Volume : 11, Issue : 04, April – 2024
Title:
A REVIEW ON PRECLINICAL PHARMACOLOGY AND TOXICOLOGY
Authors :
Kukkannagari Sai Nuthan Raju and Dr.R. Jona methusala
Abstract :
Preclinical pharmacology and toxicology are essential elements of the drug discovery and development process and are critical in enabling the translation of findings from the laboratory and the clinic. The drug discovery process is complex and involves numerous iterative steps designed to optimize the pharmacological and drug-like properties of a candidate molecule, a New Chemical Entity (NCE), and minimize the potential for side effects and toxicities. Key concepts addressed in this record include: compound identification; lead optimization; pharmaceutical profiling; the use of animal models to predict efficacy and safety and toxicological assessment as these relate to the regulatory requirements for Phase I trial initiation. Commentary is also provided on the current challenges associated with translational medicine as it applies to the effective evolution of candidate NCEs into viable clinical candidates.
Cite This Article:
Please cite this article in press Kukkannagari Sai Nuthan Raju et al., A Review On Preclinical Pharmacology And Toxicology., Indo Am. J. P. Sci, 2024; 11 (04).
Number of Downloads : 10
References:
1.BYETTA (exenatide) injection prescribing information. Revised December 2011. Available from: http://www.byetta.com.
2.Young AA, Gedulin BR, Bhavsar S, Bodkin N, Jodka C, Hansen B, Denaro
3.M. Glucose-lowering and insulin-sensitizing actions of exendin-4. Studies in obese diabetic (ob/db/db) mice, diabetic fatty Zucker rats, and diabetic Rhesus monkeys (Macaca mulatta). Diabetes 48:1026-1034, 1999.
4.Kolterman OG, Kim DD, Shen L. Ruggles JA, Nielsen LL, Fineman MS, Baron AD. Pharmacokinetics, pharmacodynamics, and safety of exenatide in patients with type 2 diabetes mellitus. Amer J Health Sys Pharmacy. 2005:62:173-181.
5.Cirincione B, Edwards J, Aisporna M, MacConell L. Gastrointestinal tolerability with twice-daily or once-weekly exenatide formulations was not predicted by concentration with long-term treatment. Diabetologia. 2013;56 Suppl 1:S363.
6.https://aasayurveda.com/diabetes-treatment-in ayurveda/
7.Young, A.A., Gedulin, B.R., Bhavsar, S. et al. Glucose-lowering and insulin- sensitizing ac- tions of exendin-4: studies in obese diabetic (ob/ob, db/db) mice, diabetic fatty Zucker rats, and diabetic rhesus monkeys (Macaca mulat- ta). Diabetes 1999, 48: 1026-34.
8.Onozato ML, Tojo A, Goto A, Fujita T, Wilcox CS. Oxidative stress and nitric oxide synthase in rat diabetic nephropathy: effects of ACEI and ARB. Kidney Int. 2002;61:186-94, doi: 10.1046/j.1523-1755.2002.00123.x.