...

ACHPN Questions And Answers With Verified Solutions 2023 What route are GLP-1 receptor agonists Correct Answer: SUB-Q except for semaglutide which is PO What are the 4 medicines of GLP-1 agonists Correct Answer: 1. liraglutide 2. Lixisenatide 3. Semaglutide 4. exenatide What are the 4 DDP-4 inhibitors? Correct Answer: 1. sit gliptin 2. saxagliptin 3. linagliptin 4. algogliptin what are the 4 SLGT-2 inhibitors? Correct Answer: 1. dapagliflozin 2. canagliflozlin 3. empagliflozin ...

Good Laboratory Practices (GLP) Exam 2023 Scope of GLPs - ANS-GLPs prescribe good laboratory practices for conducting *NONCLINICAL laboratory studies* that support applications for research/marketing permits for FDA-regulated products What products do GLP apply to? - ANS--food, animal and color additives -human and animal drugs -devices -biological and electronic products What do GLPs NOT cover? - ANS--human subjects -basic exploratory research What is the intent of the GLPs? - ANS-...

PHARMACOLOGY FINAL EXAM TESTBANK- CORRECT AND VERIFIED GUIDE 1. Both men and women experience bone loss with aging. The bones most likely to demonstrate significant loss are: a. Cortical bones b. Femoral neck bones c. Cervical vertebrae d. Pelvic bones 2. Bisphosphonates treat or prevent osteoporosis by: a. Inhibiting osteoclastic activity b. Fostering bone resorption c. Enhancing calcium uptake in the bone d. Strengthening the osteoclastic proton pump 3. Prophylactic use of bisphospho...

LP and GMP Principles Review Test 2023 What does GLP stand for? - ANS-good laboratory practices What does GMP stand for? - ANS-good manufacturing practices When were biologics manufactured on a large scale? - ANS-1980 What does CDER stand for? - ANS-Center for Drug Evaluation and Research What does the CDER regulate? - ANS-small molecules and drugs What does CBER stand for? - ANS-Center for Biologics Evaluation and Research What does CBER regulate? - ANS-biologics Which agency regulates ...

GMP, GLP & GDP Questions And Answers 2023 What is the role of OA in a GLP study? - ANS-Make sure documentation is done correctly. What is the role of QA in a GMP environment? - ANS-Make sure documentation is done correctly (batch records, SOPs) Work with CAPA What is the essence of GDP? - ANS-If it's not documented, it didn't happen. What is the purpose of GDP? - ANS-To prove the manufacturer did what it said it would do. To comply with FDA regulations. To discover the root cause ...

NAPLEX Practice Exam Questions & answers 2023Which of the following is true regarding niacin formulations? Answer A Niaspan is controlled-release niacin; it causes less flushing but more hepatotoxicity. B Niaspan is extended-release niacin; it causes less flushing and less hepatotoxicity. C Slo-Niacin is sustained-release niacin; it causes less hepatotoxicity but is the most expensive agent. D Slo-Niacin is interchangeable with other niacin formulations. E Niacin decreases both LD...

Medicine GLP-1 Exam 2023 What is Glucagon-like peptide-1 ? - ANS-An incretin derived from the transcription product of the proglucagon gene. A gut hormone = an incretin. An antihyperglycemic peptide that is glucose-dependent in action. How is GLP-1 glucose-dependent ? - ANS-Released from L-cells in the intestine in blood stimulated by secretagogues, food containing carbohydrate, protein, lipid. The biologically active forms of GLP-1 are: - ANS-GLP-1-(7-37) and GLP-1-(7-36)NH2. Those ...