In pharmaceutical discovery and development, many drug substances and their formulations are generated. However, the vast majority of these compounds will not be suitable as final products for commercialization. Prior to commericialization, a novel molecular entity (NME) must demonstrate appropriate efficacy and safety preclinically and clinically in addition to offering an unique selling point and effective treatment to address an unmet medical need.
The process of bringing a novel medicine to market is long, expensive and challenging. In pharmaceutical discovery and development, many drug substances and their formulations are generated. However, the vast majority of these compounds will not be suitable as final products for commercialization. Prior to commericialization, a novel molecular entity (NME) must demonstrate appropriate efficacy and safety preclinically and clinically in addition to offering an unique selling point and effective treatment to address an unmet medical need.
In pharmaceutical drug discovery and development, many candidate compounds have been generated. However, the vast majority of these compounds fail to meet the specific criteria for further development. Pharmacokinetic characterization can play an important role in evaluating the properties of novel chemical entities (NCEs) to determine their successful entry into preclinical studies and clinical trials.
Many pharmaceutical candidates are generated from early drug discovery to late development. Of these, the vast majority will not be commercialized. Therefore, these compounds must demonstrate appropriate efficacy, safety, and tolerability in order to qualify as an NME. A primary objective of drug discovery is to generate new compounds with desirable pharmacokinetic properties in order to achieve a favorable therapeutic profile.
Toxicology studies evaluate drug exposure for adverse effects and therapeutic index during preclinical development. FDA requires toxicological studies in a minimum of two animal species before first in human (FIH) dosing. Generally, one of the selected species for in vivo toxicology studies may be rodent and the other must be non-rodent. Toxicology studies span various designs, including single or acute dose toxicity study, dose range finding (DRF) study, maximum tolerated dose (MTD) study, and repeated dose toxicity studies. We conduct regulated nonclinical tox studies using Good Laboratory Practices (GLP) under 21 CFR part 58. Our toxicology services include routine GLP toxicokinetic (TK) studies and Non-Compartmental Analysis for dose ranging studies.
Good Laboratory Practice (GLP) toxicology studies are conducted in compliance with the requirements of 21 CFR 50, parts 58 and 58.123 by credentialed scientists in a controlled laboratory environment. GLP toxicological studies evaluate the safety of drugs, chemicals and other substances for humans and animals. Credentialed scientists use GLP to provide reliable data related to adverse effects and therapeutic index during preclinical development of new drugs or medical products.
In vivo toxicology studies evaluate drug exposure for adverse effects and therapeutic ind studies index during preclinical development. We conduct regulated nonclinical tox studies using Good Laboratory Practices (GLP) under 21 CFR part 58. Our toxicology services include routine GLP toxicokinetic (TK) studies and Non-Compartmental Analysis for dose ranging studies. Toxicokinetic (TK) study helps quantitate the systemic exposure time course for prodrugs, drugs, and metabolites.
Our toxicology services include routine GLP toxicokinetic (TK) studies and Non-Compartmental Analysis for dose ranging studies.
