Animal species, i.e. rats, are used to evaluate a drugs biol. activity and pharmacokinetics, such as clearance.This study aims to develop a predictive method to evaluate the relationship between the clearance of drugs in rats and humans.Adataset of 395 drugs composed of human and rat clearance data was applied in this study.The drugs, according to the clearance differences, were divided into two groups on the basis of the correlation between humans and rats.Structural parameters were used to develop a model to estimate the class of each drug by binary logistic regression.The results showed that the developed models are a useful way to show which drug have an acceptable correlation between human and rat clearance by using structural features.They can be used to determine the group of drugs with an accuracy of 74%.According to the validation results, the developed method has an acceptable accuracy for checking the relationship between the clearance of drugs in humans and rats.This modeling can be used to exclude the drugs from experiments in rats which reveal a considerable difference between the clearance of humans and that of rats.

01 Jan 2016·The AAPS journalQ3 · MEDICINE

BDDCS Predictions, Self-Correcting Aspects of BDDCS Assignments, BDDCS Assignment Corrections, and Classification for more than 175 Additional Drugs

Q3 · MEDICINE

Review

Author: Chan, Rosa ; Benet, Leslie Z ; Hosey, Chelsea M

The biopharmaceutics drug disposition classification system was developed in 2005 by Wu and Benet as a tool to predict metabolizing enzyme and drug transporter effects on drug disposition. The system was modified from the biopharmaceutics classification system and classifies drugs according to their extent of metabolism and their water solubility. By 2010, Benet et al. had classified over 900 drugs. In this paper, we incorporate more than 175 drugs into the system and amend the classification of 13 drugs. We discuss current and additional applications of BDDCS, which include predicting drug-drug and endogenous substrate interactions, pharmacogenomic effects, food effects, elimination routes, central nervous system exposure, toxicity, and environmental impacts of drugs. When predictions and classes are not aligned, the system detects an error and is able to self-correct, generally indicating a problem with initial class assignment and/or measurements determining such assignments.

01 Nov 2011·Xenobiotica; the fate of foreign compounds in biological systemsQ4 · MEDICINE

Interspecies scaling and prediction of human clearance: comparison of small- and macro-molecule drugs

Q4 · MEDICINE

Article

Author: Smith, David E. ; Feng, Meihau Rose ; Huh, Yeamin

Human clearance prediction for small- and macro-molecule drugs was evaluated and compared using various scaling methods and statistical analysis. Human clearance is generally well predicted using single or multiple species simple allometry for macro- and small-molecule drugs excreted renally. The prediction error is higher for hepatically eliminated small-molecules using single or multiple species simple allometry scaling, and it appears that the prediction error is mainly associated with drugs with low hepatic extraction ratio (Eh). The error in human clearance prediction for hepatically eliminated small-molecules was reduced using scaling methods with a correction of maximum life span (MLP) or brain weight (BRW). Human clearance of both small- and macro-molecule drugs is well predicted using the monkey liver blood flow method. Predictions using liver blood flow from other species did not work as well, especially for the small-molecule drugs.

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Indication	Highest Phase	Country/Location	Organization	Date
Angina Pectoris	Phase 2	Italy	Italfarmaco SpA	-
Angina Pectoris	Phase 2	-	Italfarmaco SA	-
Myocardial Infarction	Phase 2	-	Italfarmaco SA	-
Myocardial Ischemia	Phase 2	European Union	-	-
Hypertension	Clinical	Italy	Italfarmaco SpA	-

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