Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5722_Библиотеки_им_академика_М_И_Перельмана.pdf
Index
349
Clinical Methodologies 258
Clinical Pharmacokinetics 7, 10, 11, 14, 27, 217, 218
Clinical Toxicology 7, 13
Clinical Trails 265
Clinician 233
Closed Column-Type System 304
closed fl ow-through dissolution apparatus 305
Closed-Compartment Dissolution Apparatus 300
Co-evaporates 325
Collection of Sample and Sampling Times 335
Colorants 116
Column Performances 339
Column type dissolution method 301
Column-Oven Temperature 342
Compartment in Parallel 141
Compartment in Series 141
compartment model variants 138
Compartment Models 136
Compartment 136
Complexation 308, 314
Complexing Agents 117
Composition 15
concentration gradient values 63
Concept of Absorption Window 66
conditioned-avoidance response apparatus 6
congenital abnormalities 42
Consequences of Enterohepatic Circulation 192
Controlled Release Product 45
Controlled Release 32
controlled-release formulation 219
Conventional Buffers for HPLC 341
co-precipitation method 324
Corticosteroid 131
covering material 314
CPY2E1-inducer 279
Criteria for the Design of Bioequivalence Study 328
Critical Absorption of Ionized (Polar) Drugs 98
critical diffusion 46
Critical Micelle Concentration (CMC) 318
Cross-Over Design 259
crossover study 16
cross-section of the paddle stirring element 303
cross-section of the stirring basket element 302
Crucial Presence of Aqueous Unstirred Diffusion
Layer 99
Crystal Growth Inhibitors 117
Curve-fi tting Technique 163
cyclodextrin molecule depicting an encapsulated
drug 326
CYP2D6 substrate 280
CYP3A4 substrate 280
cytochrome [CYP3A4] 279
cytochrome isoenzyme 279
D
Danckwert’s Model 83, 84
data-base for statistical analysis 330
decrease in ‘retention-time’ 341
degradation 297
degree of drug availability 297
Delayed Release 77
Delaying Absorption until Reaching Intestines 313
Demerits of Multiple-dose Bioequivalence
Studies 329
Dermatitis 194
design and applicability of the drug product 78
Design and Conduct of Bioequivalence Studies 327
Design of Dosage Regimens 221, 222
Determination of Lipoidal Solubility of a Drug 96
Determination of Pharmacokinetic Parameters 235
Determination of Plasma Volume 171
determining appropriate conditionalities 306
Development of HPLC Method 342
development of IVIVC 31
Deviations from the pH-Partition Hypothesis 101
Deviations 201
Devoid of Data-Fitment in Perfusion Model 150
Diagrammatic representations of AUMC
and AUC plots 153
Dialyzate Flow 239
Diazepam Binding Site 127
Diffusion Layer Model 83, 84
Digitoxin Binding Site 127
Diluents 112
Direct Linear Plot 205
Disadvantages of Latin-Square Design 263
Disease conditions 218
Disintegrant 75, 105, 114
Disintegrating Agents 114
Disintegration Time 106
Disintegration 74, 297
dissolution and disintegration tests 298
Dissolution Fluids 299, 300
dissolution of drug substance 30
dissolution phenomenon 78
dissolution rate of tablets 110
Dissolution Testing 30
Dissolution 75
Distribution Equilibrium 140
distribution profi le 28
Index
350
Distribution 26
dosage form 7
Dosage Regimens 21, 221
Dose Size 222, 224
dose–response relationship 26
Dosing Frequency 223, 224
dosing interval 223, 226
Drug Absorption vis-à-vis Patient-Related Factors 117
Drug Absorption vs. Bioavailability 72
Drug Absorption 63, 275
drug administered via a single oral dose 156
drug administration 26
Drug concentration 217
drug diffusion 63
Drug disposition 21
Drug Dissolution Rate and Bioavailability 298
Drug distribution 21
Drug Dosing in Elderly Patients 240
Drug Dosing in Hepatic Disease 240
Drug Dosing in Renal Disease 241
Drug Elimination by Capacity-limited
Process 201
drug formulations 285
Drug in Dosage Form 5
drug metabolizing isoenzyme systems 279
Drug Monitoring and Drug Therapy 245
drug plasma concentration 9
Drug Price Competition (DPC) 327
Drug Product with a High Water Solubility 45
Drug Product 287
drug responses 218
drug solubility and dissolution rate 79, 80, 81
Drug–drug interactions 218
drug–food interactions 219
drug-fraction excreted unchanged 177
Drug–Protein Binding Complex 124
drug-protein binding phenomena 312
drug-protein binding 241
Drugs Excreted via Saliva 194
Drugs with Diverse Chemical Properties 194
Drugs with High Therapeutic Index 232
dynamic equilibrium 25
E
effective diffusion 46
Electric Water Bath 304
Electrochemical Diffusion 69
Elicitation of Therapeutic Effect 249
elimination constant 163
elimination half-life 226
elimination mode 28
Elimination Phase 21, 157
elimination rate constants (KE) 154, 196, 227
Elimination 21, 26, 200
emanated secretions 48
EMEA 264
Enantiotropic Polymorph 88
Endocytosis 42, 70
Endogenous Materials 131
Endogenous Substances 126
endothelium capillary 41
enteric coated aspirin tablets 310
Enteric Coated Multiple Unit Dosage Form 32
Enteric Coating Preparations 314
Enteric-Coated Tablets 77
Enterohepatic Circulation of Bile Salts 191
Enterohepatic 191
Environmental factors 218
enzymatic stability 312
erythrocyte/plasma concentration ratio 132
Erythrocytes 125, 131
Estimation of AUC from Blood/Plasma Level
Equations 255
Estimation of C
max
and t
max
168
Ethical Considerations 258
Eutectic Mixtures 322
Evan’s Blue 171
Exceptions 201
excretion and absorption rate constants 177
Excretion Rate Method 180
Excretion via Milk 189, 195
Excretion via Saliva/Skin 189, 194
Exemptions in Bioequivalence Study 267
Exhalation 189, 193
Experimental Group Patients 245
Exponential Phenomenon 55
Extent of ‘drug absorption’ 333
Extent of Drug-Protein Binding 128
Extra Column Volume 343
Extra Hepatic/Non-renal Elimination 189
extracellular compartments 45
extracellular fl uid (ECF) 237
Extravascular Administration 6
extravascular route 6
extremely low solubility 316
F
Facilitated Diffusion 67
Factors Governing Retention Time–
Sensitivity–Selectivity 338
Index
351
Factors Infl uencing Drug Absorption 43
Factors Infl uencing Haemodiazability of a Drug 238
Factors that Decrease Bioavailability 308
Factors that Increase Bioavailability 315
Fast Disintegration 75
fat-soluble vitamins 115
FDA Defi nition for IVIVC 31
FDA-Classifi ed Therapeutically Equivalent Dosage
Forms 290
Features of Passive Diffusion 60
Fick’s fi rst law of diffusion 59
Fillers 112
Film Theory 83–85
First Trimester 42
First-Order Absorption Rate Constant 158
fi rst-order elimination 177
First-Order Kinetics 199
fi rst-pass effect 31
fi rst-pass metabolism 309
fi rst-pass via the liver 291
Flow Models 147
Flucocinolone 316
Fluorocuracil 211
Fluid-Energy Mill 317
Fluid-Mosaic Model 50
Foecal Excretion 189, 193
Foetal Membrane 41
foetal trophoblast basement membrane 41
Food-Effect Bioavailability (BA)/Bioequivalence (BE)
Study 334
formulated product 7
Formulation Factors 103
Formulation of Clinical SOPs 266
formulation optimization 317
Four-way cross-over design 262
free drug concentration of certain ‘drugs’ in plasma 132
Fried’s rule 237
G
Gastric Emptying Rate 57
gastric emptying time 80
Gastric Emptying 54, 57
gastric instability profi le 314
gastric stability 312
gastrointestinal (GI) components 80
gastrointestinal (GI) hydrolysis rates 273
gastrointestinal (GI) pH 80
Gastrointestinal (GI) Physiology 47
Gastrointestinal Blood Flow 51
Gastrointestinal Motility 57
Gastrointestinal pH 51, 52
Generalized Approach 335
generated bioequivalence data 328
Generic Drug Products 17
Generic Drug 249, 285, 328
Generic Nomenclature 288
generic product 327
Generic Substitution 288
Genesis of IVIVC 31
Genetic infl uence 218
Genetic Polymorphism and Drug Interactions 280
GI functions 331
GI physiology 45
GI tract 118
Glass Dispersions 325
Glass Solution 321
Glass Suspensions 325
Globin 132
Globulins (a-, b-, g-Globulins) 131
globulins 125
glomerular fi ltration rate (GFR) 237
Glutathione 279
Good Clinical Practices (GCPs) in
Bioequivalence 265
Good clinical practices [GCPs] 265
Granulation Var iables 108
Graphical Representation of Michaelis–Menten
Equation 199
griseofulvin 115
griseofulvin–succinic acid 321
Guard Columns 340
Guidelines for Equivalence Studies 19
H
Haematocrit value 266
Haemodialysis 238
Haemoglobin 132, 266
Haemoperfusion Method 239
Half-Value Duration (HVD) 252, 257
Hanes–Woolf Plot 204
Helsinki declaration 297
Hematocrit 172
Hepatic Clearance 187, 196
high density lipoproteins (HDL) 130
Highlights of Polymorphs 88
Highlights of Pore Transport 63
Highlights of SOPs 266
HPLC 304
human gastrointestinal (GI) tract 48
human serum albumin (HSA) 124, 126, 129
Index
352
human-gastric fl uid 314
hydrated drugs 319
Hydrophilic Substituted Drugs 61
hydrophobic drugs 86
hydrostatic pressure 63
I
Identifi cation of Non-competitive Enzyme
Inhibition 204
Identifi cation of Uncompetitive Enzyme
Inhibition 204
Implication of Henderson and Hasselbalch
Equation 62
Importance of Cytochrome Isoenzymes 278
Importance of GI pH 52
Importance of Monitoring Drug Therapy 246
Importance of Pharmacokinetic Models 134
important sites of drug absorption 118
In vitro Dissolution Technique 299
In vitro–In vivo Correlation (IVIVC) 30
Incomplete Bioavailability 76
increase the ‘shape of peak’ 341
increased drug availability 241
independent-model method 151
Individualization 235
Individualized Lidocaine Infusion Rates 244
Indocyanine Green 171
industrial pollutants 218
infl ammatory conditions 316
Infl uence of dissolution rate 78
Information Included in SOPs 266
Innovator Medicinal Product 331
insoluble granules 57
Instability 308
Instrument to Be Used 338
Interactions Affecting Metabolism 278
Interactions Affecting Renal Excretion 281
Interactions Changing Drug Distribution 278
Interfacial Barrier Model (or Double Barrier or
Limited Solvation Theory) 84
Interfacial barrier model 85
International Union of Pure and Applied Chemistry
(IUPAC) 287
Intestinal Excretion 189, 194
intestinal mucosa 50
intestinal transit time 80
intestinal transport 29
intracellular compartments 45
intracellular fl uid (ICF) 36
intraperitoneal route 16
Intricacies of Bioequivalence 249
Intrinsic pharmacologic activity 6
intrinsic solubility 83
Investigation of Characteristic Features 333
Ion Pairing Agents 341
Ionic Diffusion 69
ionized drug molecules 38
Ionized Drugs 36, 61
Ion-Pair Transpor t 69
iontophoretic-release formulation 219
Isoenzymes 278
Isoproterenol 4
IVIVC Utilization 32
K
KADME 21
Kinetics of Urinary Excretion 177
L
lamellar segment 34
Large intestine 118
Latin-Square Cross-Over Design 261
Latin-square design 262
Layer Model 85
LC-MS vs. HPLC 342
Limitations of pH-Partition Hypothesis 97
line of identity 57
linear pharmacokinetics 269
linear relationship 25
Lineweaver–Burk Plot (or Doubled-Reciprocal
Plot) 202
Lipoidal Barrier 38
Lipophilic 61
Lipophilicity and Absorption of Drug 96
lipophilicity of a drug 80
Lipophilicity 70
Lipoproteins 124, 125, 129
Lithium (Li) Excretion 281
liver transplants (LTs) 243
Liver 118
Loading and Maintenance Doses 230
log linear segment 163
Loo–Riegelman and Wagner–Nelson
Equations 160
Loo–Riegelman Equation 160, 162
low biliary clearance 194
low density lipoproteins (LDL) 130
low rates of metabolism 194
low renal clearance 194
Lubricants 105, 114
Index
353
M
maintenance dose 228
mammillary compartment models 139
Mammillary Model 137
Manufacturing aspects 28
manufacturing protocols 317
Mean Absorption Time (MAT) 252, 256
Mean Residence Time (MRT) 252
MEC: Minimum effective concentration 11, 20
Mechanism of Dihydropyridine 39
Mechanism of Gastric Emptying 54
Mechanism of GI-Blood Flow 52
Mechanisms of Drug Absorption 58
Mechanisms of Molecular Dispersions 322
membrane permeability 29
Merits and demerits of compartment
modelling 148
Merits of Non-compartmental
Pharmacokinetics 153
Merits of Physiologic–Pharmacokinetic
Models 151
Metabolic Enhancement 279
Metabolic Inhibition 280
Metabolites 26
Metastable Polymorphs 319
Method of Residuals 144
Method Validation 345
Methods of Data Analysis 307
Micelle 115
Michaelis–Menten Equation 196, 197
microclimate pH 101
microcrystalline soluble aspirin tablets 310
Micronization of drug particles 86
Micronization 317, 318
Microstructures of Certain Eutectic Mixtures 324
microstructures of eutectic mixtures 324
miniaturized USP18 basket apparatus 305
minor formulations 33
mixed crystals 320
Mixed-Order Kinetics 199
model development 10
Molecular Dimension 239
molecular dispersions 320
Molecular Encapsulation 326
Molecular Inclusion Complexes 326
molecularly encapsulated drug 326
Monotropic Polymorph 88
morphologic variance 48
Mosteller’s equation 237
MSC: Maximum safe concentration 20
MTC: Minimum toxic concentration 11, 20
Mucins 70
mucoadhesive-release formulation 219
multi-compartment models 230
Multi-compartment Properties 140
Multiple Dosing Profi le 227
multiple-dose studies 329, 333
Multiple-Dose Study vs. Single-Dose Study 328
multiple-dosing system 226
N
Narrow therapeutic index 232
Nasal Drug Delivery System (NDDS) 32
Naturals, synthetic and semi-synthetic polymeric
materials 112
Negative Disintegration 75
Negligible solid–solid solubility 322
New Dosage Regimen Designing 236
Nitroglycerine 209
Non-aqueous binders 113
non-average complications 10
Non-compartmental Pharmacokinetics 151
non-ionizable drugs 313
Non-linear absorption profi le 195
Non-linear distribution pattern 195
Non-linear elimination trend 195
Non-linear Pharmacokinetics 154, 195
Nonsink Conditions 299
normal drug molecules, lipophilic drugs 36
Normal Healthy Adult Volunteers 330
Normal Phase Columns 339
Normalized C
max
252
Novel Dosage Forms 32
Noyes–Whitney Dissolution Rate Law 78
Number and Shape of Compartments 137
Number of Compartments 137
Number of Volunteers Taken in a Study 260
O
Observed Positive Deviation from Linearity 309
ocular-release formulation 219
one-compartment open model kinetics 230
open two-compartment pharmacokinetic model 141
Optimal Multiple Dosage Regimen 221
Optimal Single Dosage Regimen 221
optimized bioavailability 220
Oral Drug Absorption 43
Oral Multiple Dosing Regimens 227
oral-trans-mucosal-release formulation 219
Orange Book 286
Index
354
Organic Acidic/Basic Drugs 194
Organ-specifi c Clearance 173
osmotic differences 63
Overcoming Acute Bioavailability Issues 315
P
Packing of Capsule Contents 111
paddle-type dissolution apparatus 303
Paracellular Drug Absorption 58
Parallel Design 259, 261
parameterization 10
Parameters of Blood Analysis 266
parent drug 319
parent formulation 14
Parkinsonism 39
partially ionized drug molecules 38
Particle Size and Drug Absorption 81, 86
particle size and effective surface area 79
partition coeffi cient values 63
Partition coeffi cient 60
passage of blood via GIT 80
passive diffusion processes 64
passive diffusion transport process 65
Passive Diffusion 59
Patent Term Restoration Act (PTRA) 327
Pathophysiologic Status 150
Pathophysiological Parameter 37
Pathways of Drug Absorption 47
Patient’s Maintenance Dose 240
Patient-Related Factors 79
Peak heights 307
Peak plasma concentration 21
peak plasma level 21
Peak-Height Concentration 295
PEG-6000 113
penetration of dissolution fl uid 318
Penetration/Surface Renewal Theory 83–85
Percentage swing 252, 257
Peripheral Compartment 141–144
Peritoneal Dialysis 239
Permeability 30
Permeation Profi le of Cationic Drug Molecules 69
pH of Mobile-Phase Buffer 341
Pharmaceutic Approach 316
Pharmaceutic Ingredients 111
Pharmaceutical Alternatives 288
Pharmaceutical Equivalent 289
Pharmaceutical Factors 73, 79
Pharmaceutical Substitution 289
pharmaceutics domain 9
Pharmaceutics 103
Pharmacodynamic and pharmacokinetic factors 28
pharmacodynamic criteria 218
Pharmacodynamic Interactions 281
Pharmacodynamic Monitoring 246, 247
pharmacodynamic studies 298
Pharmacodynamic 7, 12, 27, 31, 217
Pharmacokinetic Drug Interaction 275
Pharmacokinetic Interactions 275
Pharmacokinetic Means 315
pharmacokinetic modelling 133
Pharmacokinetic Models vis-á-vis Mathematical
Models 135
Pharmacokinetic Models 133, 135
Pharmacokinetic Monitoring 246, 247
Pharmacokinetic Parameters of a Drug 183
pharmacokinetic principles 218, 219
pharmacokinetic two-compartmental model 136
pharmacokinetics domain 9
Pharmacokinetics of Drug Absorption 154
pharmacokinetics parameter 10
pharmacokinetics 7, 8, 10–12 27, 31,
123, 134, 217
pharmacokinetics–pharmacodyanamic model 13
pharmacologic activity profi le 3
pharmacologic or clinical pharmacokinetic response 5
Pharmacologic Response 5
pharmacologic test apparatus 6
Pharmacological activity profi le 217
Pharmacological Antagonism 282
pharmacological response 12
Pharmacological Synergism 282
Phase Rule 323
pH-Partition Hypothesis 89
Physicochemical Characteristics of a Drug 317
physiologic pharmacokinetic model of drug
perfusion 149
physiological effect 12
Physiological factors 28
Physiological Surfactants 115
Physiologic–Pharmacokinetic Models) 147
Pinocytosis 47
Piperacillin Sodium 212, 214
pK
a
of a drug and its Ph 80
Placental Barrier (PB) 33, 40, 42
plasma clearance factor 154
Plasma Drug Level–Time Curve 156
plasma half-life 196
Plasma Peak Trough Fluctuation 252, 253
Plasma Protein Drug Concentration Measurement 124
Index
355
plasma protein 124
plasma–drug concentration levels 11
plasma–drug concentration 20, 218, 227
plasma-drug concentration–time profi le 154, 224
Plateau Phase 157
Plateau Time (PT) 252, 256
Plot Variants in Non-linear Pharmacokinetics 202
Polymorphic Crystals, Solvates and Drug
Absorption 81, 88
polymorphism and amorphism 79
polyvinylpyrrolidone (PVP) dispersions 325
poor GI absorption rate 316
population averages 10
Pore Transport (Convective Transport) 62
Possibility of Extrapolation 150
Post-absorption Phase 21, 157
Potential solubilizer 113
Precompression Method 109
Precursor-Type Prodrug 317
Predictions from the pH-Partition Hypothesis 93
Predictor of Dissolution–Rate-Limited
Absorption 75
Preferential Adsorption on Insoluble Carriers 320
Preferred Model for Analysis of Data 135
Preparation of Buffers for HPLC 341
Preparation of Solid Solution 321
Presystemic Metabolism 80, 308, 309
preventing pH 48
Procainamide Hydrochloride 208
Procedure for Regeneration of HPLC Column 340
process changes 33
Process Parameters 299
Process Technique Adopted 15
procreative-powered renal-secretion mechanism 13
Prodrug of Erythromycin 314
Prodrug of Fluclorolone 316
Product Form Characteristics 103
product quality 328
Product with Very Poor Aqueous Solubility 45
progress in IVIVC 31
Prolonged Release 77
Prompt gastric emptying 54
prothrombin-clotting time 11
pruritic conditions 316
Pseudopolymorphism 80, 319
Pump Effect 300
Pyloric Sphincter 277
Q
Quantifying Relative Availability 16
R
Rapid absorption and independent of GI pH 94
rapid dissolution 82
rate constant [fi rst order] 15
Rate of ‘drug absorption’ 333
Rate of Dissolution 97
rate of drug availability 297
Rate of Drug Dissolution and Absorption 105
Rate of Permeability 97
rate of reaction 201
Rate-Determining Step (RDS) 44, 73
Rate-Limiting Step (RLS) 44, 76, 81
Rates of absorption 307
recommended therapeutic concentrations 124
rectal route 16
Rectum 118
Red Blood Cells (RBCs) 125, 131
reduced drug-metabolizing enzymes 241
reduced hepatic clearance 241
ree drug concentration present in the plasma 132
Reference and Test Product 331
Reference Listed Drug (RLD) 289
Reference Product 331
reference standard 305
Relative Bioavailability 292
Relative Humidity 336
renal blood fl ow 237
Renal Clearance 175
renal functions 331
Retention of Test and Reference Product 334
Reverse Phase Columns 339, 340
Role of Sinusoidal Capillaries 36
Rotating Basket-Type Dissolution Apparatus 300
Rotating Paddle-Type Dissolution Apparatus 303
route of administration 6
S
Salient Features of Pharmacokinetics 8
Salts of Drugs 319
Sample Injection Volume 343
SC route 16
scientifi c principles 5
Scope of Biopharmaceutics 7
Scope of Pharmacokinetics 219
Sedimentation 266
Selection of Drug Product 287
Selection of GC/HPLC Column 339
Selection of Statistical Methods 306
semi-log plot 155
separation of components 344
Index
356
Sertoli Cell 43
Serum Albumin 125, 126
Serum bilirubin level 267
Serum Ca
2+
concentration level 267
Serum creatinine 267
Serum K
+
concentration level 267
Serum Na
+
concentration level 267
SGOT [Serum Glutamate Oxaloacetate Amino
transferase] 267
SGPT [Serum Glutamate Pyruvate Amino
transferase] 267
Shape of Compartment 137
shape of peak 344
short plasma half-life 232
Sigma-Minus Method 180, 181
Silica Columns 340
simple diffusion phenomenon 41
simple eutectic system 323
Simple Mono-exponential Process 55
Single Dose Bioequivalence Study 248
single-dose studies 333
Sink Prameters 299
sleep-producing tubules 42
Small intestine 118
solid dispersion method 325
Solid Dispersions 88, 324
Solid Solution 87, 320
Solute–Solvent Complexation 319
Solvates and Hydrates 89
Solvent Deposition 320
solvent method 324
some weakly basic drug substances 49
specialized absorption phenomenon 66
Specifi c Composition of Mobile-Phase 342
Specifi c Presence of Virtual Membrane pH 97
speed of dissolution 297
Spray Dryer 317
stability of drug 80
Stability 15
Standard Dose Form 293
Standard Dose 292
Statistical Analysis 307
Statistical Interpretation of Bioequivalence Data 308
Statistical Method Variants 261
Statistical Methods for Bioavailability Studies 306
Statistical Methods in Bioequivalence Study 261
Statistical Methods 306
Statistical Moments Theory 152
Steady-State Studies 328
Stereochemistry 31
steroidal drugs 115
Stomach 119
Study Conduct 334
Study Design 258
Study Objective 258
Study Population 258
Subjects (or Volunteers) 330
Substances Excreted via Biliary Excretion 190
Supplementary Analytical Instruments 337
supramolecular-release formulation 219
Surface-Active Agents 318
Surfactants 115, 318
Suspending Agents 105
Sustained Release 32, 77
Switchability 248
Systematic Collection of SOP-Data 266
systemic availability 291
Systemic Drug Absorption: Excipients 105
T
tableting process 110
Tamoxifen Binding Site 127
target-drug concentration 28
targeted-release formulation 219
teratogenic effects 42
Test Dose Form 293
Test Dose 292
Testing Models: For in vitro Dissolution
Technique 299
Thaw-Melting Temperature 324
The Dissolution Equipment 299
The Drug Dissolution Estimation Apparatus 300
Theories of Drug Dissolution 80, 83
therapeutic actions 25
Therapeutic Alternatives 290
Therapeutic Drug Monitoring 11
Therapeutic Endpoint 245
Therapeutic Equivalents 290
Therapeutic Index 219, 232
Therapeutic Monitoring 246
Therapeutic Objective 220
therapeutic response 25
Therapeutic Substitution 291
Therapeutic Window 222
therapeutically equivalent 298
Three-way cross-over design 262
Time Above the Average Concentration
(T
above
C
avg
) 252, 257
Time interval 19
Time-dependent Pharmacokinetics 154
Index
357
Time-released formulation of theophylline 220
total body surface area (TB SA) 237
total body weight (TBW) 237, 238
Total cholesterol 267
total clearance 174
Total protein 267
Toxic Endpoint 246
toxic response 12
Toxicokinetics 7, 13
Toxicological response 217
Transcellular Absorption 58
Transcellular Diffusion of Polar Molecules 50
Transcortin 131
transdermal-release formulation 219
Transmitted Drug Delivery System (TDDS) 32
trapezoid rule 274
Trapezoidal Rule 163, 254
two-compartment open mode 160
Two-Period Crossover Design 329
Two-way cross-over design 262
U
ultimate hepatic blood fl ow 241
unabsorbed food residues 57
unavoidable enzyme activity 54
unbound drug substance 26
Uncomplicated Drugs 19
Unifying Hypothesis 101
United States-Food and Drug Administration
(US-FDA) 286
Urinary Drug Amount–Time Profi les 294
Urticaria 194
US FDA 29
Usage of ‘solid dispersions’ 320
Use of C-loaded columns 340
Use of Radioactive Labelled Molecules 333
US-FDA and EMEA: comparison of the regulatory
requirements 265
US-FDA Guidance for Industry 30
US-FDA Requirements 288
US–FDA 7, 14, 29, 264
US-FDA/EMEA Regulatory Requirements for
Bioequivalence Studies 264
Utility of ‘eutectic mixtures’ 320
Utilization of ‘solid solutions’ 320
V
Vancomycin 141
variability in pharmacokinetics 218
Variants in AUC Value 270
Variants in Bioavailability Studies 248
Variants in Biopharmaceutics 7
various disease conditions 80
Vascularity 137
Vd: Volume of distribution 15
Vehicles 113
Venous Equilibrium Model of Hepatic
Clearance 187
very low density lipoproteins (VLDL) 130
Volume of Distribution (Vd) vs. Protein/Tissue
Binding of Drugs 172
Volume of Distribution (Vd) 170, 196
Volume of Distribution and Distribution
Coeffi cient 170
Volume of Distribution 143
Volume of Total Body Water 172
W
Wagner–Nelson Equation 164
Wagner–Nelson method 167, 168, 184
Warfarin (or Azapropazone) Binding Site 127
Washout Duration 334
Washout Period 260
Water/Food Intake of Subjects
During Phase 335
WBC count 266
Weak-Electrolyte Drugs 61
weakly acidic drug substances 49
Weakly Acidic Drugs 53
Weakly Basic Drugs 53, 313
Wet Granulation Method 108
Whole Plasma 26
Wide Variance in pH of gastric juice 53
Wilkins, New York, 2004 294
wonder drugs 327
Woolf–Augustinsson–Hofstee Plot 205
X
xanthine oxidase 316
Y
Young’s Rule 221, 237
Z
Zero-Order Absorption Rate Constant 155
zero-order and fi rst-order absorption
phenomena 155
Zero-Order Kinetics 167, 199
7KLVSDJHLQWHQWLRQDOO\OHIWEODQN