Personalization of pharmacotherapy with sirolimus based on volumetric absorptive microsampling (VAMS) in pediatric renal transplant recipients-from LC-MS/MS method validation to clinical application. [PDF]
Kocur A +7 more
europepmc +1 more source
This study explores the feasibility of expressing the antitumoral protein Amblyomin‐X through a suicide gene therapy approach and investigates its intracellular fate after gene delivery. Although the gene is efficiently expressed, melanoma cells rapidly degrade the Amblyomin‐X protein via proteasome activity.
Victor Dal Posolo Cinel +4 more
wiley +1 more source
A high-performance liquid chromatography method validation and a Box-Behnken experimental design for the extraction optimization of quercitrin from Nectandra reticulata. [PDF]
Pulido Teuta J +2 more
europepmc +1 more source
Advancing Bioanalytical Method Validation: A Comprehensive ICH M10 Approach for Validating LC-MS/MS to Quantify Fluoxetine in Human Plasma and Its Application in Pharmacokinetic Studies. [PDF]
El Orche A +9 more
europepmc +1 more source
Use of logit transformation within statistical analyses of experimental results obtained as proportions: example of method validation experiments and EQA in flow cytometry. [PDF]
Seiffert S, Weber S, Sack U, Keller T.
europepmc +1 more source
HSPiP, Computational Modeling, and QbD-Assisted Optimized Method Validation of 5-Fluorouracil for Transdermal Products. [PDF]
Hussain A +5 more
europepmc +1 more source
Use of Uncertainty Calculation Software as a Didactic Tool to Improve the Knowledge of Chemistry Students in Analytical Method Validation. [PDF]
Cerrato-Alvarez M +2 more
europepmc +1 more source
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Validation of Bioanalytical Methods
Pharmaceutical Research, 1991Validation of bioanalytical methods used to generate data for pharmacokinetic and bioavailability studies is approached by a variety of techniques and is subject to many different methods of interpretation. This Review puts the various techniques into perspective and discusses pitfalls which may occur in interpretation of validation data.
H T, Karnes, G, Shiu, V P, Shah
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Reliable analytical data are a prerequisite for correct interpretation of toxicological findings in the evaluation of scientific studies, as well as in daily routine work. Unreliable analytical data might not only be contested in court, but could also lead to unjustified legal consequences for the defendant or to wrong treatment of the patient ...
Frank T, Peters +2 more
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This paper gives a review of cross-validation methods. The original applications in multiple linear regression are considered first. It is shown how predictive accuracy depends on sample size and the number of predictor variables. Both two-sample and single-sample cross-validation indices are investigated. The application of cross-validation methods to
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