PharmPK Discussion List Archive - 2007

PharmPK Discussion List Frequently Discussed Topics

6beta-OH-cortisol/cortisol ratio
90% Confidence Interval for Tmax
AAPS-FDA Drug stability recommendations
Abacavir assay calculation
Absorption versus elimination
Absorption window
Acceptable IV vehicle for reproductive studies
Acceptance criteria for bioanalysis
Acceptance limit of 75-133%
Aceclofenac BCS
Activation of CYP in HLM
Active metabolite
ADAPT II installation on Linux/Unix platform
Adding subjects to BE study
Addition of the IS in aqueous solvent
Alcohol pks
Allometric scaling and bioavailability
Allometric scaling of blood clearance or plasma clearance
Allometry and Dedrick Plots
Alpha and Beta Half Lives
Amidase and Phosphatase Inhibitor in Blood
Amikacin target levels in cystic fibrosis
Amiodarone biostudy
Amlodipine BE
Amodiaquine assay
Amount in Capsule Guidelines
Analysis of caco-2 permeability samples
Analysis of incurred samples
Analysis of nitroglycerin
Analytical and duplicate plasma samples
Analytical method for Rabeprazole + Domperidone
Analytical method of nitroglycerin
Angiotensin analysis
Animal Drug classified as pesticide
Animal model for drug interaction study
Animal models of diabetes for PK studies
Apparent species differences in absorption.
Arishel Newsletter, Issue 1, 2007
Arishel Newsletter, Issue 2, 2007: DUI PK
Arishel Newsletter: No 3, September 23, 2007
Artemisinin in liver tissue
Assay revalidation
Assay for drospirenone
Assay of Amodiaquine HCL from Urine Samples
Assay revalidation
Assessment of dose proportionality
Atorvastatin assay BE study
AUC calculation
AUC0-last and AUC0-inf
AUCratio
Average, Population and Individual bioequivalence
Azithromycin absorption and food
Azithromycin Suspension Dosing
BA - BE Study for an anti-cancer drug
BA BE study
BA studies of trypsin and chymotrypsin
Baseline analysis of Testosterone
Basic Buffer for LC/MS analysis
BCRP efflux inhibitors
BCS and Biowaiver by EMEA
BCS class
BE - truncation for ACE inhibitors for FDA
BE Food effect
BE for modified released product
BE Guidance Fed
BE guidelines for Sri Lanka
BE requirement for opthalmic product
BE studies
BE studies - glucose tablets to prevent hypoglycemia
BE studies Ramipril and Ramiprilat
BE study - Dose
BE Study design for highly variable drug
BE study for drug used for female patient
BE study inclusion of male and female subjects
BE study of anti-TB formulation
BE study of Aprotinin
BE study of Bicalutamide
BE study of Clopidogrel
BE study on lower strength for simple molecules
BE study restrictions
BE study results
BE study with chewable tablets
BE study with esomeprazole
BE study with non RLD strength
BE Time points
Below LLOQ sample
Benztropine
BEQ studies with large sample sizes
Beta 2 Microglobulin and aminoglycosides
Biliary excretion and unchanged drug in feces
Bilirubin conjugates
Bioanalytic method validation survey
Bioanalytical assay for pre-clinical study
Bioanalytical guidelines acceptance criteria
Bioavailability of chymotripsin
Bioavailability with high first pass effect from sustained release formulation
BIOCUBE
Bioequivalence and PUMA
Bioequivalence Guidance Cheat-Sheet in Excel
Bioequivalence leuprolide depot formulation
Bioequivalence of calcium carbonate
Bioequivalence of Drug Products for ANDA submission
Bioequivalence of inhaled formoterol
Bioequivalence of Loratadine
Bioequivalence of orlistat
Bioequivalence study of Alendronate
Bioequivalence study of Artemether - Lumefantrine under fasting condition
Bioequivalence Study of Topiramate
Biopharmaceutic Classification System
Blank interference
Blinding - BE studies
Blood removal and pharmacokinetics question
Blood sampling - mice
Blood volume formula
Blood volumes in physiologic compartments
BLQ values
Body Weight Standardization (Normalization)
Book on intepretation of mass spectra
Brazil requirement
Bupropion blood to plasma ratio
C0 in lungs following intranasal route
C24 higher than C8 in dog PK
Caco-2 cells troubleshooting
Calculation of clearance from 3 time points
Calibration curve acceptance criteria
Caloric intake in BE studies
Camptothecin analogues HPLC Analysis
Can acetonitrile be used to break the cells
Can we do the Meta Analyis of Bioequivalence Studies
Cannulated rat restrainer
Cannulation techniques for blood sampling
Capillary content in eye
Capillary Depletion
Cassette dosing formulation
Categorical PD model and correlating to IC50
CCI model of neuropathic pain
CDM Softwares
Ceftriaxone HPLC detection
Centrifugation of blood samples under cold conditions
Change in strain plasma
Change of parameters in validated Bioanalytical methods
Citicholine BE
CL and Vd
Clarification on IVIVC
Clarification on IVIVC and Metabolic Ratio
Clarifications regarding redosing study
Clearance
Clearance and elimination
Clearance computation in WinNonlin
Clinical Predictors of AUC
Clinical Trial simulations
Clinical trials
Cmax for Short Infusion
Code for Michaelis-Menten Enzyme Kinetics in WinNonlin
Comparation of PK studies
Compiler for ADAPT
Concentration at 0 hour
Confidence interval 90% in parallel designs
Confidence Interval for unbalanced study design - Ln transformed data
Conjugated metabolites
Conjugated vs unconjugated
Conversion of urine data to plasma data.
Correlation between drug in plasma and blood
CR Tablet of carbamazepine
CremophorEL as excipient in mice
CYP enzyme in rats
CYP induction
Cyp3A4 activity and enzyme turnover in hepatic impaired subjects
CYP450 human equivalents in rats or mouse
CYP450 interactions and hepatic extraction ratio
Data Archival
Data point outlier
DCGI permission to start Bioequivalence studies in new clinical facility
DDI potential
DDI study
DDI with hormonal Contraceptive
Decision Criteria for re-analyzed PK samples
Delayed Tmax after IV administration
Derivatization of Alendronate
Determination of drugs in tissues
Determination of Tissue levels in rodent PK study
Diet effect on PK
Differences in half-lives with different doses
Digoxin and ECG
Dissolution of oxcarbamazepine
Dissolution profile comparision
Dissolution profile limits
DMSO absorption
Does the correlation exist between Vdss and Ptp
Dose calculation
Dose Dependent Plasma binding.
Dose for appropriately calculating bioavailability
Dose for bioequivalence study
Dose Linearity
Dose lost during BE study
Dose Proportionality
Dose proportionality
Dose selection for administration via nasal route
Dose-normalization kinetics
Dosing interval - lost dose
Dosing past tox studies
Double peak phenomenon
DPYD IVS14+1G>A reference sequence
Drug blood levels determination
Drug extraction from feces
Drug interaction data - Inhibition mode
Drug Metabolism enzymes in lungs
Drug solution sterilization in cell culture
Drug vehicle for PK study via nasal route
Drugs list with nonlinear absorption
Efect of withdrawn samples
Effect of inorganic buffers, metabolic stability and LC-MS-MS
Elimination
Emesis during BE study
Enantiomer specific COA
Encapsulation of liposomes
Enoxaparin in morbidly obese patients
Enterohepatic Circulation in Rats - Physiological Concentrations
Enterohepatic recirculation in the rat
Enzyme(s) catalyzing hydration in the rat
Estimation of Emax and EC50 in WinNonlin 5.2
Ethics of orbital sinus extraction of blood
Exemption of BE studies in cases of no systemic absorption
Exposure using Cmax and Cmin following multiple SC dosing
Extraction in presence of guanidine
Extrapolation in Bioequivalence studies
F relative in parallel designs
Fasted fed BE study
Fatty acid Extraction from Biological matrices
Fatty acids extraction
FD4 for intestinal permeability assessment
FDA Lab Registration
FDA Registration
Fed condition media
Felbamate BE study
Fluctuation & Swing
Folic acid and pthalyl sulphathiazole dissolution
Formula for Css after multiple IV Infusions
Formulation question for Guinea Pig IV study
Fraction absorbed
Free Online ADME Prediction Tools
Free sample size calculator for Excel
Gavage Solution pH
GC-MS analysis of pesticides
GCP Guidelines country specific
Gender in BE
GI motility
Glimepiride BE study Brazil
Glimepiride in vitro dissolution
Glimepiride invitro dissolution and estimation problem
Glucose kinetics
Glucoside conjugates
Glucuronide metabolite reactivity with HSA
GST-fusion protein - protein binding
Guar Gum
Guidelines for infusion time
Guidelines for Lebanon
Gut Efflux Transporters and (MAD/Intact Drug Bioavailability)
Half-life prolongation with increasing doses
Hematuria
High total clearance and high bioavailability compound
Homogenization of Skin
How to determine LLOQ
How to obtain GF120918
How to report no peak detected in pre-dose samples
HPLC assay for paracetamol, ibuprofen and caffeine
HPLC assay Serrotiopeptidase
HPLC column shelf life
HPLC Peak tailing
HPLC UV lamp problem
Human Intestinal Efflux Transporters
Ibuprofen BCS classification
Importance of kel and t1/2 in truncated design
In vitro in vivo correlation of naltrexone
In vitro intrinsic clearance measurement in cryopreserved hepatocytes
In vitro-In vivo contradiction
In-vitro clearance from liver microsomes data
Indomethacin sensitivity
Induction of P-glycoprotein by rifampicin
Inhibition of glucuronidation activity
Inhibitor of peptide uptake in the gut
Initial CYP ID Screen
Insulin aggregation
Insulin assays
Insulin PK/PD data
Interference peak assay in betahistine assay
Interfering peak - oxcarbazepine assay
Interindividual variability in ex vivo plasma protein binding
Interspecies scaling
Interspecies scaling of monoclonal antibodies
Intestinal Transporter Rat + Minipig
Intra-species PK scaling from adults to infants
Intra-subject variation calculation
Intracellular concentration in tissues
Intrasubject CVs
Investigator Vs IRB Member
Invitro Bioequivalence testing
Irinotecan Fluorescent-HPLC method
Irinotecan-Topotecan-SN-38 HPLC-UV method.
Irregular dosing
IV infusion
IV plasma curves with an apparent 'absorption phase'
IVIVC
IVIVC - multiple doses study
IVIVC for developing Generic Product
IVIVC Studies
K3EDTA usage
Ketoconazole and efflux transporters
Ki, inhibition constant
Korsemeyer peppas constant
Labeling revision thought question
Lansoprazole Intra CV
LC-MS assay for Amodiaquine
LC-MS assay for Amodiaquine and Trimethoprim
LC-MS Metabolite interference
LC-MS-MS
LC-MS-MS actein method
LC-MS-MS instrument differences
LC-MS-MS Method for caffeine metabolites and lauric acid
LC-MS-MS question
LC-MS-MS sensitivity
Leflunomide metabolite A77 1726
Linezolid Formulation question
Liquid Liquid Extraction
Liquid phase microextraction
Liquid Scintillation Counting
Liver S9 fractions
LLOQ
LLOQ endogenous compound
Log linear distributions
Long-term Stability of Metabolic Enzymes
Lucifer yellow test with MDCK
Lung PK model
Lung tissue levels
MABEL for Biologics
Matrix effect
Measuring Plasma Protein Binding of Small Peptides
Metabolic Ratio
Metabolite characterization using LC-NMR
Metabolite clearance
Metformin availability
Metformin drug interaction
Metformin SR formulation and GI motility
Metformin, gereric drug registration
Method Development for Tissue samples
Method development validation in mouse urine
Method of ethinyl estradiol
Method validation and endogenous compounds
Microcapsule for oral dosing in mice
Microdialysis Free and Total Concentrations
Microsomal protein denaturation agent
Mid-infusion higher than end of infusion
Midazolam dose for oral DDI
Minimum batch size - BE study
Mobile phase selection
Molar dosing
Most samples below LLOQ
Mouse dose
Multiple ascending dose protocol
Multiple oral dosing script in WinNonlin
Multiple peaks
Multiple receptor site binding
Nasal dose
Nasal drug delivery - Dose selection
NAT activity - expression
NCE Formulation question
NCE solubility in buffer
Neural networks in pharmacokinetics
New drugs in India - clinical trials - BE
New formulation Clinical trial
New site for Office of Translational Sciences, FDA
Niacin metabolism and method development
Nifuroxazide
Nimesulide sustained release dissolution profile
Nitoglycerin bioequivalence
NonLinear Mixed Effects consortium: User Requirements Specifications (URS) Publication
Number of Capsules
Number of volunteers to be recruited for european guidelines
Obtaining formulations for bioequivalence studies
Organophosphate insecticide data
Outcome based evidence for merits of TCI/TDM
Outlier test
P-glycoprotein genotyping
P-glycoprotein western blotting
Pantaoprazole BE Study
Paracellular pathway in Goettingen minipigs
Paracetamol BE study
Paracetamol CR BE study
Paracetamol metabolites
Parallel Bioequivalence Study
Parameters related to AUC - WinNonlin
Paroxetine assay
Partial validation in plasma
PBPK model equation generator.
PBPK Model in Swine
PBPK modeling of controlled release preparations
pbpk.org is relaunched
PD and PK-PD correlation calculation
PD data analysis from sparse data point
PDx-MC-PEM population software new release
Peak fronting problem
pH across Rat GIT
Pharmacodynamic study of orlistat
Pharmacological availability
Pharsight Drug Model Explorer 1.6 Released
Pharsight WinNonlin Autopilot 1.1 Released
Physiologically based PK model
Pittman Morgan Test and Bioequivalence
PK analysis of a protein compound
PK for Endogenous Substances - Fully Adjusted Background Model
PK in marmosets of monoclonal antibodies
PK model for maternal-placental-fetal transfer
PK of Benzylpiperazine
PK of males vs females
PK of tacrolimus
PK Profile
PK Puzzle
PK studies for small molecule
PK studies in FVB mice
PK-PD modeling vacancies available in the Netherlands
PK/PD survival analysis
Placebo in a clinical trial
Plasma flow rates
Plasma protein binding utilizing 96-wells micro-dialysis plates
Population Optimal Design ListServer (PopDesign)
Post marketing surveillance conference
Post marketing surveillance study
Poultry pharmacology
Pre-clinical PK and gender
Predicting optimum buffer concentration
Predictive tools in bioequivalence studies
Pregabalin standard
Preparation of urine sample for LC-MS analysis
Probenecid cimetidine use in vivo PK studies
Problems with Caco2 cell resistance
Products for waiver
Promethazine formulation
Protein analysis - non-linear PK
Protein Binding and Drug Interactions
Pulmonary Delivery
QC test mix for LC/MS
QCs Acceptance
Question regarding QC LOQ
Radiolabeled Fe-accelerator mass spectrometry
Radiolabeled peptide
Randomization in BE studies
Randomization of Tox samples
Rat liver microsomes
Reasons to have >100% bioavailability for an NCE
Recombinant source of CYP450 enzymes
Red blood cell partition - technical advice
Regarding mobile phase
Regarding polarity
Regarding sample dilutions
Reinjection reproducibilty
Relative bioavailability and pharmacological availability
Release profiles of pH dependent drug
Removing Vitamin B12 from samples
Repeat BE Study
Reporting values below the LLOQ
Residual Blood Volumes in Rodent Organs
Retrospective Study Analysis
Rise in background noise in LC-MS/MS analysis
Risperidone Bioequivalence
Rivastigmine BE
Rivastigmine bioequivalence
Rodent IV-friendly formulations
Route of administration
Route of administration of nanoparticles formulations
S-adapt and Windows Vista
Sample collection for fasting and fed study
Sample preparation for quantitative analysis in dried blood spots
Sample size for BE studies
Sample storage temperature range of -70
Sample Time points for IV Infusion
Sample volume - LOQ
Saquinavir pKa
Scaling blood stability
Screening CNS drug
Screening of Plasma lots
Second peak with increasing oral dose
Selection of adult male rats
Selection of healthy volunteers
Selection of Ref Product of BE Study - US
Selection of stand-by subjects for statistical analysis
Separation of dextrorphan from gluconoride conjugate
Sequential BE Methods
Signing of GLP document
Similarity evaluation in Dissolution
Simvastatin Dissolution
Skin volume in rat, dog, monkey and human
Solubility problem
Solvents for human drug administration
SOP for assay procedure development
Source for acetaminophen sulfate
SPE system
Species difference and pharmacokinetic
Stabilization of Acyl Glucuronides in Urine
Standard placement
Statistical aspect of anti-cancer BE study
Statistical comparison of two drug concentrations
Statistical Moments Theory
Statistical outlier
Statistical Outliers BA/BE Studies
Steady state-infusion versus po dosing
Steady-state
Stock Solution Verification
Stripping rat jejunum
Structure of anti-drug antibody assays
Study design - Drugs with Long half life
Study procedures for BE studies
Subcutaneous in vitro model
Subject-withdrawal criteria
Summation of multiple ions in LC-MS-MS quantitation
System Suitability with in the batch
t1/2 value higher in IV than Oral
Tenofovir assay method
Testing of insulin on animals
Therapeutic index
Therapeutically relevant concentration
Thiols analysis
THU - deaminase inhibitor - blood collection tubes
Time points for metabolite
Time points for MR product
Timing of the availability of a bioanalytical assay
Tissue preparation for Liquid Scintillation Counting
TK analysis based on PK parameters
Topical dose calculation
Topiramate determination using HPLC
Total liver blood flow in Yucatan minipigs
Total propranolol and hydroxy propranolol
Toxicity associated with Cmax
Tuning LC-MS-MS
Tween 80 dose
Two peaks in plasma conc curve
Two submissions with one study
UGT 2B7 Metabolism
Unacceptable chromatography
Unavailability of same reference batch - repeat BE study
Unbound paclitaxel
Underpowered BE study
Update of www.rivm.nl/interspeciesinfo website
Use of Synthetic CSF for a Bioanalytical Method
Use of Total Drug Concentrations in Bioequivalency Assessment
USFDA form no.1571
Using PK model
UV estimation procedure for oxcarbamazepine
Validation and Qualification in Analytical Laboratories
Validation samples
Values of Aqueous solubility, logP and logD
Variability in fasting and fed conditions
Vd and Cl concept for a single po or IV dose
Vehicles for otitis media
Voglibose PK
Volume of a synovial fluid
Volume of distribution after loading dose and infusion of EtOH
Washout in Steady state studies
Washout period in BA/BE study
Water consumption during BE study
Weighted calibration curves
When are animal dosimetry necessary
Winnonlin Different doses
Winnonlin Problem
WinNonlin script to model two interacting drugs
Withdrawal versus dropout
Withdrawn discontinue drop out subject analysis
X ray
Zwitterionic compound and HPLC

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