RT Book, Section A1 Shargel, Leon A1 Yu, Andrew B.C. SR Print(0) ID 1117895709 T1 Glossary T2 Applied Biopharmaceutics & Pharmacokinetics, 7e YR 2016 FD 2016 PB McGraw-Hill Education PP New York, NY SN 9780071830935 LK accesspharmacy.mhmedical.com/content.aspx?aid=1117895709 RD 2024/03/29 AB Table Graphic Jump Location|Download (.pdf)|Print1A, B, CPreexponential constants for three-compartment model equationa, b, cExponents for three-compartment model equationαProbability of making a type 1 errorβProbability of making a type 2 errorα, β, γExponents for three-compartment model equation (equivalent to a, b, c above)λ1, λ2, λ3Exponents for three-compartment-type exponential equation (equivalent to a, b, c above; more terms may be added and indexed numerically with λ subscripts for multiexponential models)Delta (Δ)Delta is sometimes referred to as the “effect size” and is a measure of the degree of difference between tested population samplesμ0The null hypothesis value for the meanμaμa is the alternative hypothesis value expected for the meanϰ2Chi-square testA or AbAmount of drug in the body of time t; see also DBAb∞Total amount of drug in the bodyABCABC transport proteinABWAverage body weightAEAdverse eventANCOVAAnalyses of covarianceANDAAbbreviated New Drug Application; see also NDAANOVAAnalysis of varianceAPIActive pharmaceutical ingredientARAbsolute riskARIAbsolute risk increaseAUCArea under the plasma level–time curve[AUC]∞0Area under the plasma level–time curve extrapolated to infinite time[AUC]t0Area under the plasma level–time curve from t = 0 to last measurable plasma drug concentration at time tAUMCArea under the (first) moment–time curveBABioavailabilityBCSBiopharmaceutics Classification SystemBDDCSDrug disposition classification systemBEBioequivalenceBioRAMBiopharmaceutics Risk Assessment RoadmapBLABiologic license applicationBMBiomarkerBMIBody mass indexBRCPBreast cancer-resistance protein (an ABC transporter)BUNBlood urea nitrogenCConcentration (mass/volume)CaDrug concentration in arterial plasmaC∞avAverage steady-state plasma drug concentrationCc or CpConcentration of drug in the central compartment or in plasmaCcrSerum creatinine concentration, usually expressed as mg%CEClinical endpointCeffMinimum effective drug concentrationCGIConcentration of drug in gastrointestinal tractCIConfidence intervalCmMetabolite plasma concentrationCmaxMaximum concentration of drugC∞maxMaximum steady-state drug concentration; see also CssmaxCminMinimum concentration of drugC∞maxMinimum steady-state drug concentration; see also CssminCpConcentration of drug in plasmaC0pConcentration of drug in plasma at zero time (t = 0) (equivalent to C0)C∞pSteady-state plasma drug concentration (equivalent to Css)CpnLast measured plasma drug concentrationCssConcentration of drug at steady stateCssavAverage concentration at steady stateCssmaxMaximum concentration at steady stateCssminMinimum concentration at steady stateCtConcentration of drug in tissuecGMPCurrent Good Manufacturing PracticesCKDChronic kidney diseaseCLTotal body clearance; see also ClTClCrCreatinine clearanceClDDialysis clearanceClhHepatic clearanceClintIntrinsic clearanceCl′intIntrinsic clearance (unbound or free drug)ClnrNonrenal clearanceClRRenal clearanceClURRenal clearance of uremic patientClTTotal body clearanceCOX-1Cyclo-oxygenase-1CQACritical quality attributeCMCChemistry, manufacturing, and controlCRFCase report formCRFACumulative relative fraction absorbedCvDrug concentration in venous plasma%CVPercent coefficient of variationCYPCytochrome P-450DAmount of drug (mass, eg, mg)DAAmount of drug absorbedDBAmount of drug in bodyDEDrug eliminatedDGIAmount of drug in gastrointestinal tractDLLoading (initial) doseDmMaintenance doseDNADeoxyribonucleic acidDNNormal doseDPDrug in central compartmentDtAmount of drug in tissueDuAmount of drug in urineD0Dose of drugD0Amount of drug at zero time (t = 0)EExtraction (extraction ratio)EPharmacologic effectEIntercept on y axis of graph relating pharmacologic response to log drug concentrationeGFREstimate of GFR based on an MDRD equationEmaxMaximum pharmacologic effectE0Pharmacologic effect at zero drug concentrationEC50Drug concentration that produces 50% maximum pharmacologic effectELSExtended least squareEMAEuropean Medicines Agency (http://www.ema.europa.eu/ema/)ERExtraction ratio (constant equivalent to Eh)FFraction of dose absorbed (bioavailability factor)fFraction of dose remaining in the bodyfeFraction of drug excreted unchanged in urinefuUnbound fraction of drugFDAUS Food and Drug Administrationf(t)Function representing drug elimination over time (time is the independent variable)f ′(t)Derivative of f(t)GFRGlomerular filtration rateGIGastrointestinal tractGMPGood Manufacturing PracticeHoThe null hypothesisH1The alternative hypothesis[I][I] is the inhibitor concentration in an enzymatic reactionIBWIdeal body weightICHInternational Conference on Harmonisation (http://ich.org/)IVIVCIn vitro–in vivo ...