PharmPK Discussion List Archive - 2003

PharmPK Discussion List Frequently Discussed Topics

%ID/g radioactivity modeling
5 alpha-dihydroxytestosterone
6 beta hydroxylovastatin
A chemical without liver metabolism and bioaccumulation
A cross over study
A cross over study - Chest X-rays
Abamectin pharmacokinetics
About relative bioavailability
Absolute Bioavailability/Loratadine and Desloratadine
Absorption model considering solubility
Acceptance criteria for competitive radioimmunoassay
Accumulation and Fluctuation indexes
Accumulation index
Accuracy of current methods of predicting PK parameters
Active Metabolite Model
ADAPT II - info on data input structure
Age of mouse
Agitation with fluoroquinones
Amikacin once daily dosing
Aminoglycoside and cystic fibrosis
Amiodarone biostudy
Amodiaquine metabolites
Amount of Drug in Peripheral Compartment (3C Model)
Amphotericin PK/PD
An appropriate molecule for PK study
Analysis of captopril in human serum
Analysis of glimepiride in human serum
Analysis of ramipril in human serum
Analytical LC/MC question
Analytical method for Dipirone
Analytical question - phenol groups
Anatomy of small intestine in Rat
Anesthetised Rodent model of Asthma
Animal Model for glucuronidation studies
Animal models to study PK
Animal PK on Nafcillin, gentamycin, rifampin, clindamycin
ANOVA in WinNonLin
Antibiotics and the most relevant PK parameters
Antimicrobial Dosage
Application for essentially similar modified release form
Approved Prodrug products
Area of absorption
Aspirin by oral gavage
Aspirin PK and MEC
Assay Calibration
Assay validation
Atorvastatin PK
AUC and Cmax
AUC metabolite-drug
AUC, half-life & BE
AUC/MIC for concentration dependend antibiotic
AUC0-last and AUC0-inf
Autoinduction on chronic PO dosing
BA and BE guidelines comparison
BA studies for NDA
Basic Principles
Bayesian curve fitting
BBB models
BE / Statistical power
BE and Patients
BE and PK profile
BE inclusion criteria
BE requirement
BE Sample size
BE study design
BE Study requirements in Canada
BE Study with Combination Product
BE using Urine data
Beta Cyclodextrins
Bilirubin assay
Bilirubin LC-MS-MS assay
Bio waiver related doubts - Canada
Bio-analytics
Bioanalytical run acceptance criteria
Bioavailability calculation / AUC metabolite-drug
Bioequivalence
Bioequivalence based on Metabolite PK
Bioequivalence EU/FDA
Bioequivalence principles
Bioequivalence studies for oral contraceptives
Bioequivalence studies in animals
Bioequivalence trial with alendronate
Biological properties and physicochemical parameters
Biomarkers of drug induced nephrotoxicity
Bizoprolol
Blood flow to bone
Blood volume based on weight
Blood Volume in rats
Body weight correction?
Brain penetration
Brain perfusion
Brazilian PK Inspection
Caco-2 and bbb calculations
Caco-2 Quality Controls
Caco2 data
Calcium chloride PK
Calculating pk parameters for a rapidly cleared drug
Calculation of precision
Calculation of VRT
Calibration curve
Caloric intake in BE studies
Can we administer test drug in the form of powder in rodents
Captisol 20% as IV and PO vehicle in early PK study
Captisol 20% as IV and PO vehicle in early rat PK study
Carbon-14 studies in humans
Category of Inhibitor
Ceftazidime levels
Cimetidine metabolites
Cleaning databases
Clearance and absorption
Clinical development phases
Cmax after IV infusion
Cmax with an IV Infusion
Commercially available pharmacokinetic packages
Common Drugs
Compartmental Methods
Compartmental vs NCA
Concomitants used in anti-HIV therapy
Content of UGT expression in liver
Cremophor toxicity
CSF PK
Curve stripping algorithm
Cyclosporin measurement in blood
Cyclosporine assay
Cyclosporine fluorescence
CYP 2D6 Phenotype
CYP 3A4 activity in gut relative to liver
CYP 450 interactions
CYP inhibition
CYP2B6 selective inhibitor
CYP2C19 in vivo phenotyping assays
CYP2C19 metabolic rate
CYP3A4 and P-gp
CYP450
Cytoplasmic P-gp ?
Data management software
Database/List of P450 rates
Datasets for PK prediction software
Deconvolution with solution data
Degradation profile of nimesulide
Delayed release
Delayed release BE
Dermatological studies
Descarboethoxyloratadine
Determining pig plasma clarithromycin levels
Difference between PK cycles
Difference in systemic exposure between oral and IV route
Different half-life after oral administration
Digoxin PK in mice
Dimer=NCE?
Dissolution of an insoluble drug
Dissolution Profile
Dissolution profile Comparision
Dissolution Profiles
Dissolution test and parametric/non parametric test
Dissoulution of an insoluble drug
Distribution
Distribution in blood after iv dose in lab-animals
Distribution of PK data
DMSO
DMSO for IV administration
DMSO in IV formulation
Dog with bacteria Bordetella Bronchiseptica
Dose and Exposure Response Studies
Dose calculation of rabbits
Dose level to be considered in insitu absorption
Dosing IP with a suspension
Dosing phenytoin metabolites and analysis
Dosing solution verification
Double peak phenomenon after IV administration
Doxepin Metabolites
Drug absorption test
Drug interaction trial - cocktail approach
Drug Permeability
Drug permeability
Drug protein binding list
EC50 vs Dose
Effect of disease on anti-diabetic drug PK
Effect of the solvent volume of an induction drug
Effective half-life for accumulation
Enalapril Maleate
Enterohepatic circulation following multiple dosing
Enterohepatic recirculation in rat?
Enterohepatic recirculation in rats and mice
Epoxide Hydrolase assay
Esomeprazole pharmacokinetics
Estimating blood levels from plasma levels
Estimating std deviation for skewed data, small sample size
Estimating t1/2 in human using rat t1/2 data
Estimation of phenytoin clearance during hemodialysis
Estradiol bioassay
Experimental pharmacology listserv
External standard
Extrapolation in Bioequivalence studies
F equation with same dose and different subjects
F greater than 100%
FDA Lag Time Guidance
Fecal excretion and half-life
Female Himalayan rabbits
Fetal microsomes
Fill Solution
First pass hepatic simulation
Flip-Flop
Flip-flop kinetics
Flip-Flop Kinetics
Fluoxetine BE Study design
fMRI
Food effect BE studies
Formulating poorly water soluble NCE's
Formulation experimental design program
Formulations of Oxazolidinones
Forskolin solubility
Free pKa databases
Freezer stability-viability of cytosol and liver S9
GC-MS
Gender and bioequivalence
Generic peptide
Gentamicin PK
GI Transit time
Glimepiride in vitro biorelevant dissolution
Glimepiride Tablets: BE study
Glipizide Invitro Dissolution Medium
GLP guidelines for the conduct of Preclinical PK
Glucosamine Hydrochloride & sulphate
Glucosamine Hydrochloride assay
Glucose solution and oral administration
Glutathione
Glycaemic index and relative bioavailability
Glycofurol Safety Information - MTD in Human
Good dissolution and poor bioavailability
Goodness of fit - minimum objective function value versus -2LL
Greater activity after oral dosing
Guidelines for revalidation when changing biological matrix
Half life of oral and IV
Half-Life of Bicuculline
Half-life of Oritavancin in Man
Harmonic mean
Help on mouse anti-P-glycoprotein antibody
Hemolysis
Hepatic impairment and bile secretion
Hepatic re-circulation
Herbal Pharmacokinetics
High MW PEG animal and human PK
High plasma clearance
High volume of distribution
How best to use screening assays
HPLC method modification
Human and rat gut volume
Human Hepatocye Metabolism
Human skin for metabolism studies
ID outliers in BA studies
In vitro plasma t1/2 to CLp
In vivo antifungal activity
In vivo clearance from in vitro hepatocyte data
In-Vitro Dissolution Comparison Methods
In-vivo induction/inhibition info
Information about Extraction Procedures
Information on esterases
Information on PKPD assessment of anti-infectives
Injectable PEG
Insulin Polymerization
Interactant drugs for in vivo inhibition of renal organic and cation clearance
Interaction: vit.c vs phenytoin
Interindividual variability difference for explanation
Intra-subject CVs for Saquinavir
Intra-subject variability
Intraconazole solubilizers
Intratracheal administration in rat
Intratracheal administration of an inhaled steroid in pigs
Inulin assay
Inulin measurement
Invalid Assays
IP and First pass
Isoniazid PK in neonates
Isosorbide dinitrate bioequivalence study
IV dose and dosing schedule
IV dosing solvent
IV vs Oral Bioavailability Study
IVIVC
k vs beta,Vss
Kanamycin HPLC Assay
Ketoconazole
Ketoconazole - Cytochrome P-450 Inhibition
Ki In Vivo Determination & Other Desultory Thoughts
Lag time calculation in WNL
Lansoprazole assay
LC-MS-MS assay precision
Levosimendan
Lisinopril intra-subject CV
Liver carboxylesterase
Loading and Maintenance Dose
log P / D Databases
Looking for the acceptance range in BE test
Losartan active metabolite
Losartan metabolite
Low apparent volumen of distribution
Low concentration of drug in plasma
Low systemic exposure
MAO substrate scaling
Mass balance problem
Mass Spectrometry Guidance
Maximum concentration of Lecithin, SDS and Soyabean oil to Mice
Maximum dosage of PEG 400
Maximum IV dosage to rats
MDCK vs. Caco-2
Mean Plots
Mefenamic Acid Bioequivalence
Mefloquine ivivc
Meropenem drug monitoring in 3.5 mo infant
Metabolic stability of NCE's
Metabolism apparatus for stirred single cells
Metabolism of Glyburide and glypizide
Metabolite elucidation in tox species
Metabolite Inhibition (product inhibition)
Metabolite kinetics - peak formation vs molar formation fraction
Metformin
Methods to Estimate Drug Metabolism
Methotrexate TDM
Microdosing and HIV drug interactions
Midazolam
Missing data in bioequivalence studies
Missing dose times
Missing rodent tox data
Modeling flipflop in WinNonlin
Modeling query - Urine data without plasma data
Modelling & Simulation
Modelling of oral PK data with no absorption phase
Modelling query
Models for sustained/extended release
Monte Carlo Simulations
Mouse microsomal metabolic study
Multi dose bioequivalence study
Multi-exponential curve stripping in pharmacokinetics
Multiple blood sampling in mice
Multiple Cmax in PK Profile
n-calculation
NCA calculation
NCE solution formulation
Need invitro evaluation models for pharmacokinetics parameters
Need procedural advise on platelet activation and aggregation
Nephrotoxicity assays using human renal tissue
Neutral drug with low protein binding
Nictiazem or clentiazem
Nizatidine bioequivalence study
Non-specific binding of lipophilic drugs
Nonlinearity
Numerical difficulties with integration routine (IN NONMEM)
Omeprazole metabolites
Once daily aminoglycoside dosing
Oral dosing
Oral dosing to rats
Oral vs IV route
Outlier detection in Bioequivalence study
P-glycoprotein modulators in p'kinetic clinical trials
P-gp and BA
P-gp ATP binding sites
P450 inhibition and Duloxetine/Venlafaxine
Paclitaxel Sink conditions
Paracetamol metabolite
PBPK - What concentration is responsible for metabolism
PCB Metabolism
PEG400
Penetration of Drugs (antibacterials esp) Into Bone
Peptide metabolized by CYPs
Peptides Drugs and p450
Percent of ethanol used in iv administration
Permeability
Permeability calculation
Permeability of NCE's
Permeability studies
Permeation promoters
Pgp Substrates
pH gradient in SAM
pH in rat GI
pH of dosing solution
pH of IV infusion
Pharmacodynamic modeling of multiple drugs
Pharmacokinetic (Scientist)
Pharmacokinetic Information
Pharmacokinetics of Ambroxol
Phase III drug metabolism
Phase-II methylation
Phenytoin PK analysis
Physiological Parameters in Pigs
PK data sets
PK Flip-Flop
PK modelling philosophies
PK Models for sustained/extended release
Pk parameters in Children as compared to adults
PK parameters in subarachnoid space
PK parameters timolol in rats
PK PD Bioequivalence study
PK properties of substrate for pGP mediated efflux
PK studies in monkey
PK study of subcutaneous injection of parathyroid hormone in hairless rats
PK terms
PK-PD interactions
PK/PD relationship of MMF in lupus glomerulonephritis
pKa measurement (or computation)
Plasma assay for Simvastatin and Lovastatin
Plasma binding issues
Plasma conc and Cmax
Plasma concentrations of ketoconazole sufficient to inhibit intestinal PGP
Plasma Stabilisation
Plasma stability
Plasma vs. serum protein binding
Pluronics
PO limit of tween80 in rats
Polynomial regression
Poor oral bioavailability
Population pharmacokinetics references
Positive control in liver microsome studies
Post-partum creatinine clearance
Power of bioequivalence studies
Pre-clinical pharmacokinetic
Precipitation of plasma proteins
Preclinical Pharmacokinetics of Lovastatin
Prediction of maternal-fetal drug ratio
Prediction of plasma profile
Prediction of Steady-state parameters from single dose
Predictive value of in vitro methods-how to assess
Preparation of lymphocytes and PBMCs
Probability distribution of Tlag in MC simulation
Problems concerning bioequivalence studies
Prodrug AUC
Progesterone suppository
Protein assay result
Protein binding study
Protein renal clearance.
Question about clearance concept
Question on Dissolution of Drug
Question on trandermal patch
Quinolone pharmacodynamics
R & S warfarin enantiomers
Ramiprilat terminal elimination
Rat blood density
Rat Wistar with bacteria Bordetella Bronchiseptica
RBC uptake study
Reactive metabolites
Reference standard for Mometasone
References for pharmacokinetics for Omega 3 & 6
References for PKPD and M&S
Regarding blood volume sampling limits
Regarding Half life after oral and i.v. administration
Regarding insolubility and precipitation of compounds in Invitro study
Regarding Pharmacokinetic - pharmacologic interaction
Regarding pKa determination
Regarding sample size in preclinical PK
Regarding selection of time point for estimation of levels in CSF
Regarding study design
Related to drug absorption
Relative bioavailability
Renal clearance in monkeys
Renal excretion of cocaine in rats
Reporting bioavailability of prodrug
RIA and BE
Risperidone assay
Role of first pass effect in low dose aspirin
Salt Selection & Pre-formulation issues
Sample collection from brain?
Sample retention
Sample size calculation for BA/BE studies
Sample Size for Williams Designs
Sample size in BE
SAS PK Macros
Scientist model
Search for commercial oxodipine
Second humps in Oral profiles
Sequence and replicate design
Sequence effect
Sertraline Reference Standard
Serum or Plasma?
Serum Stability
Simply describing AUC, Cmax and/or Tmax!
Simulation and total AUC with winnonlin
Simultaneous fitting of plasma and urine data
Simvastatin Dissolution.
Skin homogenization method
Sodium sulfite for IV-IM injection
Software for Characterizing correlations between physiological parameters
Software validation
Solubilisation of Oxazolidinone compounds
Source for obtaining Mivacurium isomers
Source of 7-OH-methotrexate
Species differences
Species differences w.r.t. non P450 clearance
Specification-setting statistical methodology
Spectrophotometric (UV-visible) method of estimation
Stability in plasma/serum
Stability studies
Statistical Analysis for Repeated Dosing
Statistical method for mouse studies
Statistical methods for the Analysis Of Assays
Statistical terms
Statistical test for comparision
Statistical test for dose proportionality
Statistical test for Tmax
Stomach volume in rat and mouse
Study of liver microsomal enzyme 1 A activity
Study requirements in Canada
Study with Combination Product
Subacute toxicity
Sugar level in diabetes
Sum squared errors
Superpositioning: How far to predict missing points
Surrogate for Aqueous Humor
Tacrolimus in cerebrospinal liquid
Taxol LOD
Taxol solubility
Taxol stability
TDM of antiepileptic drugs during renal dialysis
Tests of Normality
Text on drug development
Therapeutic Range
Time for BE approval and Study duration
Time of peak
Tissue blood amount
Tissue Concentration
Tissue Distribution Analysis: perfuse tissues?
Tissue distribution in spleen
Tissue sample prep
Tlag
Tolbutamide bioavailability
Topotecan and Iressa
Tox/Metabolite databases and predictive software
Toxicity of a single high gentamicin dose
Toxicological tests
TPMT activity
Training-Metabolite profiling
Transdermal absorption in children
Transport studies on Atovaquone
Transporter involved in intestinal absorption
Trilostane metabolism in canine
Truncated AUCs
Unbound fraction calculation
Unit conversion for Jmax (P-gp efflux)
Update on P3M Software
Uptake study
Urinary data curve fitting
Urinary pH - Monkeys
Use of 10% DMF?
Use of ether
USP Antimicrobial Effectiveness Test
Vaginal Metabolism
Valproate levels
Values below LLOQ
Values below LOQ
Values of Aqueous solubility, logP and logD
Vascular Cannulation for Rat PK
Vehicle for i.v. adminstration of water-insoluble compound
Vehicle for IV PO PK in mice
Vehicle for SC PK in mice
Vehicle/solvent for invitro assays
Vehicles for in vivo administration
Vehicles for toxicokinetics
Verapamil-Oral dose as P-gp inhibitor to Wistar rats
Very High Clearance Compounds
Veterinary bioequivalence studies
Vigabatrin PK
Volume of Distribution
Volume of Distribution of Enalapril
Volume of dose for in vivo administration
Vss
Vss in Pregnant rats
Wagner-Nelson equation in WinNonlin
Waiver in Bioequivalence
Ways to measure renal clearance
Weak acid/base
Weighted calibration curves
When Bioequivqlence Study require?
When is PK not needed
Whole rat homogenization
WinNonLin - physiological pharmacokinetic model
Winnonlin 1.5 version Compartmental Modeling
WinNonlin Model
WinNonlin modeling
WinNonlin modeling and Double-Peak Curve
WinNonlin models
WinNonlin NCA model 202 and time of last dose
WinNonlin User Models
WinNonlin User Models - three compartment model
WNL alternative model problem
World Conference on Dosing of Antiinfectives
XML language representation of PK Data
Zafirlukast fluorescence

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