PharmPK Discussion List Archive - 2006

PharmPK Discussion List Frequently Discussed Topics

1-hydroxy midazolam IV PK parameters
12-Hydroxy Lauric Acid
3A4 Polymorphism
4x4 Crossover BE
5 hydroxy omeprazole
90% CI in Replicated design
90% confidence interval for tmax
A question regarding Bailer's method
AAPS PPDM Recognizes in San Antonio
Acamprosate calcium lc-ms-ms method
Acid/base dissociation constant and its determination
Active inactive metabolites
Active metabolite
ADAPT II with SAMPLE option
Add on study in bioequivalence
Adipose and blood weight in mice
ADME data to support FIM
ADME software
Albumin clearance rates in synovial fluid from knee joint
Alcohol related dose dumping
Alfuzosin Absorption
Ames Test
Amine quantification
Aminoglycosides/vancomycin dosing software
Amlodipine
Amlodipine BE
Analysis of an I125 labeled peptide with WinNonLin
Analytical validation - combination products
Analyzing a derivative of 1,4-naphthoquinone
Animal/human dose
ANOVA
ANOVA calculation
Anti coagulant
Antibodies to Carbonyl Reductase
Application of positive or negative pressure in SPE
Aripiprazole BE 30 mg study
Assay for Vit E in bone
Assay of Drug in Plasma and Liposome Following IV Inj of Liposome Formulation
Assay validation
AST and ALT in mouse plasma
Atazinavir Bioequivalence
AUC inf Vs Auc all
AUC post-last dose in multi-dose PK studies
AUC% extrapolated
AUCtau correction for evaluation of effect of multiple dosing on PK
Automated NONMEM model selection patent issued
BA / BE studies for Yemen - Gulf region
BA studies of trypsin and chymotrypsin
Baseline analysis of Testosterone
Batch details
Batch Size Bioequivalence
BCS based biowaiver
BCS Class
BCS Class - Moexipril
BCS Class II/IV BE requirements
BCS classification - chlordiazepoxide, clidinium bromide
BCS Zolpidem tartrate
BE for ODT
BE procedure for topical preparation
BE retesting
BE studies
BE studies for insulin products
BE studies for Tablets VS Capsules
BE Study - Amodiaquine
BE study - concentrations below BLQ
BE study design acceptability
BE Study different batch for reference product
BE study for Injectables
BE study for nasal inhalers
BE study Guidance
BE Study of Combipack product
BE study of Ramipril using apple sauce
BE study with Paroxetine
BE Subject activity
Binding to lipoproteins
Bioanalytical and PK Experts for Biotech Products
Bioanalytical Calibration and QC samples
Bioanalytical inprocess - QA
Bioanalytical method validation
Bioanalytical Plasma QC samples
Bioequivalence
Bioequivalence analysed with Kinetica
Bioequivalence and Insulin
Bioequivalence for Low bioavailability drug
Bioequivalence on lower strengths: EU requirement
Bioequivalence requirements for Balsalazide and Olsalazine
Bioequivalence requirements for vitamins
Bioequivalence study for FDC
Bioequivalence study in animals
Bioequivalence study of Alendronate
Bioequivalence study of ethinyl estradiol
Bioequivalence: post-hoc adjustment of AUC
Biomarkers
Biopharmaceutic Classification System
Biowaiver - FDA Supac interpretation
Blinded placebo treatment in a clinical trial when urine color changes
Brain lipid supplier
Brain penetration
Brazilian PK Inspection
Bromazepam and BCS
Calculating GFR
Calculation of Bioavailability
Calibration curve
Calibration Curve Approval
Calibration curve by lc/ms
Calibration curve LOQ
Calibration curve model
Calibration curve selectivity
Calibration range
Can we ditch old ideas surrounding PK studies
Carbonyl reductase
Carryover in LC-MS/MS
Carvedilol bioequivalence study
Cell fractionation / cytosol and membrane isolation
Centrifugation Conditions
Cetirizine and Methyldopa
Chondroitin - glucosamine
Chondroitinase levels in plasma
Circadian variability
Clearance and elimination
Clearance comparison for nonlinear drugs
Clearance Question
Clinical Pediatric Sites - Healthy Volunteers
Clinical trial comparison
Cmax and AUC calculation in Single vs Multiple dose studies.
Coefficient of Variation
Coenzyme Q10 Solubility
Confidence Interval 75-133%
Confusion about the clearance of high-extraction drugs
Conventional vs CR BE study
Cost of PK Study - USA/Europe versus India or China
Cpss for aceclofenac
Creatinine clearance units
Creatinine half-life
Cremophor EL oral use in mice
Cremophor EL toxicity in mice
CV and worse
CYP 450s and Food effect
CYP inhibition
Database of pharmacodynamic (PD) parameters
DCGI approval procedure-BA/BE studies
DDEP availability
Decreased exposure at steady-state
Delayed distribution with monoclonals
Desferrithiocin
Determination of tibolone in body fluid
Diethylstilbestrol HPLC method
Difference between salt and ester of a drug
Diffusion cell
Diffusion study information
Diffusivity and absorption constant
Diltiazem - a substrate of OATP
Diluted QC Rejection
Dissolution media and sampling
Dissolution media for Amlodipine besilate tablets
Dissolution Media Questions
Dissolution profile similarity in three media
Dissolution studies on suspension ophthalmics
Distribution Phase
Distribution to skin and eyes
DMPK Departments in pharmaceutical co.
Do anticancer drugs affect Caco-2 cell lines
Does tween concentration matter
Donepezil HCl BE Study
Dose adjustment WinNonlin
Dose calculation for IM/ SC implants
Dose for repeat dose tox/TK study
Dose linearity
Dose optimization in drug development
Dose Proportionality Vs Linear Pharmacokinetics
Dosing for chewable tablets
Dosing of suspensions
Drinking water in BE study
Drinking water in BE study and gastric emptying
Drug concentration in bone
Drug Release Software
Drug stability in biological fluid
Drug transport through liver
Drug/metabolites concentration-time profile in urine
Drugs with very high Vss and high clearance
Effect of Alcohol on Dissolution
Effect of caffeine on drug absorption
Efficient way to precipitate protein
Emax model
Emetic Response in Dog
Enalapril maleate analysis
Esterase enzyme activity
Estimate multiple Taus (oral) in ADAPTII
Estimation of Nateglinide in plasma by HPLC
Ethionamide metabolites BE study
Ethnic Differences in Phase 2 Metabolism
EU Calibration Curves
Evaluation of Minimum Effective and Toxic concentrations - MEC/MTC
Excessive PK sampling
Exclusive P-glycoprotein substrate
Extraction detection of dimethylsphingosine
Extraction method question
Extraction of very polar analytes from plasma-brain
Extraction ratio
FD4 stability
FDA contact
FDA guidance on Human Radiolabeled Study
Fed BE study
Fed Studies
Fenofibrate dose proportionality
Fluconazole UV Assay
Fluorimeter
Food effect on ethinylestradiol/levonorgestrel oral contraceptive
Formulation question
Formulation screening
Fraction of drug absorbed from oral dose of domperidone
Fresh vs frozen curves
Fresh vs frozen sample standard curves
Ganciclovir PK
Gatifloxacin and urethane
Gavage Solution pH
GCP and GLP certification in india
GCP/GLP Contractors
Genotyping - Phenotyping
Gentamicin PK
Glimepiride dissolution
Glimepiride in vitro dissolution and estimation problem
Glimepiride particle size
Glipizide sustained release Dissolution Media
GLP
GLP for Phase I clinical sample assays
GLP training
Glucosamine sulphate
Glycated Hemoglobin Measurement
Griseofulvin Metabolites
Gut metabolism
Half-Life of Bicuculline
Half-life shorter for PO vs IV administration
Happy New Year
Help for definition in the study protocol
High clearance compound
High pH iv dosing to rats
High Protein Ligand binding stoichiometry
High tmax value
Highly Bound Drugs - Displacement Question
How far should we go in controlling conditions in BE studies
How to describe the elimination or disposition rule of a drug in tissue
How to differentiate ATP and dGTP in LC/MS/MS?
How to handle if the pre dose concentration is greater than 5% of Cmax
How to use a pbpk model in a ppk model
HPLC Cystatin C Biomarker
Human ADME Study question
Human ADME with recombinant protein drugs
Human Radiolabeled ADME Study
Humanised MAbs PK
Ibuprofen HPLC Assay
IM Dose calculation
Impartial witness
in vitro - in vivo correlation
in vitro clearance values
in vitro dissolution testing of glimepiride
in vitro evaluation of a mucoadhesive vaginal delivery system
in vitro metabolism - Amlodipine
In vitro Metabolism Data for Amlodipine
in vitro metabolism study
in vivo HPLC validation method for Ibuprofen sustained release
In vivo radio active mass balance/distribution study
In vivo Radioactive Measurements
In vivo Radioactive Measurments
In-vitro In-vivo Correlation
Individual BE study
Informed consent details
Infusion dose
Insulin bioequivalence
Insulin biosimilar (biogeneric) studies
Insulin clamp
Insulin extraction recovery
Insulin PK
Insulin quantitation
Insurance policies volunteers BA/BE
Inter-assay precision
Interference peak assay in betahistine assay
Internal area variation
Internal standard 2-hydroxybiphenyl
Internal Standard suitability
Interpretation of pre-dose conc analysis in steady state BE study
Ion trap to triple quad
IP DMSO in mouse
IP dosing with methyl cellulose
IP IM absorption mechanism
IS for LC-MS Regulatory view
ISDN analytical method
Iso-osmotic PEG-400
Itraconazole solubility enhancement
IV Dose selection
IV formulation - BE requirements
IV PK profile
IVIVC
IVIVC on nifedipine
IVIVC Toolkit for WinNonlin (Coming Soon) and WinNonlin 5.1 update
Ki and category of inhibitor
Ki determination using fluorescent probes for CYP450 enzymes
Ki inhibition constant
Kinetic parameters definitions for Infusion study
Km Value in Metabolism studies
Lactose absorption in the veterinary medicinal products
Large Vd
Launch interspecies website
LC-MS buffer volatility
LC-MS determination of paclitaxel in biological samples
LC-MS-LC analysis in urine
LC-MS-MS internal standard
LC-MS-MS Method Development - Boronated Compounds
LC-MS-MS method for atazanavir assay in human plasma
LC-MS-MS question
Least Square Mean
Leuprolide bioequivalence study
Linearity assessments
Linezolid and Rifampin Interaction
Lipophilic Drug from Liposomes Partitioning to RBC's volume and plasma
List of common acid and alkaline drugs
List of Poorly water soluble drugs
Lithium pharmacokinetic parameters (two compartment model)
Liver S9, experimental procedure
log P and MEC of glimepiride
Long term stability submission
Looking for adozelesin or carzelesin
Loratadine binding
Losartan potassium
Low bioavailability drugs list
Lucifer yellow test with MDCK
MAb's volume of distribution
Manage Phase I/POC studies in Herts
Mass balance
Mass balance recovery
MDRD equation
MDRD GFR equation vs. estimated CrCl methods
Measuring solubility
Mebendazole bioequivalence study
MEC of arvedilol & isosorbide 5-mononitrate
Mechanism based inhibition of enzymes
Metabolism of fluindioine
Metabolism of N-O-Glucuronidation
Metabolite id
Metabolite Tmax
Metformin Bioanalytical Assay by LC-MS
Methanol for s.c. infusion in rats
Methyl Ethyl Ketone
Micelles vs liposomes
Microarray data analysis
Microdialysis
Microdosing in humans
Migilitol bioanalysis
Miglitol assay
Milo Gibaldi
Mini pig as mamalian deveploment species
Missing Data
Mixed order absorption kinetics
MM-type kinetics WITHOUT Km/Vmax
Model independent approach for Comparing Dissolution Profiles
Modeling efflux transporter
Modeling interaction between antimicrobial and bacteria
MoSAiC: a NJ-Philadelphia networking group for Modeling and Simulation
MR versus IR
MRT for metabolites
Multidose BA/BE studies
Multiple dose study on fluoxetine
Multiple dosing code in WinNonlin
Multiple dosing two-compartment model
Multiple mode LC-MS-MS method development
Nasal Formulation
Need help regarding stability study of a drug in plasma matrix
Neomycin B assay
New PK book
Next Generation LogP prediction Software and Services
Nimesulide analysis
NLMEc: Non-Linear Mixed Effects Consortium User Requirements
No detectable concentrations in a BE study
Non-invasive pharmacokinetics
Non-specific binding in single pass in situ perfusion
Nonlinear PK and allometric scaling
NONMEM Modeling of Plasma + Urine Data
NONMEM multiple infusions
Norbuprenorphine
Normal distribution of PK data
Number of Data points and Parameters Estimation
Numerical deconvolution versus Loo-Riegelman method
Numerical optimization for 2-compartment model
Olanzapine BE Study
Optimal Dose Study
Optimal study design software available now
Optimization of dissolution limits
Oral clearance
Oral dosing of Aminoglycosides
Oral two compartment with MM elimination
Organic solvents for infusion into dogs
Outlier in BE Study
Outlier QC's during study sample analysis
Parameter estimate CV%
Parenterals approval requirements for BE Studies
PBPK modeling and simulation in Berkeley Madonna
Pediatric Collaborators Sought
PEG400 IV
Peptide PK
Perindopril Perindroprilate SPE method
Period effect
Peripheral vasodialators with minimal - no impact on BP
Permeability classification in Caco-2
Pharmacokinetic formulation problem
Pharmacokineticist skills
Pharmacokinetics of Ambroxol
Pharmasolve in IV
Pharsight releases WinNonlin 5.1.1
Phase I metabolism of Nifedipine
Phase III trial PopPK sample size
Phosphate Buffer for Equilibrium Dialysis
Physicochemical property information
Physiological parameters of guinea pig
PK analysis after portal vein collection
PK for Mazindol
PK for Nasal sprays
PK Information on Picotamide
PK of anti-TB drugs
PK of hydrochlorothiazide
PK of peptides
PK of Thiol NCEs
PK of water soluble compounds
PK parameters
PK trial
PK-PD model
PK/PD and in vivo tox studies of Monoclonal antibodies
PK/PD distribution and side effects of Monoclonal Antibodies
PK/PD studies
pKa of primidone
pka of the following drugs
PKPD of glucose-lowering drugs
Plasma protein binding for rapid metabolisers
Plasma vs. Serum
Plasma-protein binding experiment design
Pop PK sampling points and sample size
PopPK of Tissue Concentrations
Post study evaluation for safety of subjects
Potency difference
Povidone peptide interaction
Power and WinNonlin
Pravastatin BE study
Pravastatin bioequivalence
Pre dose concentration more than 5% of Cmax
Pre/clinical guidelines for evaluation
Precautions for LC-MS/MS method development
Preclinical tox studies
Predicting Human Exposure using Dog Data
Prediction of half-life in humans (carboxylic acid)
Predose sample in BE studies
Probe cocktail including P-gp and CYP2D6
Product with good response in positive and negative mode
Proficiency Testing in bioanalysis
Propofol infusion rate
Proportionally Similar Formulations
Protein binding
Protein Binding experiment
Protein binding pyrethroid insecticide
Protein Precipitation and Recovery
QC sample Rejection
QC samples
Query on dose proportionality
Question on clearance in plasma
Question on differences between Mauritus and Asian cyno monkeys
Questions on PBPK organ models
Quetiapine PK study
Rabbit and dog hepatic and kidney blood flow
Rabbits for BE studies
Radio-14C labelling of compounds in PK Studies
Radio-labeled insulin PK
Rat Intestinal Membrane Preparation
Re-integration of chromatograms
Receptor binding altering systemic PK
Recovery test
Red blood cell partition - technical advice
Regarding outliers in bioequivalence studies
Regarding single dose vs multiple dose study
Regarding single vs multiple dose studies
Regulations in Argentina
Regulatory Concern for System Suitability
Regulatory requirement for an ER formulation
Relationship between metabolism and hepatic extraction rates
Relevance of MRT
Repeat analysis
Repeated IV administration AUC
Reporting of interim models in Pop PK Reports
Reserve samples
Residual effect in bioequivalence study
Retention time difference
Reverse engineering of Wagner-Nelson method
Ritonavir and ketoconazole in QTc study
Rivastigmine bioequivalence
Rivastigmine bioequivalence study for generic application
Root mean square error or Mean square error
Roxithromycin dissolution
S/R script for file naming
S9 scaling up
SAE in BE studies
Safety - Tolerability
Sample size
Sample Size Calculations and BE Question
Sample whole blood
Sampling from guinea pigs
Sampling point for sustained release
Scopolamine half life
Selecting time points for combination of drugs for BE studies
Sequence effect
Seroconversion post-treatment
Serum Creatinine Rise
Sex related differences enzyme induction or inhibition
Should PK data be ln-transformed prior to using an outlier test
Sibutramine BE Study
Simple Statistics question in BE studies
Simulations for relabeling
Simvastatin DMPK
Single and multiple BE
Site changes
Skin absorption and metabolism
Skin Metabolism after Patch application
Sodium alendronate assay
Sodium sulfite assay
Solubility assay
Solubility issue in Drug Development
Solubility of enalapril free form
Solubility of Roxithromycin
Solubilizing problem
Solutol HS15 maximal dose in humans
Solvent for IP administration
SOP FOR Statistics
Species differences of metabolic enzymes in blood
Spiked samples (QC's) preparation
Sprinkles and Special Vehicles
Stability of imipenem
Stability studies in gastric fluids
Stabilizing urine pH
Standard placement
Standards for microsomes activity check
Statistical Analysis of a Pivotal Parallel study by using SAS
Statistical method for formulation and study interaction effect
Statistical outlier detection
Steady State
Steady state analysis
Steady state and long half-life
Steady State Cmax
Steady state study
Study Investigator
Supplier 96-well plates
Supplier of 2,4 dinitro fluorobenzen
Sustained release tablets sampling times
Table salt toxicity
Test substance above LLOQ in Baseline sample
Testosterone metabolites isomers
Time dependent parameter in Pharsight Trial Simulator
Time deviations handling Bioequivalence studies
Timepoints for tmax and t half
Tissue content in lysosome
Tissue Distribution
Tissue distribution study
Tissue steady state
Topical dosage forms
Topical preparation BE Study
Topiramate half-life
Topiramate stability in aqueous solution
TPGS Emulsion
TPGS Emulsion for oral drug delivery
TPGS in IV
Transdermal dose calculation
Transfer data from Watson to WinNonlin
Treatment effect
Tretinoin Pantaprozole Digoxin PK values
Triethlyamine
Triethylamine toxicity IV
Trimebutine Maleate
Truncated BE study
Tween 80 versus Cremophor RH40
Tween-80 PG and glycerine in oral liquids
Two compartment infusion equation
Two component Biostudy
UGT Isoforms / Marker Inhibitors
Unique Metabolite
Untransformed Analysis vs. ln-transformed Analysis - Bioequivalence
Urea in BAL
Urine levels of drugs of abuse
Ursodeoxycholic acid BE
Use of Surrogate matrix in place of Aqueous Humor in Ophthalmic BE studies
Use of Synthetic CSF for a Bioanalytical Method
Use of TPGS in IV
Using HPTLC
Vancomycin Dosing
Version 3 of PK-Sim released
Very high plasma clearance
Volume of distribution of enantiomers
Volume shift in Equilibrium Dialysis
Vz-CL for oral in winnonlin output
Waivers of Bioequivalence studies
Washout period in BA/BE study
Water restriction in bioequivalence studies
WBC Count after iv application in rats
Weighting factors with Excel
What is Clearance?
WHO approved bioequivalence centers
Whole blood partitioning
WinNonLin k01 = k10 model
WinNonlin micro and macroconstants
WinNonlin reinstallation problem
Winnonlin vs Kinetica for PK fitting
WinNonMix - 3 Compartment Model
WinNonMix and interoccasion
WinPOPT Release 1.1 beta now available
WLS using Excel
Xylanase activity analysis
Zinc sulfate

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