PharmPK Discussion List Archive - 2005

PharmPK Discussion List Frequently Discussed Topics

21CFR11 for freelancers
4x4 Crossover BE
About missing data in population PK modeling
Absolute bioavailability
ACCP - Student Outreach Initiative
Additive model and Multiplicative model
ADME in homo- vs. heterozygote mice
Adverse event-Blood pressure
Advice on internal standard retention times
Age/weight effects on CYP2D6 activity
Albumin binding sites
Allometric scaling
Allometry Book
Aminoglycoside target concentrations
Aminopeptidase Inhibitor
Amlodipine analysis
Analysis of clonidine in plasma
Analysis of drug in bile
Analysis of ramipril in human serum
Analytical method for Rabeprazole + Domperidone
Anesthesia-induced pharmacokinetic changes
Anomalous Pharmacokinetics of Amiodarone
Antibiotic administration to patients on Dialysis
ANVISA accreditation
Assay carry-over
Assay extraction problem
Assay question
Assay Randomization for BA/BE
Assessment of linearity
ASTM procedures on equilibirium dialysis
Atorvastatin Pharmacokinetics
AUC debate
AUC inf Vs Auc all
AUC questions
AUC0-t calculation
Automatic blood sampler system
Autosampler qualification for LC-MS/MS applications
b-Cyclodextrin formulation
BA and BE study
Bactrim Skin Penetration
BCS classification
BCS classification Ampicillin and coxacillin
BCS prediction
BE and strengths
BE and Trimebutine
BE calculations using WinNonlin
BE for aerosols
BE for anally applied topical product
BE Metabolites assessment
BE of topical drug products
BE outlier question
BE study design acceptability
BE study for extended release: tablets vs capsules
BE study of antiretroviral drugs in healthy volunteers
BE submission guidelines for Australian submission
BE with non RLD strength for SR formulation
Benzylpenicillin procaine pharmacokinetics
Biliary clearance calculations from liver perfusion studies
Biliary elimination
Biliary index
Bioanalysis
Bioanalytical method for rosiglitazone maleate
Bioanalytical quantification
Bioanalytical validation
Bioavailability of compounds under screening
Bioavailability study with enteric coated tablets in animals
Bioavailibility of a compound with nonlinear clearance
Biodisponibility
Bioequivalence
Bioequivalence and bioavailability
Bioequivalence CI
Bioequivalence criteria
Bioequivalence for IV
Bioequivalence for two actives dosage form
Bioequivalence query
Bioequivalence Studies
Bioequivalence studies on Oncology drugs
Bioequivalence study for Oral suspension
Bioequivalence study of anicancer drugs in animal
Biorelevant media and extraction
Biorelevant media fed condition
Biowaiver ibuprofen
Biphasic Pharmacokinetic
Blood clearance exceeds blood flow rate
Blood collection in BE
Blood sampling
Blood vessel distribution in human and rat skin
Brain perfusion systems
Caco-2
CACO-2 doubling time
Calculating a Papp from a mesenteric Loop Study
Calculating AUC for Tobramycin in CF Patients
Calculating F from multiple datasets
Calculating Tmax/Cmax
Calculation of half-life
Calculation of loading and maintenance dose
Calculation of Single and mutiple dose volume of distribution
Calibration and Extrapolation
Calibration curve
Calibration Curve Approval
Captisol for inhalation delivery
Carisoprodol BE
Carvedilol and HPLC
Cassette Dosing
Cellulose acetate filters filtration
Change of Active Substance During Development
Chlorhexidine assay
Chondroitin sulphate plasma assay
Chromosomal Abberation Assay
Circulating metabolite
Citalopram PK
Clearance and Volume of distribution
Clearance calculation-iv bolus or infusion
Clinical DDI study designs
Cmax/tmax with no interpolation
CMC formulation
Co-delivery of protein and small molecules
Coefficient of Variation
Combitool
Commercial Source for Human Liver Microsomes: Specifically Chinese
Comparison of two plasma-concentration curves from pk study on mice
Compliance question
Compound precipitation in vivo
Concentration in tissue
Confidence interval
Corn oil/DMSO formulation for oral studies
Correlation between cLogP and LogP
Cremophor EL toxicity
Cut off Values: Clearance and Bioavailability
CV%rez greater than 30%
Cyclodextrin and Sterility testing
Cyclosporine measurment in blood
CYP450 interactions and hepatic extraction ratio
Data set for PK software
Data Simulation
Deconvolution using WinNonlin
Definition of bolus dose
Delayed Tmax after IV Bolus of Monoclonal Antibodies to Rabbits
Determination of topiramate
Determining P-gp substrate
Dextran in 09%NaCl
Differences in PK between rodents and monkeys
Different values for metabolite AUC
Difficulty with FOCE
Diffusion models
Dissolution database
Dissolution of an insoluble drug
Dissolution profile limits
Dissolution profile similarity in three media
Dissolution test suppository
DMSO concentration tolerated dose
DMSO in PAMPA
DMSO vs DMA
Do we need to completely solubilize
Dose calculation
Dose Similar Formulations
Drinking water in BE study
Drug Assay Instrument
Drug binding in the tissue
Drug binding to erythrocytes
Drug Concentration decline during IV infusion
Drug distribution
Drug dosing with water
Drug effect equation
Drug erythrocyte/plasma ratio
Drug Interaction Studies
Drug interactions
Drug stability in biological fluid
Drug stability in solution
Drug-drug Interaction
Drug-serum albumin interaction
DSMO in permeability experiments
EC90
EC90 propranolol
Effect compartment models with differing 'on/off' rates?
Effect of formulation on Vdss
Effect of low temperature on gastric emptying of water
Effect of Tween 80 on Pgp
Effect of water volume on drug absorption
Effects of Dose Site(s) and Dose Concentration on Subcutaneous (SC) Bioavailability (BA) in Man
Elemental composition of man and animals
Elimination constant of methylprednisolone prednisone and prednisolone
Elisa kit for risedronate
End of semester MCQ and short answer question
Enoxaprin pharmacokinetics
Enterohepatic circulation
Enterohepatic recirculation of NCEs
Enzyme assay
EPA's models
Equilibrium dialysis
Errors and Omission Insurance
Ethnic differences
Ethnic differences in PK and metabolism
Examples of unrelated pharmacokinetics and pharmacodynamics
Extraction method
Fasted Dosing
FDA and modeling software
Fed Meal Plan - Reg
Felodipine assay
Female subjects in BE studies
Femoxetine solubility data
Final Guideline on estimating safe starting dose
First Point Cmax
First-pass PK
Fluoresence test for Hydrotrope
Formula for calculating Intrasubject CV
Formulation of poorly soluble compounds
Fosinopril metabolism
Fractal Kinetics
Fraction of drug absorbed from oral dose of domperidone
Ganciclovir BCS class
Gelling of Serum
Gender-Dependent PK
Gene expression studies during a PK profile
GFR in rat and dog
GI fluid volume
GI residence time
GI transition time
Glimepiride Tablets: BE study
Glomerular filtration rate in the mouse
Glomerular filtration rate MW cut off
GLP necessity for preclinical studies
Glucuronidation
Gly-Sar physicochemcial properties
Goodness of fit statistics
Greater availability with nasal sprays compared with IV
Greater availability with SC compared with IV
Group effect
Guidelines for conducting pre-clinical in-vivo PK studies
Half-life calculations
Health Canada guidance query
Hepatic and renal enzymes
Hepatic cytosol protein content in different species
Herbal - drug interaction
How to calculate tissue:blood partition coefficient by AUC?
How to construct a dissolution profile of a drug
How to dose rat compare to human
How to model enterohepatic recirculation
HPLC assay for Arteether
HPLC Assay problem
HPLC assay with fermentation broth matrix
HPLC based method of drug protein binding studies
HPLC imidazole moiety
HPLC of Amoxicillin and Clavulanate
HSA/LC Competitive Binding Experiments
Huge standardized residuals
Human ADME with recombinant protein drugs
Human intestinal permeability of ibuprofen
IB for BA-BE studies
IC90% EMEA
ICH format for ANDA submissions
In vitro, in vivo and in silico models predictive of human PK?
In Vivo Brain Perfusion - pH of medium
In vivo precipitation effect
In Vivo Rat Brain Perfusion
Inclusion complexes of beta CDs
Increasing Linearity in Electrospray LCMS
Inhalation delivery
Inhibition of CYP2C19
Inhibitor
Inhibitor of UGT
Injectable Suspension for SC/IV
Internal Standard
Interspecies differences in PGP substrates
Intestinal perfusion technique
Intestinal time in mouse
Intestinal transit time and Tmax
Intrinsic clearance calculation
Ion Pair Chromatography
Ion Suppression - Li vs Na Heparin
IP/Oral POC Formulation
Isomannide mononitrate
IV bolus
IVIVC and IVIVR
IVIVC and IVIVR
IVIVC software
Kinetica for Population PK/PD Analysis
Kinetics calculation from substrate depletion rate (microsomes)
Korsemeyer peppas constant
Labrafil M2125, Maisine 35-1, Peceol
Lagrangian interpolation
Lamotrigine BE studies
Last Chance
Launch of the Free Web Based Pharmacometrics Learning Resource supported by ACCP
LC Assay problem
LC peak splitting
LC-MS/MS Assay Development
LCMS Assay problem
LCMS Variation in Response vs time
Lead selection / Ranking compounds
Levodopa BBB kinetics
Levothyroxine BE Study
Linearity
Linearity in APCI and ESI
Linearity of Risperidone tablets 0.25 mg
Liquid Scintillation Counting
Llinezolid determination in tissues
Locally acting GI drugs
Log normal distribution of PK parameters
Long time required to reach equilibrium
Looking for 2'-fluorodeoxycytidine nucleoside
LOQ and linearity range
Low Dose Bioequivalence
Low pH IV dosing to rats
Males vs females
Mass balance in non rodents for US IND
Mass transport models
Matrix Effects in LC-MS of Plasma Samples
Matrix Effects in LCMS from Phospholipids and Lysophospholipids
Mean Absorption Time
Measurement of Pegylated Interferon alpha 2a and 2b in plasma/serum
MEC Famotidine
Mechanism Based Elaboration
Metabolic clearance
Metabolism by A549 Lung Cells
Metabolism experiment
Metabolism Fluorobenzoxy derivatives
Metabolism question
Metabolism questions
Metabolite study
Metabolites assessment
Metformin HCl and Glyburide tablets dissolution
Method to compare two different plasma profiles
Method validation, HPLC Specificity
Methotrexate assay
Metoclopramide bioequivalence
Microdosing
Miglyol in the dog
Model selection
Model validation question.
Modelisation method question
Monitoring of BE studies
MONOLIX-SAEM
Morphine IV admin simulation in human
Multiple comparison Test
Multiple dosing in WNL
Multiple dosing regimen for User Defined Models in WinNonlin
Multiple Oral Dosing Two Compartment
Nasal perfusion technique
NCE Metabolism
NCE stability in the intestinal fluids
Need absorption data for a drug
Neural network QSAR
Neutrophil transit models
New ACCP Student Outreach Initiative
New networking group for Modeling and Simulation
New Version of Enterprise Pharmacology Series v2.6 Now Available
Non steady state pharmacodynamics
Non-enzymatic/physiological hydrolysis of esters
Non-linear kinetics
Non-linear PK
Nonlinear PK
NONMEM model help
NONMEM versions
Nonparametric method for average BE study
Nonparametrics analysis - TMAX
Number of cells per liver weight
Number of data points in BA/BE studies
NVT plot (Normality Variable Test)
OD Vs BD
Once Daily Dose of Amikacin in Cystic Fibrosis
Optimal Design Software
Oral administration in Monkeys
Oral Bioavailability
Oral bioavailibility and inflammatory diseases
Oral CL
Oral dosing volume in mouse
Outlier detection in Bioequivalence study
Outlier in BE
Oxcarbazepine and Cmax
P-glycoprotein
P-gp and CYP3A4-5 Exclusive Inhibitors
P-gp and gender
P-gp in mice
P450 experiment
Paclitaxel binding to tubulin
Paclitaxel Sink conditions
PAGE: the online journal
PAMPA-BBB
Paracetamol assay
Paracetamol PK in pigs
Parallel Design for Bioequivalence studies
PB vitro-vivo
PD targets for B-lactam antibiotics
PDx-MC-PEM v1.0
Peak concentrations following IV administration
PEG-400
Pellets Product Bioequivalence
Period and sequence effects
Permeability classification in Caco-2
Pharmacokinetic training
Pharmacokinetics of Ambroxol
Pharmacokinetics of thimerosal/ethylmercury
Phase I studies
Phenytoin Binding to Enteral Nutrition
Phenytoin PK Software
PI and BE software question
Pig Organ weights and Blood flows
Piperaquine assay
PK analysis
PK analysis question
PK Drug interactions
PK effect of Tween-80
PK of Solid dispersions in rats
PK sample time deviation
PK samples Quantification using LCMS
PK samples when clinical study ends prematurely
PK study in rats - acceptance criteria
PK Time points
PK/PD using MRS
pKa of Drugs
pKa of Primidone
pKa value and its significance in BE
PKAnalyst
PKPD modeling of antibiotics
PKS Client version 3.0
Plasma clotting
Plasma exposure excipient choice
Plasma sample extraction
Polynomial fit to calibration curve
Population PK software
Positive Pre-dose
Precipitation in blood
Preclinical Bioavailability
Preclinical interaction data with tPA for drug development in acute stroke
Preclinical programs for nasal vaccine
Prediction of K01
Prednisone
Primary cells
Processing frozen tissue samples for analysis by LC/MS
Prodrug analysis
Product for Phase I
Propranolol and atenolol oral absorption in humans
Protein binding
Protein binding and solid phase extraction
Protein binding by HSA columns
Protein binding in animal species
Protein binding using plasma versus serum
Protein Concentration for prodrug hydrolysis
Protein concentrations in S9 fractions.
Protein estimation in S9 fraction of rat liver
Protein phosphatase turnover rate
Protein precipitation
Protein turnover rate
Protocol for levothyroxine bioequivalence study
PXR assay
Q-Q PLOTS
Quadratic equation and LOQ
Quantification of geometric isomers
Quantification of rocuronium bromide
Quantity of Reserve Samples
Query regarding the statistical limits of similarity index (f2)
Question about trial simulator
Question on study design
Question on SXR/PXR antagonism
Questions on hot TD studies
Rabeprazole-Domperidone dissolution media
Radiolabeled erythromycin (not at N-methyl group)
Radiolabelled Statin
Rat and Mouse Intestinal Microsomes
Rat Intestine Microsomes Preparation
Rat Percent Body Weight Factors
Ratio of arithmetic means of Tmax for a modified release formulation
Reanalysis of Bioequivalence study samples
Recommend PK Textbooks
Record of deviation in sampling times
Recovery in a Bio Analytical method validation
Reference listed drug (RLD)
Reference on Oral Cefotaxime
Regarding enzyme kinetics by substrate depletion
Regarding internal standard for statins
Regarding minocycline modified release capsules 100 mg
Regarding onset and duration of two mechanisms producing same PD effect
Regarding the IP quantity needed for BE/BA study for Canada submission
Regarding Turbovap
Regulatory agency comments
Regulatory Guidance of Finland for Bioavailability and Bioequivalence Requirements for Generic drugs
Relationship between biliary excretion and route of administration (iv vs po)
Release of WinNonlin 5.0 and Pharsight Knowledgebase Server (PKS) 3.0
Reliability of drug metabolism in hepatocytes in vitro
Renal Reabsorption
Repeat analysis
Repeat assay
Repeats for PK reason
Reporting very high ka values
Residual blood volume in animal tissues
Results below the LOQ
Rhesus versus cynomolgus monkeys
Risperidone and 9-OH Risperidone
Risperidone exposure in children
ROA Formulation References
Rocuronium determination
Route dependent disposition
Roxithromycin assay
S-plus and trapezoidal method
S9 in drug metabolism study
Safety Capmul Captex
Safety Testing of Drug Metabolites
Salicylic acid determination in tissues
Sample analysis repetition
Sample retention MCC submission
Sample Size Calculation and Washout Period
Sample size for a parallel study
Samples from injured ambulatory subject
San Franscisco Bay Area PK/PD network
Seeking a product with a high maximum wavelength absorbance
Sensitivty loss in LC/MS/MS analysis
Separation of d8 IS from non deuterated analyte
Serial blood sampling from mice
Serial blood sampling from rats
Serum or plasma for BE studies
Serum Pro-drug Stability
Sibutramine and lopinavir
Simulating infusion response based on a single bolus data
Simulation instead of clinical trial
Simulations instead of actual study
Simvastatin Dissolution
Single pass perfusion model validation
Software comparison WinNonLin vs Kinetica
Solubility determination
Solubilizer to be used for in-vitro expt
Solubilizing problem
Solution of a particular compartment model
SOP for preclinical studies
Sorbitol interaction
Species selction for PK screen
Specific antibodys for monkey or human p450 isoforms for western blot
Specific CYP 3A probes
Standard body weights
Standard curve of an ester drug
Standard Two Stage vs NONMEM vs PEM/NPAG et al
Standardization of PK Symbols
Statistical analysis without Ln transform in BE study
Statistical method to establish dose proportionality
Statistical test for three sequence three period BE test
Steady state and WinNonMix
Steady state BE studies
Steady state prediction of sustained release systems using Winnonl in
Strategies improving gastric stability
Structure Pharmacokinetic Relationship
STS
STS defined
Study design: effect interaction
Subject effect
Subject is absent for ambulatory samples
Subject-outlier
Suitable APCI compound
Suitable HPLC column for the gastric stability studies
Survival Analysis
Survival Analysis question
T/R Ratio & bioequivalence study
Talinolol - P-gp substrate
Ten fold difference in Half-life following IV and PO
The conversion law
The Separation Principle
Therapeutic concentration of the Tacrolimus
Therapeutic index
Thermo Electron Launches Kinetica Resource Webportal
Thioridazine bioequivalence
Three way cross over design
Time and dose dependent decrease in Cl/F
Time but not concentration dependent CYP inactivation
Time points
Time-dependent PK model
Tissue - blood partition coefficient
Tissue kinetics
Tissue volume and blood flow in rats
Titration study
Tolbutamide metabolites
Tolerance limits on IV solvents
Topical dosage forms
Toxicity formulation question
Toxicology e-mail list?
TPMT and SAM
Training on population PK and Monte Carlo simulations
Transporter studies
Tumor hypoxia and PK
Turnover data
Tween 80
Unequal washout periods for 3 way crossover study
Unequal washouts during BE studies
Use of positive substrates in CYP phenotyping studies of NCE
Use of TPGS in IV
User MM-model in WinNonmix
Using internal standards in HPLC kinetic study
V(d)s for Rxs
Vacutainers
Valsartan BCS classification
Vancomycin and Trough levels
Vehicle dependent changes in PK parameters
Venlafaxine HCL BCS
Very high plasma clearance
Very highly protein-bound drugs
Vincristine optimal PK sampling
Vitamin D assay method
Volume distribution of acidic compound
Volume of dissolution medium
Volume of distribution
Volume of Distribution and Accumulation
Vomiting
Waiver of BE studies reg
Waivers of Bioequivalence studies
Washout period for 3 way crossover bioequivalence studies
Weighting for population PK
Western Blot
What is therapeutic level of Itopride in human
When is a target concentration effective and when is it toxic?
WinNonlin dissolution test
WinNonlin Question
WinNonlin reinstallation problem
WinNonlin validation
WINNONLIN(R) VALIDATION SUITE(TM)
WinNonmix code
Withdrawing of blood from the volunteers
WNL 5.0.1 released
Zero order kinetics
Zwitterion

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