In the pharmaceutical and biotechnology industry, analytical method transfer is a critical step in drug development that is typically encountered by biotech and pharma R&D personnel. Broadly, it is a documentation process that enables one laboratory (receiving laboratory) to set up and utilize an analytical test procedure that originated in another laboratory (sending laboratory). Method transfer ensures that the receiving lab has all pertinent method details, such as sample preparation approach, favorable equipment settings, and desired atmospheric conditions to reproduce the analytical test procedure systematically. Method transfer is a critical step in drug development that’s quite frequently encountered by biotech and pharma R&D personnel. Method transfer ensures that the receiving lab has all pertinent method details, such as sample preparation approach, favorable equipment settings, and desired atmospheric conditions to reproduce the analytical test procedure systematically.
Analytical method transfer is a critical step in drug development that’s quite frequently encountered by biotech and pharma R&D personnel. Broadly, it is a documentation process that enables one laboratory (receiving laboratory) to set up and utilize an analytical test procedure that originated in another laboratory (sending laboratory). Method transfer ensures that the receiving lab has all pertinent method details, such as sample preparation approach, favorable equipment settings, and desired atmospheric conditions to reproduce the analytical test procedure systematically.
Nonclinical toxicokinetic studies (tox) 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.
Toxicokinetic (TK) studies are useful for determining time course of absorption and distribution of a drug, metabolite(s), or prodrug(s), both in vitro and in vivo. Time courses of drug concentrations in blood, urine or saliva can be determined by appropriate sample collection methodologies. A TK study may be conducted after animal dosing with an oral dose of a drug substance, or when the study includes several doses.
Toxicokinetics studies are vital to drug development. Toxicokinetic (TK) studies help quantitate the systemic exposure time course for prodrugs, drugs, and metabolites. We understand how critical these studies are for ensuring safe and efficacious drug candidates, and our experienced team conducts GLP regulated TK 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.
We work closely with regulatory agencies, including the US FDA, to design and implement nonclinical toxicology studies that help successfully address safety concerns and efficiently advance in the drug development process. Our experience includes GLP toxicokinetic-pharmacodynamic (TK-PD) studies, nonlinear mixed effects modelling (NLMEM), in vitro assessment of toxicity/safety, and 5-Aminolevulinic acid (5-ALA) photodynamic therapy (PDT)-induced skin reactions.
