PharmPK Discussion List Archive - 2008

PharmPK Discussion List Frequently Discussed Topics

7Alpha Hydroxytestosterone supplier
Absorption pattern
Absplots Absorption Program and Rate of Absorption
ABT LCMSMS parameters
Acamprosate bioanalytical method
Acamprosate LCMS method
Acceptable % AUC extrapolation in BE studies
Acyl migration and liver toxicity
Add on Designs and Bonferroni correction
Allometric scaling
Allometry (MK or dog as an outlier)
Alteration of PK in animal disease models
Analysis of repeat C-t data in rodent toxicokinetic studies
Analysis of whole tumor sample
Analytical Method for Chlorhexidine
ANDA Preparation to submission
Announcing the Birth of Population Approach Group of India ( PAGIN )
ANOVA test DF
Anticancer drugs studies
Arishel Newsletter: No 4, February 20, 2008
Aspirin (81 mg) with which NSAID COX-2 Inhibitor
Aspirin Method Issues
Aspirin tissue distribution
Assay method for chlorzoxazone and 6-hydroxy
AUC steady state calculation
AUCt to AUCinf ratio
Average Bioequivalence ANOVA in R
Azythromycin in plasma
BA-BE data management
Batch acceptance and QC accuracy and precision
Batch acceptance issue
BCS class of Prazosin
BCS sulpiride
BE calculation in parallel study design using WinNonLin
BE in children
BE of combination oral liquid
BE of Highly Variable Drugs
BE or clinical study
BE studies of metered dose inhalers
BE study for liposome product
BE study on Paediatric dosage forms
BE study with esomeprazole
BE Working standard
Bimodal Distribution
Bioanalytical Methodology for Diphenhydramine
Bioanalytical methodology for Entacapone
Bioanalytical methodology for Valganciclovir
Bioequivalence for non-linear drugs (EU)
Bioequivalence in liposome drug product
Biphasic elimination
Blood flow protein binding coumarin metabolites
Blood sampling schedule
BLQ Value in multiple dosing (day n)
Caco-2 cell assay
Caco-2 permeability studies
Calculating Amax
Calculating amount absorbed from PD data
Calculating GFR
Calculation of AUC
Calculation of Expanded BE limits for Highly Variable Drugs added to FARTSSIE
Calculation of steady state concentrations in brain
Calibration curve
Calibration curves reinjected
Capmul MCM in dogs emesis
Carry over issue
Carryover in gradient program
Cell passage used in Caco-2 transport studies
Change of internal standard in LCMSMS method
Charcoal stripped plasma
Chart containing two Y axises by winnonlin
Chiral Chromatography
Chiral inversion
Chlorzoxazone variability
Cholesterol analysis LCMS
Chosing method for the calculation of AUC using WinNonlin
CI and BE - FDA guidance
Ciprofloxacin dosing
Citalopram fraction unbound
Clearance calculation from in vitro metabolic stability study
Clopidogrel analysis
Cmax in BE
Column change
Computer Program - Microsomal data to human clearance
Concentration in the predose sample
Correlation of Microsomal assay with invivo metabolism of compounds
Coumarin metabolite information
Creatinine Clearance in Chinese or other ethnic groups
CV of anagrelide
CV of lamivudine
CYP inhibition assays
CYP2C8 mediated drug metabolism in animal models
Data Input in WinNonlin for Metabolite Kinetics
DCGI renewal
Deconvolution tools WinNonlin
Decreasing trend in assay response
Definition of ECe50
Degraded by phosphoramidase
Design of Biostudy
Design of MPA study
Desloratadine BE
Details for Cholecalciferol - Vitamin D3
Determining blood to plasma ratio
Diclofenac CV
Diclofenac dissolution
Difference between 505b(2) and suitability petition
DiffusiMax - transdermal delivery
Digoxin assay
Diltiazem LCMS analysis
Dissolution media for Amlodipine besilate tablets
Dizocilpine behavioural studies
Does half-life in blood inform about drug targets
Does this combination requires a BE study
Donepezil HCl BE Study
Dose for linearity, non-linearity
Dose proportionality
Dose schedule of humanized monoclonal antibody based on half-life
Dose selection for drug-drug interaction
Dose selection for tolerance study
Dosing strategy for mAbs
Dosing times
DPD activity
Drug drug interactions
Drug-drug interaction
Efavirenz CV
Effect of cross-linking on dissolution
Efficient presentation of complex data
Ellagic acid bioanalytical method in human blood
Enalapril maleate
Endothelium, Blood Vessel, or Capillary Surface Area
Enoxaparin PK PD
Enteric coated capsules
Enterohepatic reabsorption half-life
Enzymatic or transport modulation after single dose
Eplerenone BCS classification
Equations for competitive antagonism model
European guidelines for bioequivalence studies
Examples of palatability questionnaires for oral suspensions
Exclusion of points in the calibration curve
Extended CC range
Extraction of Amphotericin B in biological sample
Extraction of Ellagic acid from blood
Extraction of polar basic drugs, pyrazinamide ethambutol, isoniazid
Extraction of Zanamvir
Extrapolation in Bioequivalence studies
Fasted-state BA-BE study
Fenofibrate - highly variable drug
First dose kinetics concept
FiveSix nephrectomy procedure in rats
Fix only some parameters in WinNonLin
Fluoxetine
Food effect study - same drug different formulations
Free Analysis Research Tool for Sample Size Iterative Estimation
Free or unconjugated
Fresh Calibration Curve for Stability exercise in Validation
GCP Query
Generic BE Study Phase
GFR vs AUC for metabolized drug
Group effect in BE study
Heaviside function in NONMEM
Hepatic blood flow - Gottingen minipigs
Hepatic extraction question
Hepatocellularity in Monkey
High biliary clearance compound
High parameter CV
How to deal with a sequence effect
HPLC assay for paracetamol, ibuprofen and caffeine
ICH E3 compliance e-CTD reports
ICH format for ANDA submissions
Imaging MS in drug development
Importance of Time Zero Samples
In vitro dissociation rates
Including zero hour data
Incurred sample analysis
Indium excretion
Inter and Intra Subject Variability, QTc
Intercept and LLOQ
Interference in blank plasma
Internal standard in Caco-2
Intra-subject variability
Intracellular nucleoside triphosphate half-life
Intrauterine Drug Delivery
Intrinsic clearance of testosterone and hydroxycoumarin
Invitro-Invivo-correlation
IP injection of fenofibrate
IP vs PO bioavailability question in rat
IR Vs SR comparative Oral Bioavailibility Fasting
IV dose PEG400 DMSO
IVIVC
LC-MS-MS methodology for DESLORATADINE
Limit for blood withdrawal
Locally Acting Drugs in GI
Low pH collection tubes
Mannitol HPLC protocol
Matrix selection - NCE
Meal consumption in a BA-BE study
Mercaptopurine BE
Mesalamine hplc
Metabolic profiling the best matrix
Metabolic stability in liver microsomes
Metabolism information of progestins in OC
Metabolism studies in GLP or in spirit of GLP
Metabolite found in bile but not in vitro
Metabolite intermediate complex
Metabolized by 2D6 in vivo
Method for Gestodene
Method for Goserelina
Method validation
Mice Vs Dog - Blood Brain Barrier
Michaelis-Menten inter-compartment exchange
Microsomal stability
Microsomes lipophilic compounds
Miglitol BE
Minimizing nonspecific binding in plasma protein binding experiments
Modeling Baseline Fluctuation in Indirect Reponse Models
Modeling or modelling
Modulus function
Monkey serum albumin
Monolix users
Morphine PD
Morphine tolerance model
Mouse hepatic microsomes
Mouse pharmacokinetics
Mouse vs rat concentration
Mucus Membrane Irritation test
Multiple attendee discount for WinNonlin training
NAT2 Specific substrate with available metabolite
Neurotransmitter assay
New agreement between ICONUS and POP-HARM regarding the PDx-MC-PEM program
Nicotine and Cotinine method validation
Non-compartmental analysis of urinary excretion rate data.
Non-GLP pre-clinical bioanalytical assay development for PK
Nonmem bootstrap-prediction error
Nucleoside triphosphate by LC-MS
Nucleotide analysis
Nucleotide invitro metabolism
Octanol/water partitioning
Old and new molecules
Olsalazine Bioanalytical method
Open-access triple quad
Orlistat absolute availability
P-glycoprotein polymorphism
p-gp deficient mice
Paliperidone inhibition constant
Parallel study design in BE study
PD comparison between route of administration
PEG400
PEG400 in monkeys
Percent Observance
Period and sequence affects
Permeability of Betahistine Dihydrochloride
Perphenazine analysis
Pgp assay
pH Solubility problem
Pharmacodynamics of breast tumor growth in placebo group
Pharmacodynamics of GABA
Pharmacokinetics in an CSR using ICH format
Pharmacokinetics of heroin
Pharmacokinetics of succinic acid
PK and ba or be
PK Doses
PK for Endogenous Substances - Fully Adjusted Background Model
PK for propofol
PK in double-blind clinical studies
PK in hepatic impaired population
pK of Gleevec
PK strain differences in rats - albino vs pigmented rats
PK Study in Mice
PK-PD modeling for tolerance
PK/PD modeling
PK/PD modeling in pre-clinical drug development
PLT Tools: A Graphical Interface for the NONMEM System
Pre-clinical studies for new salt form
Precipitation of plasma proteins
Preclinical Toxocology
Predicting Cp
Predose concentrations
Predose time and AUC
Pregnant volunteers during study
Problem with protein precipitation
Prodrug analysis
Proposed FDA Scaled BE Limits for HVDs: Effect on Sample Size Determination
Protein Variation
Protocols for preclinical pharmacokinetic studies
Pulmonary Clearance
Pusulfan
QC level for ANVISA study
Quantitation of Tizanidine
Radioactive drugs
Raised Pump Pressure
Rat GFR
Rat TK data for a 2D6 substrate
Recombinant isoenzymes VS PHLM
Recovery
Recovery calculation
Reduced absorption on repeat dosing
Reduced response with LC-MS-MS
Reinjection
Relative Contribution of CYP2C19 and CYP3A4 to Omeprazole 5-Hydroxylase Activities in HLM
Relevance of microsomal metabolic stability
Reliable t1/2
Renal clearance from pooled urine
Repeat analysis
Repeat Analysis of Clinical Samples
Replicate Design
Reporting Stability Data
Residual analysis - Test on normality
Retention for polar basic compounds
Revision of European BE-Guideline
Ritonavir dose
Role of K01 in biphasic elimination kinetics
S+ or R for NCA
S- ADAPT
S-Plus Table Example
SAAM II sampling losses
Safely storing bone marrow samples
Safety of the column
Salivation in preclinical toxicity studies
Sample pooling strategy
Sample size calculation for two-way crossover study
Sample size in parallel studies
Sampling from vein and artery
SAS for NCA
Saturable inter-compartment exchange
Sensitivity serum creatinine vs BUN in man
Separation of nanoparticle from plasma samples
Sequence and Period effects in BE study
Serial blood collection
Similarity of Dissolution Profiles
Simulated gastric - duodenal juice
Single dose animal study
Single pass intestinal perfusion study
Sodium metabisulfite and c18 column
Software with clinical applications
Solid phase micro extraction sampling
Solubility of Galactosylceramide
Solutol in tox studies
Solvents used in caco2 permeability studies
Specificity of plasma batches
Specificity Selectivity for ANVISA
Stabilization of tetrazole glucuronides
Starting PK analysis
Statistical model for Multiple group of subject in BE study
Steady state studies
Suitability petition versus 505b(2)
T1/2 beta and covalent binding
Teaching HPLC
Temocaprilat
Temperature parameter during Q1 scan
Terminal concentration difference between iv bolus and infusion
Terminal half life and elimination half life
Thiopental HPLC or FPIA
Thorough QT/QTc study
Tissue volume calculation
Tissues from infected rodents
Toxicological data for Tromethamine
Triplicate ECG's for QT
Tumor tissue sample preparation
Two compartment distribution
Two compartment PK
Two peaks in Cp curve
Two sites of absorption
Two way cross over
Two-compartment model and volumes of distribution
Two-compartment model CSF concentration
Two-compartment model distribution rate constant
UDPGT activity
Urinary excretion calculation
Ursodiol analysis
Validated statistical software
Value of drug-drug interactions in rats
Variable aspirin EC Cmax
Variation in RT of subject samples
Verapamil - pgp Inhibition
Vomiting and extended release
Water as IV vehicle
Weight adjusted Cmax and AUCs
Weighting factor
Welcome to the new website of MACNIS
What is Clinical Pharmacology
What is the "apparent" half-life
Wings for Nonmem
Wings for NONMEM error message
WinNonlin Data entry for Deconvolution of oral dose
WinNonlin error message
WinNonlin Operational SOP
WinNonlin SS and replicate study calculation
WinNonlin User defined three compartment model
WinNonlin user model help

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