Pharmacovigilance in Clinical Trails
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https://doi.org/10.22270/ajprd.v14i2.1719Abstract
An essential component of the entire drug development process is pharm acovigilance. Pharmacovigilance is the ongoing observation, assessment, and interpretation of possible side effects or other problems pertaining to medications. By weighing the advantages and disadvantages of particular medications, this promotes patient safety. Pharmacovigilance has been more effective with the use of information technology, allowing for improved monitoring and clinical safety procedures. It is essential to ensuring the cost-effectiveness, safety, and efficacy of medications over their entire lifecycle, from research to postmarketing monitoring. ICH GCP, USFDA standards, and other regulatory g uidelines regulate the clinical trial procedure.The evidence underpinning for regulatory judgments about safe and effective medications is provided by clinical studies. A crucial part of every stage of the drug development life cycle is safety evaluation A crucial part of every stage of the drug development life cycle is safety evaluation. The ultimate objective of pharmacovigilance in clinical trials is to monitor and evaluate the test product's safety profile.
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Kanala K, Hwisa NT, Chandu BR, Assaleh FH, Mukkanti K, Katakam P, Challa BS. Simultaneous quantification of mesalamine and its metabolite N-acetyl mesalamine in human plasma by LC-MS/MS and its application to a bioequivalence study. Br J Pharm Res. 2014;4(13):1568. Available from: https://www.ijpsjournal.com
De Carvalho PM, et al. Brazilian regulation in pharmacovigilance: a review. Pharmaceut Reg Affairs. 2016;5:164.
Härmark LV. Web-based intensive monitoring: a patient-based pharmacovigilance tool. EPRA Journal. [Internet]. Available from: https://doi.org/10.36713/epra15259
Muhannad RS, Arwa YA, Omer QBA, Ramdan ME, Kurmanji JM. Psychometric evaluation of physicians toward pharmacovigilance practice in Iraq. J Pharmacovigilance. 2016;4(214):2–3.
Singh S, Prakash J, Goyal N, Tomar R, Chaudhary R. Pharmacovigilance. World J Pharm Pharm Sci. 2015;4(6):271–273.
Kandi V, Vadakedath S. Clinical research: an overview of study types, designs, and implications in the public health perspective. Am J Clin Med Res. 2021;9(2):36–42.
Kengar MD, Patole KK, Ade AK, Kumbhar SM, Patil CD, Ganjave AR. Introduction to pharmacovigilance and monitoring. Asian J Pharm Res. 2019;9(2):116–122.
Mane SR, Bais SK, Gavade SK. Novel approaches in pharmacovigilance. Int J Pharm Clin Res. 2024;2(1):1414–142.
Mazzitello C, et al. Pharmacovigilance in Italy: an overview. J Pharmacol Chemother. 2013;4(1 Suppl):S20–S28.
Fitzpatrick S. The clinical trial protocol. Institute of Clinical Research; 2005.
Kinders R, et al. Phase 0 clinical trials in cancer drug development: from FDA guidance to clinical practice. Mol Interv. 2007;7(6):325.
DiMasi JA. Risks in new drug development: approval success rates for investigational drugs. Clin Pharmacol Ther. 2001;69(5):297–300.
Friedhoff LT. New drugs: an insider’s guide to the FDA’s new drug approval process for scientists, investors, and patients. PSPG Publishing; 2009.
Gibbons RD. Post-approval drug safety surveillance. Annu Rev Public Health. 2010;31(1):419–437.
Pirmohamed M, James S, Meakin S, Green C, Scott A. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ. 2004;329(12):15–19.
Fletcher AP. Spontaneous adverse drug reaction reporting vs event monitoring: a comparison. J R Soc Med. 1991;84(6):341–344.
Alvarez-Requejo A, Carvajal A, Begaud B, Moride Y, Vega T, Martin Arias LH. Under-reporting of adverse drug reactions: estimate based on a spontaneous reporting scheme and a sentinel system. Eur J Clin Pharmacol. 1998;54(20):483–488.
Pirmohamed M, Breckenridge A, Kitteringham NR, Park BK. Adverse drug reactions. BMJ. 1998;316(23):1295–1298.
Hama R. The mechanisms of adverse reactions to oseltamivir: part II. delayed type reactions. Clin Microbiol. 2015;4:224.
Klepper MJ. The periodic safety update report as a pharmacovigilance tool. Drug Saf. 2004;27:569–578.
Kowalski CJ, Mrdjenovich AJ. Pharmacovigilance observed: why watchful waiting will work. J Clin Diagn Res. 2015;3:114.
Pisipati SV, Pathapati H, Bhukya G, Nuthakki S, Chandu B, Nama S, Adeps R. Lycopene: redress for prostate cancer. J Basic Clin Pharm. 2012;3(2):261.
Franklin JM, Glynn RJ, Martin D, Schneeweiss S. Evaluating the use of nonrandomized real‐world data analyses for regulatory decision making. Clin Pharmacol Ther. 2019;105(4):867–877.
Waller P, Mann RD. Pharmacovigilance: principles and database systems. Wiley; 2002.Mann RD. Pharmacovigilance: a practical approach. Wiley; 2007.
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