PharmPK Discussion List Archive - 2009

• 3-period-3-sequence replicate design in scaled average BE
• A list of US-Registered Pulse Release Products
• A question of clearance
• Absorption factor Paclitaxel and 6HydroxyPaclitaxel
• Absorption rate constant by deconvolution
• Acceptability of adduct for the assay of a compound
• Acceptability of compound with loss of water molecule
• Access to data of published work
• Accuracy and precision, Stability
• Acetaminophen biowaiver
• Acetonitrile Precipitation and Protein-binding
• Active-mediated drug efflux
• Activity-MC suspension vs HPMC suspension
• Addition of fragment ions for quantitation
• Adefovir stability
• Adjusting the dosing of medication in pregnancy
• ADME studies in different stages of drug discovery-development
• Allometric exponents
• Analysis of Amodiaquine
• Analysis of highly protein bound drug
• Analysis of log transformed data
• Analytical method-lab for DFMO and Nifurtimox determination
• Analytical methods used in Pharmacokinetics
• Animal model for rectal dosing
• Animal sample size and ethical clearence
• Anomalous concentration decision tree
• Anticancer drug BE studies in healthy volunteers
• Antipyrine IV formulation
• Applying K-PD model to botanic drugs
• Approach to handle Outlier Data
• Archiving electronic data
• Aspirin and Salicylic acid
• Aspirin Cmax
• Assignment of conc value to BLQ in middle of profile for AUC calculation
• ATPase assay
• AUC after infusion administration
• AUC from multiple dosing in WinNonlin
• AUC t-infinity more than 10%
• AUCinf
• Average Molecular Weight vs Monoisotopic Molecular weight
• Avian PK data and modelling
• BA calculations using SAS
• Balaam design in replicated BE studies
• BalbC body weight loss
• Baseline correction
• BCS classification of Darifenacin HBr
• BCS Classification of drugs
• BE based on urine excretion data
• BE study dose
• Bell shape pharmacokinetics
• Betahistine PK
• Biliary Elimination and % dose excreted
• Bioanalytical method for alfacalcidol and paricalcitol
• Bioanalytical method validation for FDC
• Bioanalytical sample size
• Biocompatibility Evaluation
• Bioequivalence CI
• Bioequivalence of itraconazole
• Bioequivalence of IV Solution Formulations
• Bioequivalence of orlistat
• Bioequivalence Study For Diazepam Rectal Solution
• Biokinetics of a metabolite
• Biomarkers and PK
• Biosimilars
• Biowaiver for solution
• Biowaiver of Borderline class I drug
• Blood versus plasma
• Breast cancer resistance protein
• Buffer for metabolic stability experiment
• Bufuralol lc-ms method
• Caco Assay using BD Biocoat HTS Caco-2 Assay System
• Caco-2 experiments
• Caco2 permeability
• Calculate AUC, Cmax and Tmax in SAS
• Calculating MAT Parameter Without MRTiv Data
• Calculation of percentage absorption
• Calibrator QC query
• Can soft-ionization produce radical
• Carbonyl reductase source
• Carry over problem
• CFR part 11 compliance
• Chitosan Nanoparticles
• Chronic Kidney disease and Drug dosing
• Chronopharmacokinetics study
• Circadian rhythm and chronopharmacokinetics
• Classification for protein binding results
• Clearance and Distribution Volume Calculations at Steady-state
• Clinical relevance of DDI
• Closed Loop Model
• Clozapine as a probe drug for CYP1A2
• CNS efflux
• Comparative pharmacodynamics
• Compartmental Modeling Using WinNonlin
• Compartmental pharmacokinetics
• Components of NADPH regenerating system
• Concentration of mechanism-based inhibitor
• Consultant need - software validation
• Contamination of HPLC system with drug
• Conversion of drug to metabolite
• Correlation between dose and clearance
• Correlation of paddle speed and peristaltic movement
• Creatinine clearance
• CRO Bioanalytical Labs and traits
• Cross-over design WinNonlin
• CV hidroxizine
• CYP 2C8 Mediated Metabolism of Rosiglitazone
• CYP1A2 inducers - EC50 evaluation
• CYP450 concentration
• Data Aggregation Positions in Pharmacometrics at GSK
• Deconvolution prior to IVIVC
• Decreased exposure in TK study
• Definition of Dose multiple
• Derivatization in mass spectroscopy
• Desacetyl rifampin
• Desmethyldiazepam
• Detection of aromatic amines in PFA-fixed tissue or cells
• Difference between the NADP and NADPH
• Difference in CYP3A activity using the different vehicle
• Different bioanalytical methods for Fasting and Fed study
• Different result of pharmacokinetics parameter in rabbit
• Different results with using MDV and not using MDV
• Differentiating formulations by dissolution
• Dilute plasma protein binding
• Dissolution and dosing rabbits with tablets
• Dissolution method development for microspheres
• Division of AA&R products and first in human studies
• Documentation of NCA
• Donepezil enantiomers
• Dose calculation
• Dose optimization
• Drug excretion
• Drug input sigmoidal
• Drug Metabolism Scientist
• Drug release rate calculation
• Drug uptake in cell culture
• Effect of poloxamer on the invivo release
• Efflux transporter
• EMEA guidlines on Modified release oral dosage forms
• Enteric coated capsules in monkeys
• Enteric-coated capsule for rat dose
• Establishment of steady state conditions
• Etoposide bioanalytical assay
• Evaluating intersubject variability
• Excel spreadsheet add-in for MRT
• Excel validation
• Experience with HepaRG cells
• Experiment design for immunosuppressive drug
• Extended Release Matrix versus Multiparticulate Formulations for Once-Daily Dosing
• Extraction from plasma
• Extraction of Azacytidine
• Extraction ratio
• First in human dosing
• Formulation-dependent time-variant PK
• Four period replicate reference scaling bioequivalance
• Four treatment study design for Bioequivalence
• Free fractions in plasma
• Free Interactive Complete PBPK Software
• Generic biological product
• Generic tablet same in color and shape to innovator
• GFR * Fu = the upper limit of renal CL for passive filtration, a myth or truth
• GI Transit times in rats and mice
• Grade or viscosity of HPMC
• Gradient method
• Groups in BE Studies
• GST and UGTs in Rat liver
• Half-life greater than 48 hours
• Help with PD data
• Hepatic extraction ratio for glyburide glibenclamide
• Hepatocyte cultures
• Hepatocyte sandwich culture
• Hepatocytes or Microsomes with added protein
• High or low hepatic clearance drugs
• High-end triple quadrupole mass spectrometer
• Highly variable drugs
• How to choose recombinant CYP450 Enzymes
• How to choose the concentration of chemical inhibitor for CYP
• How to express AUEC in terms of AUC
• How to face and successfully defend FDA audits/inspections
• How to install G77 fortran compiler to run Adapt 5
• How to make experiment in PKPD
• HPLC column cleaning
• Human intestinal water reabsorption rate constant
• Hydrophilic partition coefficient determination
• ICP-MS
• In vitro and in vivo
• In-vitro and in-vivo Hydrodynamic condition
• Increase of solubility of one drug in presence of other drugs
• Increased volume of distribution with age
• Increasing plasma levels in iv pk study
• Incurred sample reanalysis
• Incurred Sample Reanalysis and Haemolysis
• Infusion stopped at 24 hrs
• Infusion Studies In Mice
• Inhalation dose versus oral dose
• Inhibition mechanism of ketoconazole
• Initial PK studies in rats
• Insect CYPs
• Interaction potential limited by bioavailability or extent of metabolism
• Interferance in LCMSMS method
• Interlaboratory comparison TB drugs
• Interspeciesinfo website update
• Intersubject Variability
• Intestinal extraction model in rat.
• Intestinal metabolism - Intrinsic clearance
• Inverse relationship dose-concentration
• Ion exchange cartridge problems
• Ion suppression
• IP DMSO in mouse
• Isolation of hepatocytes
• Itraconazole formulation DPDM
• IV bolus+IV infusion PK with WinNonlin NCA
• IV dosing of insoluble compound
• IV formulation problems
• Jobs in PK
• Ki for Ketamine
• Korsemeyer peppas constant
• Laplace transform derivation of infusion equation
• LBA Method Validation
• LBA Standard curve
• Linear vs Log Trapezoidal Rule for AUC
• Liposmes and nanoparticles
• Liposomes bioequivalence
• Liver Physiology Reference
• Log transform urine data
• Magnesium chloride concentration
• Marketing status and regulatory submission
• Mass spec instrument choice
• MDCK cell lines
• Metabolic stability experimental protocol
• Metabolite volume of distribution
• Method validation
• Mice dosing formulation
• Microsomal t1/2 of Verapamil and Piroxicam
• Midazolam as in vivo glucuronidation probe
• Minimum concentration for LC-NMR
• Minocycline bone concentration
• Mobile phase additive
• Model for Cumulative Excretion in Bile
• Modeling transduction cascades
• Monkey anesthesia
• Monoclonal antibody absorption
• Multimedia Dissolution Matching EU
• Multiple dose code in WinNonlin user model
• Multiple dosing in WNL
• Multiple dosing Simulations in SAS using Proc Model
• Multiple gelatin capsules
• Multiple peak in plasma levels after oral administration
• Multiple PK data analysis
• Nanoparticle circulation time in body
• Nevirapine trough concentrations
• New online Journal - Journal of Pharmaceutical Sciences and Research
• New version of the MM-USCPACK software
• New version of the pdx-mc-pem program
• NMTRAN error
• Non-Linear pharmacokinetics
• Non-specific inhibitors for CYP and UGT in rats
• Non-specific protein binding
• Nonlinear standard curve
• Not getting reproducible results with GCMS
• Omitting points on calibration curve
• One test two reference products
• Oral cancer drug development resources
• Oral formulation made in DM water
• Oral PK Profile of NCE similar to sustained release product for 5 day
• Outlier detection in Bioequivalence Study
• Outlier Subjects
• Oxidizers
• P-gp substrate confirmation
• Para-O-sulphate rosiglitazone in human DDI study
• Partial validation
• Passage Number Effects In Caco-2 Cell Line
• Peculiar PK in first-into-man study
• Pediatric dose calculations
• PEG 600 and PVP K-30 for Inhalation route
• PEG for oral administration in rats
• PEG-200
• PEG300 versus PEG400
• Penicillin G Procaine Activity vs Purity
• Performance verification of column
• Permeability and phosphate buffer ion suppression
• pH Solubility problem
• Pharmacokinetics of nanoparticulate vaccine systems
• Pharmasolve in oral formulations
• PK data sets
• PK exposure of different salts
• PK of Biotech Derived Biotech Drugs In Renal Impairment or Elderly
• PK of clopidogrel
• PK of IV simvastatin
• PK of oral nanoparticles
• PK parameters for extended release morphine
• PK-PD correlation for anti-asthmatic drug
• PK-PD PopPK studies
• PKPD experiment in relation with circadian rhythm
• Plasma protein binding of Olanzapine in rats and guinea pigs
• PLT Tools: A Graphical Interface for the NONMEM System
• Point to point correlation
• Positive control for esterase assay
• Pravastatin analysis
• Pre-clin body weight correction
• Prediction of human PK from animal data for pegylated proteins
• Prediction of steady state concentration
• Predose conc above 5% of Cmax yet less than LOQ
• Preparation of 'inf' and 'dat' for Submissions in the CTD for Health Canada
• Preparation of 'inf' and 'dat' for Submissions in the CTD for Health Canada
• Prodrug bioequivalence waiver
• Prodrug ivivc
• Programming with S-ADAPT
• Proposal to built an interface for SADAPT
• Prostacyclin and thromboxane synthases and 1-aminobenzotriazole
• Protein binding assay method
• Protein binding by equilibrium dialysis
• Protein binding of macromolecular drugs
• Protein precipitation
• QA-QC for ELISA TDM of immunosuppressants
• QD dosing regimen
• Quant/Qual LC/MS
• Question on intestinal muscle exposure
• Questions on Oxidizers
• Quoting package insert
• Rat intestine surface area
• Rate of infusion using WinNonlin 5.2
• Rate-limiting step for absorption
• Reactive Metabolite
• Recombination humanized cytokine assay
• Reductases in microsomes
• Reference on the number of NDAs
• Reference scaled design
• Reference Scaling Average Bioequivalence Approach (RSABE)
• Remove hemolysis
• Renal secretion
• Reporting means and use of statistics
• Retention of study drug samples in therapeutic trials
• Ridiculously high clearance
• Rifapentine analytical reference standard
• Rinsing the tip
• Risedronate bioanalysis
• Risedronate bioequivalence
• RLD selection
• Salicylic acid assay using trinder method
• Sample design
• Sample size
• Secondary parameters for 3 compartment model with first order absorption
• Selectivity in presence of concomitant medication
• Sertindole BCS
• Shift in Tmax
• Shift of Adduct Formation
• Single Pass Intestinal Perfusion
• Single point microsomal stability assay
• Skin hydrating agents
• Small Airway Epithelial Cells
• Solvents used in caco2 permeability studies
• SOPs for Pharmacokinetic Re-assays (Bioequivalence studies)
• Source for blood
• Source for superoxide dismutase
• Source of mouse P450s
• Species Differences in plasma stability
• Stability studies fails at 40/75
• Stability Validation
• Standard errors of Bayesian parameter estimates
• Standard placement during analytical runs
• Statistics design for bioequivalence studies
• Stratification for renal impairment
• Study design
• Subcutaneous injection volume
• Sublingual administration
• Suppression effect
• SURVEY: Consolidated CRO
• Suspended hepatocyte experiment
• Switchability in BE 4 way replicate cross over study
• Tablet in tablet formulation
• Target Dissolution Rate for Extended Release Dosage Forms
• Testing for gender effect in non-BE studies
• Thinking about guidelines
• THU - deaminase inhibitor - blood collection tubes
• Time points in pk profile
• Tissue homogeniser-pulveriser for distribution studies
• Tissue transport in pbpk models
• Transdermal Delivery
• Transdermal patch adhesive
• Transport buffer in transport studies
• Two compartment AUC
• Two one way test and usual asymetric test using SAS
• Urea measurement on hepatocytes
• US FDA approval based on BE study with EU reference product
• Use of in-vitro metabolism data
• Using Tmax as primary endpoint
• Vancomycin dosing in critical patients with a failing renal function
• Vancomycin TDM and administration
• Variation in clearance within a population
• Variation in IS
• Variation in study drug concentration
• Very abnormal high Cmax from rat PO
• Very short half life drug with good PD
• Weblinks for SmPC and PIL
• Weibull absorption models
• Well stirred model and free fraction
• WinNonlin
• WinNonlin 5.2 and Phoenix 6.0 comparison
• Winnonlin 5.2 not saving files
• WinNonlin and Phoenix comparison
• WinNonlin bioequivalence Wizard
• WinNonlin Error 10150
• WinNonlin for two weeks toxicology study
• WinNonlin Model for Data in Peripheral and Central Compartment
• WinNonlin steady state PK data
• WinNonlin Validation
• Working standard
• Writing differential equations (mass or concentration)
• Yellowish green colored plasma
• Ziprasidone Log P

Copyright 1995-2010 David W. A. Bourne (david@boomer.org)