Complement opsonization of nanoparticles: Differences between humans and preclinical species

2021 ◽  
Author(s):  
Yue Li ◽  
Guankui Wang ◽  
Lynn Griffin ◽  
Nirmal K. Banda ◽  
Laura M. Saba ◽  
...  
Keyword(s):  
Preclinical Species

Hypothermia associated with a putative ophthalmic therapeutic in preclinical species

2018 ◽  
Vol 93 ◽  
pp. 149
Author(s):  
Kathy Derakhchan ◽  
Anneli Savinainen ◽  
Jennifer Newman ◽  
Serene Josiah ◽  
Galen Carey
Keyword(s):  
Preclinical Species

scholarly journals Prediction of Human Pharmacokinetics of Bendamustine from Preclinical Species Pharmacokinetics Based on Normalizing Time Course Profiles

Drug Research ◽  
2018 ◽  
Vol 69 (01) ◽  
pp. 32-39 ◽  
Author(s):  
Nuggehally Srinivas ◽  
Ravi Jairam ◽  
Sadanand Mallurwar ◽  
Suresh Sulochana ◽  
Devaraj Chandrasekar ◽  
...  
Keyword(s):  
Intravenous Infusion ◽  
Time Course ◽  
Animal Species ◽  
Anticancer Agent ◽  
Time Profile ◽  
Lymphocytic Leukemia ◽  
Human Pharmacokinetics ◽  
Correction Factors ◽  
Preclinical Pharmacokinetics ◽  
Preclinical Species

AbstractBendamustine, an alkylating anticancer agent, is used to treat chronic lymphocytic leukemia by intravenous infusion alone or in combination. The work aimed to develop a method to predict time vs. concentration profile for humans based on preclinical pharmacokinetics using the assumption of superimposability of normalized time course profiles of animals and humans. Standard allometric equations with/without correction factors (CF) were also used in prediction. The Vss was predicted by simple allometry of 0.312W0.871 (r2=0.987), where W is body weight; predicted Vss (19.71 L) was similar to the reported value (20.10 L). However, CL prediction involved both simple and CF allometry. Best proximity CL (543 vs. 598 mL/min) was obtained with maximum life span correction (MLP) [2.46W1.215 (r2=0.988)]. Normalized curves were obtained by normalizing the time (with mean residence time) vs. concentration (with dose/Vss) in animal species. The concentration vs. time profile in humans after intravenous infusion was then simulated using normalized curve for each animal species and the values of CL and Vss were predicted for humans. In summary the findings indicate that normalized time course approach could predict the bendamustine human pharmacokinetics and such an approach could be prospectively applied for analog drugs of this class.

Induction and Impact of Anti-Drug Responses Elicited by a Human Recombinant Coagulation Factor FXaI16L in Preclinical Species

2019 ◽  
Vol 21 (3) ◽  
Author(s):  
Chuenlei Parng ◽  
Michael Bolt ◽  
Debra D. Pittman ◽  
Teresa Caiazzo ◽  
Lisa Dyleski ◽  
...  
Keyword(s):  
Coagulation Factor ◽  
Drug Responses ◽  
Preclinical Species

scholarly journals The Dog's Role in the Preclinical Assessment of QT Interval Prolongation

2003 ◽  
Vol 31 (1_suppl) ◽  
pp. 11-16 ◽  
Author(s):  
Michael R. Gralinski
Keyword(s):  
Cardiac Arrhythmias ◽  
Qt Interval ◽  
Safety Assessment ◽  
Safety Evaluation ◽  
Regulatory Agencies ◽  
Potential Drug ◽  
Interval Prolongation ◽  
Qt Interval Prolongation ◽  
Preclinical Species ◽  
Canine Models

During the development of a new therapeutic, few pharmacodyamic outcomes currently receive as much scrutiny as the effect of a potential medication on the electrocardiographic QT interval. The recent withdrawal from marketing of several drugs due to potential drug-related cardiac arrhythmias have greatly increased concern about drug-related changes on the QT interval. In order to reduce the incidence of these idiosyncratic episodes, regulatory agencies have suggested that sponsors use more rigorous methodology during the safety evaluation of new pharmaceuticals. Along with enhanced electrocardiographic assessments during clinical trials, advanced preclinical examinations of effect on QT interval and ventricular repolarization have become de rigueur. In this arena, the beagle dog is the preclinical species often associated with the most reliable predictivity for human safety assessment. To this end, canine models of cardiovascular safety assessment are discussed along with the relevance of these assays to human electrocardiography.

Prediction of Human Renal Clearance from Preclinical Species for a Diverse Set of Drugs That Exhibit Both Active Secretion and Net Reabsorption

2011 ◽  
Vol 39 (6) ◽  
pp. 1008-1013 ◽  
Author(s):  
Stuart W. Paine ◽  
Karelle Ménochet ◽  
Rebecca Denton ◽  
Dermot F. McGinnity ◽  
Robert J. Riley
Keyword(s):  
Renal Clearance ◽  
Active Secretion ◽  
Preclinical Species

scholarly journals Robust Translation of  -Secretase Modulator Pharmacology across Preclinical Species and Human Subjects

2016 ◽  
Vol 358 (1) ◽  
pp. 125-137 ◽  
Author(s):  
J. H. Toyn ◽  
K. M. Boy ◽  
J. Raybon ◽  
J. E. Meredith ◽  
A. S. Robertson ◽  
...  
Keyword(s):  
Human Subjects ◽  
Preclinical Species
Sign in / Sign up

Export Citation Format

Share Document