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Design of metabolites in safety testing (MIST) studies and strategies.PK and PK/PD calculations (WinNonlin), modeling and simulation, and reporting.Performance of interim reports of blinded data and participate in regular safety committee meetings in dose escalation studies.Design of FIH studies with adaptive design and dose setting.Support, participation and preparation of data for meetings with regulatory authorities.Summarize non-clinical and clinical PK sections in the IMPD and IB documentation.Predictions of human PK (in vivo-in vitro extrapolation, allometry and physiological based-pharmacokinetics).Non-clinical support of clinical trial-enabling studies with focus on PK, PK/PD, TK, drug metabolism, drug-drug interaction (DDI) and bioanalysis.The clinical Pharmacologist provides pharmacokinetic (PK) and pharmacodynamic (PD) services ranging from integration of early development PK/PD data to design of the first-in-human (FIH) studies to proof-of-concept trials. Integrated non-clinical support available together with CTC’s sister companies Toxicology Knowledge Team, Lablytica and RegSmart.Experiences with small molecules, peptides, therapeutic proteins, ATMPs, oligonucleotides and radiopharmaceuticals.Support regarding scientific publication, scientific advice meetings and due diligence assessments.
#Winnonlin modeling software#
Users of software other than WinNonlin will also benefit from the methods. Prediction of human PK and human efficacious doses with help of in vivo-in vitro extrapolation, allometry and physiological based-pharmacokinetics (PBPK) Give delegates the unique opportunity of access to the WinNonlin modeling.Project support of clinical trial-enabling studies with focus on PK, PK/PD, TK, drug metabolism, drug-drug interaction (DDI) and bioanalysis.Design and interpretation (PKPD) of non-clinical pharmacology studies.Design, calculation (WinNonlin) and reporting of non-clinical PK and toxicokinetic (TK) studies.Strategic project support regarding compound optimization in drug discovery with focus on DMPK and pharmacokinetics & pharmacodynamics (PK/PD) Phoenix® WinNonlin® NCA will use the following settings to compute parameters from plasma PK data: Linear Up Log Down calculation method Uniform weighting Extravascular dose Plasma Model Type Lambda Z Acceptance Criteria o Rsqadjusted 0.Models were initially executed in PCNonlin or WinNonlin and automated.
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#Winnonlin modeling trial#
The non-clinical Drug Metabolism and Pharmacokinetic (DMPK) consultant provides services ranging from compound optimization and selection to First-In-Human (FIH) clinical trial application. For each model, both software packages were presented with identical implementations.
#Winnonlin modeling full#
The full results of the comparison and the model files in SAAM II and PCNonlin/WinNonlin formats are available from the authors.Our senior advisors offers in-house services ranging from compound optimization to proof-of-concept trials, with focus on DMPK and PK/PD. Additionally, there were differences when multiple data sets were fitted, indicating the importance of different fitting procedures for interpreting multiple kinetic data sets. However, due to differences in the optimization procedure, parameter standard errors showed considerable differences. In general, there was good agreement (<1% difference) between SAAM II and PCNonlin in terms of parameter estimates and model predictions. Observed differences, mainly in parameter standard errors, can be accounted for in terms of different optimization algorithms, convergence criteria, and individual capabilities. Parameter estimates, their precision (standard errors), and model predictions were compared a difference of 1% or less was considered "agreement". The total number of attempted comparisons between SAAM II and PCNonlin was 161, of which 142 executed without problems. We compared 88 different models, many of them in different configurations, e.g., different weighting schemes or different parameter limits. Maximum number of compartments, data sets, and parameters were 9, 5, and 10, respectively.
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Models investigated included one- and multicompartment models with nonlinearities, multiple inputs and samples, multiple simultaneous experiments, and linear equations. Models were initially executed in PCNonlin or WinNonlin and automated comparisons with SAAM II made using Microsoft Test. For each model, both software packages were presented with identical implementations. This paper presents a detailed comparison of the kinetic analysis software packages SAAM II and PCNonlin/WinNonlin, based on benchmark modeling problems reported in "Pharmacokinetic andPharmacodynamic Data Analysis: Concepts and Applications" (Gabrielsson and Weiner, 1994) and seven additional models.