PharmPK Discussion List Archive - 2004

PharmPK Discussion List Frequently Discussed Topics

1,2 propandiol as a solvent
1991 and 1993 Editions of the FDA's Inactive Ingredient Guide
6 beta hydroxylovastatin
90% confidence interval
96 well format-preparation of stock solution
About 2-step PK/PD model template
Absolute bioavailability
Absorption constant
Absorption delay question for Adapt II users
Absorption from the stomach and duodenum
Absorption kinetics
Acamprosate calcium lc-ms-ms method
Acid vs Salt form Bioavailability
acslXtremeR PBPK Modeling Software
Actual and planned sampling times
Adalimumab
ADME optimization
ADMET
Adverse events in bioequivalence studies
AKAIKE criterion
Albumin binding
Alendronate bioavalability and bioequivalence
Allometric scaling - use of WT power function on ka and Tlag
Allometry
Allometry for compound following different compartment model across the species
ALP (PPi Activity)
Altered PK in diabetic vs. normal animals
Amiodarone tablets
Amodiaquine metabolite
Analysis of carvedilol and celecoxib in human serum
Analysis of drug in bile
Analysis of glimepiride in human serum
Analysis of metabolites in urine
Analysis of parallel design in bioequivalence studies
Analysis of simvastatin in human serum
Analyte recovery
Analytical reason of incubating the drug with blood
Animal bioequivalence injection model
Animal studies
Antibodies antibodies for rat/rabbit CYP1A1-2
Antidiabetics interaction studies
Antihistamine PK
Application of fujitaban model
Assay question
Assessment of ligands of xenosensors
Atovaquone pharmacokinetics
Atypical Michaelis-Menten Kinetics in microsomes
AUC and BE
AUC and Cmax
AUC calculation
AUC calculations
Availability of debrisoquine
b-Cyclodextrin formulation
BA/BE of Anti-Diabetic Drug - GLICLAZIDE
BA/BE of Different Strengths
Bailer Satterthwaite AUC and Variance calculations for sparse data
Bayesian Forecaster Software
BCS classification
BE 'common' duration of sampling
BE of nicotine patch products
BE studies for biogenerics (rDNA protein medicines)
BE studies for calcium, folic acid
BE studies for orally disintegrating tablets
BE Studies in UK & EU
BE Studies modified release generic
BE Studies on modified release generic formulations for Europe
BE studies: single dose or at steady state
BE study for orally disintegrating tablet
BE study for orally disintegrating tablets
BE study in animals
BE waivers
BE with Levodopa
BE/analytical study of vinpocetine
Benztropine
Beta-blocker lipophilicity
Bile duct cannulated rat/mice
Bioanalytical lab supervisor to support toxicokinetics
Bioavailability food effect and man vs animal
Bioavailability issue
Bioavailability profile of NCE for development
Bioavailability statistics
Bioequivalence and bioavailability
Bioequivalence Limit
Bioequivalence studies
Bioequivalence studies for topical products
Bioequivalence studies in India
Bioequivalence trial with alendronate.
Biological qualification of an unstable impurity
Biomarker assay validation
Biovailability
Blood collection for mouse PK studies
Blood partitioning of NCE and calculation of CL
Blood sample volume
Blood samples from cannulated rats
Blood sampling time points
Blood vessel distribution in human and rat skin
Blood volume formula
Blood volume formula and Lots of Other Goodies
Bollman - type cages
Brain / plasma drug concentration ratio
Brain penetration
C max for Oxcarbazepine
Caffeine
Calculation of distribution half life and Absorption rate constant
Calculation of exposure
Can Creatinine Clearance be used as an PD parameter for PK-PD analysis
Capsule administration to rats
Captopril absorption
Cardiac output, physiological values
CDEX Complexation constant
Cefadroxil Bioequivalence
Cells and fluids in bone marrow
Cellular mathematic models
Changing formulation during drug development
Chemical vs plasma hydrolysis
Chewable tablet administration modality
Chiral separation
Choice of dissolution media
Chronopharmacokinetics and rodent PK
Cidofovir mucosal absorption
Clarithromycin Metabolite
Clearance
Clearance - Pharmakokinetic database
Clearance and distribution volume and T-half
Clearance Values
Clinical Pediatric Sites - Healthy Volunteers
Clot and temperature sensitive
Cloxacillin assay
Cmax and Cmin
Cmax At 2 hours after IV bolus
Cocktail to study CYP inhibition
Coefficient of Variation
Combination BE study
Comparison of first and second order rate constants
Comparison of IV AUC and IP AUC
Concentration Correlation Blood Hepatocytes
Concentration measured higher than administered
Confidence interval
Control for microsomal incubations
Controlled Release-Database
Cortisol assay method
Cosolvent for iv administration
Cosolvents/surfactants in iv formulations for pre-clinical studies
Cp versus tumor ratio
Cross over-parallel design-AUC 72h
Cu = Cut
Culturing rat hepatocytes
Curve fitting for data points family
Cyclophosphamide metabolite
CYP Induction
CYP Induction: Mouse to Human correlation?
CYP2D6 activity (AHMC/AMMC)
CYP2D6 substrates
CYP3A4 induction after nasal administration
CYP3A4 polymorphism
Cytochrome P450 questions
Decreased response in LC-MS/MS
Degree of blood pressure drop after long-acting nitrates
Determination of protein binding
Determination of toxicity of a difficult to isolate impurity
Determining ka from non-compartmental analyses
Dextromethorphan and verapamil concentrations
Dextromethorphan Verapamil plasma hepatic cell relationship
Difference between serum and plasma
Differences in Half life
Different disposition pattern in the same species
Different dissolution rates for different strength
Different drug formulations
Different drug salt forms
Differential equation for Higuchi kinetic
Digoxin and P-gp in monkey
Dimethylacetamide as Dosing Vehicle
Diphenoxylate
Dissolution media for Amlodipine besilate tablets
Dissolution media for glipizie and nateglinide
Dissolution profile comparison
Dissolution profile similarity in three media
Dissolution question
Dissolution, Bioequivalence, Bioavailability
Distribution of P450 isozymes in rat liver
DMSO for IV administration
Docetaxel metabolism
Does tween concentration matters
Dog absorption vs humans
Doing BE analysis using Winonlin
Dose conversion
Dose for BA Study
Dose-effect Analysis with Microcomputers software
Double, triple or more peak phenomenon
Down regulation of transport function in vitro
Drinking water in BE study
Drug absorption
Drug concentration in bile
Drug concentrations in bone
Drug determination from bone marrow
Drug glutathione conjugation
Drug interaction studies in cancer patients
Drug Metabolism Discussion Groups?
Drug PK Interaction question
Drug Solubilization: Pre-Clinical Studies
Drug stability in simulated fluids
Drugs PK related to polymorphic type
E/H recirc and FP effect
Effect of dosing regimen on chemical absorption and excretion
Effect of pollution particles
Effects of renal impairment CL
Efficacy results population
Efflux pumps on tumor cell lines
Electronic submission for JPKPD
Endogenous IgG Vd and t1/2 in rats
Enteric Coated Paracetamol-Acetaminophen
Enterohepatic circulation after IV and IM
Enterohepatic cycle variability?
Enzyme inhibition equations
Erythromycin Ethyl Succinate
Essentially similar drugs
Essentially similar products
Ester metabolism
Estimating gut absorption for metabolising molecule
Estimating parameters of Hill equation
Estimation of the number of subjects
EU guidance on modified release - bioequivalence
Everted sac vs. Ussing diffusion
Evolutionary pharmacokinetics
Ex Vivo and In Vitro Studes Large Animal Livers
Exclusion of outlier data points in animal PK studies
Experience with vancomycin in neonates
Extent binding of acids to albumin
Extraction method
Extraction of amiodarone from Bile
Extrapolate 72 hrs concn data to 168 hrs
F%
F% of HPbCD
Factors for allometric scaling
Fampridine-SR (4-aminopyridine)
Fasting bioequivalence
FDA guidelines
FDA HPB - Raw materials
FDA labeling using simulation
FDA Requirement
Fixed Dose Combination Products
Fluorescence procedure to measure serum protein binding
Flurbiprofen hplc assay
FMO1 is flavin monooxygenase
Formula for calculating Intrasubject CV
Formulation for mouse PK study
Formulation in Ph-I to Ph-IV
Fraction of a free drug in plasma (alpha)
Fractional areas for extravascular administration
Free drug estimation
Gastric emptying time
GC capabilities
Generic drug as a RLD
GI Transit times
Glipizide Invitro Dissolution Medium
Glucose production rate
Glucuronidation of NCE
Good dissolution and poor bioavailability
Guaifenesin
Guidelines
Gut sac drug transport study
Gut sac volume
Half life of drug
Half-life of human albumin
Half-life with nonlinear kinetics
Handling of early PK sample
Hemodialysis modelling
Hemolysis
Hepatectomy
Hepatic clearance
Hepatic impairment study
Hepatocyte Induction Studies: Positive Controls
HMG CoA reductase inhibitory potency
Homogeneity acceptance criteria of dosing suspensions
How to determine AUC at SS w/o trapezoidal rule
How to determine the steady state?
How to handle when there is a dropout in replicated design
How to take suspension for BE study
HPFA and Protein binding
HPLC - retention time
HPLC accuracy
HPLC analysis of statins
HPLC assay for metformin
HPLC method for propranolol
Human specific metabolite
Hydroxy triamterene sulfate
Hydroxypropyl-beta-cyclodextrin
IAM chromatography and passive diffusion
IC50 and rate constant
IC50 of CYP
Ideal age and weight of animals for PK studies
Identifiability software
Important pharmacokinetic parameters
In - vitro CYP liability studies
In Situ Gut Perfusion
in vitro drug-drug interaction studies
in vitro-in vivo relationships
In vivo CYPs Inhibition and Pgp
In-vitro ADME data
In-vitro metabolism studies+ Deuterated chemicals
In-vivo metabolite determination
Inclusion of reserve subjects in BE assessment
Increase/decrease in metabolite plasma concentrations with repeat dosing
Increased CL with dose
IND - Animal tox
Individual Bioequivalence Statistics
Induction of P-gp
Induction studies
Injectable Suspension for SC/IV
Inspection of a mfg site by Brazilian agency
Insulin Delivery
Insulin HPLC
Integration of compartmental models
Internal standard for LC-MS
Interpretation of Cmax
Interpretation of Emax
Interstitial Fluid Volume for Mice
Intestinal bile acid concentration in mice
Intestinal Microsomes
Intra subject CV%
Intracolonal application to rats
Intramuscular injection for Bioavailability
Inverse modelling
IP DMSO in mouse
IP Dosing
IP dosing with 1% methyl cellulose
Is allometry suitable for predicting PK parameters in cancer patients
Is API3+ suitable for intracellular nucleotide assay?
Isoniazid Cell Culture Lethal Dose
IV Drug Blood Solubility Files
IV precipitation
Justification for BE results falling just outside the limits
Justification for male vs female in ADME studies
Ka as a constant!
Ketoconazole pharmacokinetics variability
Ki Value determination
Kinetics, Dynamics and Compartmental Models
Km - Vmax determinations
LC - MS/MS
LC assay and pH, Hydrophilicity, pKa, Log P
LC-MS assay for Amodiaquine and Trimethoprim
LC/MS of analytes in Krebs Buffer
Leucovorin bioassay
Linearity
Linearity of PK after intrathecal elimination
Liquid liquid extraction from plasma
Liver blood flow and food
LLOQ
Log D and surface activity
Logarithm transformation % Bias
Looking for a Bayesian forecasting PK program
Looking for commercially available aldehyde oxidase and 7-hydroxy-methotrexate
Lopinavir by lc-ms-ms
Low adhesion 96-well plates
Low bioavailability drugs list
Low bioavailaility and drug development
Low Cmax values after IV dosing
Lung surface area
Mean Dissolution Time
Measuring Mg and K in urine
Mechanism based assays for P450s
Metabolic profile of poorly soluble compound
Metabolite Analysis in BE Studies
Metformin HCl and Glyburide tablets dissolution
Method for the determination of chondroitin
Methylcellulose in mice
Metolazone Bioanalysis
Microsomal metabolism
Microsomal Preparation Totality of Oxidation, Reduction, Hydrolysis and Conjugation
Microsomal protein content in different animal species
Microsomal study
Miglyol in dogs
Missing Values
Modeling of Transdermal drug delivery system
Monoclonal antibody pharmacokinetics
Monoclonal Antibody SC: absolute bioavailability correlation from mouse to man
Mouse PK studies
Mouse, Rat - Anaesthesia and Bleeding
MS/MS for isomeric compounds-reg
Mucoadhesive tablets
Multi-dose on bioequivalent studies
Multiple blood sampling in mice
Murine estradiol tissue distribution
Murine renal clearance
NCE formulation stability
NCE hepatoxicity in rats
NDA and ANDA
Negative base line/HPLC
Nicergoline analysis
Non human primate for research
Non-linear CL
NONMEM and compartmental modeling
NONMEM interface
NSAIDs Absorption
Number of study subjects
Obesity - diabetes friendly vehicles
Obesity and CrCl
Octanol water partition
Old and New P450 Nomenclatures
Omeprazole as a CYP2C19 probe substrate
Online PK/PD database
Oral absorption data
Oral bioavailability studies: rats vs. dogs
Oral Contraceptive study in post-menopausal women
Oral contraceptives induction study
Oral dosing to rats
Oral formulations for small animal pk
Outlier in bioequivalence
Outlier question
Oxcarbazepine Bioavailability
Oxcarbazepine bioequivalence study
P*w
P-glyco protein studies
P-gp in 3LL cell lines
P-GP species differences
P450 and lab animal
Paclitaxel (Taxol) extraction from animal tissues
Paracetamol HPLC
Parallel BE/BA studies
Passive membrane diffusion
PBPK- Modelling
PEG 400 sc
Percentage absorbed or oral bioavailability calculation from urine data
Percentage absorbed Vs. Papp
Perindroprilate SPE method
Permeability classification in Caco-2
PGP interaction study
Pgp protein turnover rate
Pharmacokinetic and pharmacodynamic interactions of metals
Pharmacokinetic and pharmacodynamic properties of Linezolid
Pharmacokinetic model repository.
Pharmacokinetic Software
Pharmacokinetic Studies of etoposide in Rats
Pharmacokinetics of gatifloxacin
Pharmacokinetics of interstitial fluids
Pharmacokinetics of placental transfer
Phase 1 sites
Phase I/II metabolism
Phase one clinical formulations
Phenytoin PK and enzyme kinetics
PK analysis of IP administered drug
PK and formulations
PK based NDDS
PK of modified release morphine, hydromorphone and oxycodone
PK parameters from truncated data
PK parameters in SS
PK profile of prodrugs
PK reanalysis
PK samples Quantification using LCMS
PK simulation software
PK study in patients undergoing peritoneal dialysis
PK-PD studies
PK-PD- Correlation Anti-Cancer drugs
PK/PD modeling of fast acting drugs
PK/PD section added to pbpk.org
pKa as a constant
pKa database
pKa of floxuridine
pKa of some drugs
PKPD Modeling question
Plasma binding issues
Plasma esterase activity
Plasma Interferences
Plasma vs Serum Samples for PK
Plasma-protein binding experiment design
PO IV half-life difference
Polynomial regression
POP PK study in pediatrics
Population bound limits in sims
Population PK
Potent - low bioavailable
Powder For Injection Formulations for US/EU
Pre-EOI concentrations > EOI
Precipitation of plasma proteins
Preclinical formulation for multiple doses
Preclinical PK-PD correlation
Prediction of in vivo data from invitro data
Product name changes
Propranolol and Atenolol assay
Protein binding
Protein Binding Study
Protein precipitation
Protein turnover rate
Quality Assurance in HIV TDM
Quantification by LCMS-reg
Quantification of siRNA
Question about drugs in clinical trials
Radiolabel to mice
Randomization schedule bioequivalence studies
Rat death under pentobarbital anesthesia
Rat intrinsic clerance
Rat IP bioavailability exceeding 200%
Rat renal parameters
Ratio analysis for bioequivalence
RBC and cyto-P450
RBC containing perfusion media
RBC partitioning experiment
rDNA BE studies
Recirculatory model website, and software examples
Recovery calculation in LC-MS-MS
Reference products TB Bioequivalence
Reference standard
Regarding Chow and Liu's Bioavailability and Bioequivalence book
Regarding CYP P450
Regarding extraction of Valdecoxibe
Regarding Reference standards for constituents of Turmeric oil
Regional absorption
Regional Absorption
Registration of Pharma Products in Brazil
Regulatory requirements for weight range and age
Relative bioavailability
Renal clearance
Renal Excretion of Drugs in Pediatric Patients or Normals
Renal function age and gender
Replicate Design - Individual Bioequivalence
Reporting of MRT and Vss in clinical studies
Requirments to Give Licenses to Lab related to Drugs Studies
Research topic with beta blockers
Review on drug interaction
Rifampicin solubility
Rosiglitazone preclinical data
S.E. for AUC
S9 scaling up
Sample size calculation
Sample size calculation for Bioequivalence
Sample size in clinical trials
Sample times for tissue distribution studies
Sampling from cardiac tissue
Saquinavir assay
Satherthwaite df in BE studies
Satterthwaite AUC and Variance calculations for sparse data
Sawchuk-Zaske method
SC Bioequivalence
SC or IM Dose Scaling Man to Rabbit
Scale-up factor in Pgp-mediated efflux kinetics
Sequence effect on sequential study design
Serum or plasma
Simethicone interacts with glucose, palmitate or L-leucine
Simvastatin Dissolution
Site of absorption of norfloxacin
Software for population PK
Sojourn time density function
Solubility measurement
Solubility problem
Solubilization of water insoluble drug
Solvent for dissolving some extracts
Source for human liver microsomes
SPE - total or only free drug detected?
Spectrophotometric (UV-visible) method of estimation
Standard curve of an ester drug
Statistical test for dose proportionality
Storing BE samples
Streptomycin Assay
Subject Compensation in BA/BE
Subject Sample Analysis
Subjects for BE study
Sulbactam in human plasma by hplc
Synephrine
Systemic circulation
Tablet vs capsule strength
TDM Serum or plasma
The best calculation model needed for Drug Potency Tests in a cell-based assay
Therapeutic index (Cmax/MIC)
Thiamazole (methimazole)
Thiol glucuronidation
Time dependent PK
Time of efficacy testing in absence of PK data
Tissue experiment
Tmax
Tobramycin stability in plasma
Topiramate determination using HPLC
Total Stomach volume of a rat
Toxicity studies
TPGS assay
Tramadol - carbamazepine interaction needs to be revisited
Truncated AUC approach
Tubular secretion
Two peaks in plasma curve
Typical vehicles for oral formulation
Understanding first pass metabolism
Update on dermal absorption guidance
Urinary excretion of Mg, Ca, and K
US vs EU Bioequivalence requirements
Using metabolite to assess parent drug bioavailability
USP Dissolution apparatus qualification
UV light sensitivity
Valsartan permeability
Vancomycin continuous infusion
Vancomycin pharmacokinetics
Vd
Vehicle with no metabolic liabilities
Venlafaxine hydrochloride biostudy
Verapamil metabolism in male rat
Very high plasma clearance
Volume of Distribution question
Volume shift in Equilibrium Dialysis
Vss/F
Vz after IV and IM
Weibull function to fit dissolution data
What is a possible fate of a protein/peptide drug in vivo
When we can use SAS PROC GLM and SAS PROC MIXED
Which is the best method to examine fraction absorbed in rats?
Which triple quadrapole instrument is suitable for high throughput quantitation
Whole blood partitioning
Why a lower point in the dissolution profile
Why median Tmax
WinNonLin - physiological pharmacokinetic model
WinNonlin Data entry for Deconvolution of oral dose
WinNonlin diagnostics
WinNonlin simulations of metabolite kinetics
WinNonlin Table Wizard Question
WinNonlin Validation of Michaelis Menten Model
WinNonmix error messages
WinNonMix professional 2.0.1
WNL user defined model - conc below zero
Zero over lamp lights up/HPLC

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