Index. E Early exposure, 15, 33, 165, 166, , 177, 181, 183, 184 Enantiomers, 46 47

Transcription

1 Abbreviations AAPS ABE ACAT ADAM AEs AMA AMP ANDAs ANOVA AOA APCI API APSD ASEAN AUC AUEC BA BCS BDDCS BE CAT CFR CHMP CI C max CoA COPD CSF CTP American Association of Pharmaceutical Scientists Average bioequivalence Advanced compartmental absorption and transit Advanced dissolution, absorption, and metabolism Adverse events American Medical Association Adenosine monophosphate Abbreviated new drug applications Analysis of variance Administration on aging Atmospheric pressure chemical ionization Active pharmaceutical ingredient Aerodynamic particle size distribution Association of South East Asian Nations Area under the curve Area under the effect time curve Bioavailability Biopharmaceutics classification system Biopharmaceutics drug disposition classification system Bioequivalence Compartmental absorption and transit Code of Federal Regulations Committee for Human Medicinal Products Confidence interval Peak plasma concentration Certificates of analysis Chronic obstructive pulmonary disease Cerebrospinal fluid Child-Turcotte-Pugh L.X. Yu and B.V. Li (eds.), FDA Bioequivalence Standards, AAPS Advances in the Pharmaceutical Sciences Series 13, DOI / , The United States Government

2 460 Abbreviations CV DDIs DEPC DESI DMD DMPC DMPG DOPC DPI DPK DPPG DR EAEC ED50 EDTA ELISA EMA ESI ETEC FDA FEV1 FFD&C Act FPM GABA GE GI GIT GMR GSD HE HHS HILIC HPA HPLC HPMC HSPC HV HVDs IBE ICS INDs INR IR IS ISR Coefficient of variation Drug drug interactions Dierucoylphosphatidylcholine Drug efficacy study implementation Dermal microdialysis Dimyristoyl phosphatidylcholine Dimyristoyl phosphatidylglycerol Dioleoylphosphatidylcholine Dry powder inhalers Dermatopharmacokinetics Dipalmitoylphosphatidylglycerol Delayed release Enteroaggregative E. coli Median effective dose Ethylenediaminetetraacetic acid Enzyme-linked immunosorbent assay European Medicines Agency Electrospray ionization Enterotoxigenic Escherichia coli Food and Drug Administration Forced expiratory volume within 1 s The Federal Food, Drug, and Cosmetic Act Fine particle mass Gamma-aminobutyric acid Glucose excursion Gastrointestinal Gastrointestinal tract Geometric mean ratio Geometric standard deviation Hepatic encephalopathy Health and Human Services Hydrophilic interaction liquid chromatography Hypothalamic pituitary adrenal axis High performance liquid chromatography Hydroxypropyl methylcellulose Hydrogenated soy phosphatidylcholine Highly variable Highly variable drugs Individual bioequivalence Orally inhaled corticosteroids Investigational new drug applications International normalized ratio Immediate release Internal standard Incurred sample reanalyses

3 Abbreviations 461 ITT IVIVC IVRT LABAs LBA LC LD50 LIMS LLE LLOQ LMWH mcsrs MD MDD MDP ME MEC MELD MHE MIP MITT MMAD MmCSRS MMF MPA MR MRM MRT MS MTC MVL NCEs NDAs NIR NME NO NSAID NTI OGD OIP OTA paucs PBC PBE PBPK Intent-to-treat In vitro in vivo correlation In vitro drug release testing Long-acting β2 adrenoceptor agonists Ligand binding assays Liquid chromatography Median lethal dose Laboratory information management systems Liquid liquid extraction Lower limit of quantitation Low molecular weight heparin Modified chi-square ratio statistic Multiple dose Maximum daily dose Muramyl dipeptide Matrix effects Minimum effective concentrations Model for end stage liver disease Minimal hepatic encephalopathy Molecularly imprinted polymer Modified intent-to-treat Mass median aerodynamic diameter The median of modified chi-square ratio Mycophenolate mofetil Mycophenolic acid Modified release Multiple reaction monitoring Mean residence time Mass spectrometry Minimum toxic concentrations Multivesicular liposomes New chemical entities New drug applications Near infrared New molecular entity Nitric oxide Non-steroidal anti-inflammatory drug Narrow therapeutic index Office of Generic Drugs Orally inhaled products Office of Technology Assessment Partial area under the curve Population bioequivalence criteria Population bioequivalence Body physiologically based pharmacokinetic

4 462 Abbreviations PC20 PD PD20 PDR PEG P-gp PK PP PP PSD PSE PT QbD QC R RES RLD RMSE RSABE SABAs SAC SD SD SEDDS SIF SIL SONIC SPE SRM T TD TE TEWL TK TLUS T max TNSS UCB UHPLC ULOQ US-FDA UV VCA WHO WSV Provocative concentration that produces a 20 % decrease in FEV1 Pharmacodynamic Provocative dose that produces a 20 % decrease in FEV1 Population difference ratio Polyethylene glycol P-glycoprotein Pharmacokinetic Per-protocol Protein precipitation Particle size distribution Portal systemic encephalopathy Prothrombin Quality-by-design Quality controls Reference Reticuloendothelial system Reference listed drug Root mean square error Reference-scaled average bioequivalence Short-acting β2 adrenoceptor agonists Single actuation content Single dose Standard deviation Self-emulsifying drug delivery system Simulated intestinal fluid Stable isotope labeled Spectrum of neurocognitive impairments in cirrhosis Solid phase extraction Selected reaction monitoring Test Travelers diarrhea Therapeutically equivalent Transepidermal water loss Toxicokinetic Time to last unformed stool Time to peak concentration Total nasal symptom scores Upper-confidence bound Ultra-high performance liquid chromatography Upper limit of quantitation US Food and Drug Administration Ultraviolet Vasoconstrictor assay World Health Organization Within-subject variability

5 Index A Abbreviated new drug applications (ANDAs), 30, 31, 103, , 113, 128, 148, 151, 197, 295, , 354, 355, 369, 370, 381, 383, 403 Aerodynamic particle size distribution (APSD), 39, , 374, 378, 407 Average bioequivalence (ABE), 7, 8, 12, 13, 15, 56, 59 60, 64, 65, 72, 73, 76 79, 88 89, 142, 143, 145, 147, 148, , 164, , , 312, 407 B Bioanalysis, 279, Bioanalytical method, 378, , 437, 441, 442, 444 Bioavailability (BA), 3, 29, 55, 93, 117, 163, 223, 242, 308, 336, 383, 394 Bioequivalence (BE), 1 22, 29 49, 55, 59 67, 77, 88, 89, , , , , , , , , , , , , , 417 Biomarkers, 205, 243, , 267, 268, 384, 423 Biopharmaceutics classification system (BCS), 2, 8 11, 38, 49, 95, , 107, 113, , 141, 318, 408, 409 Biopharmaceutics drug disposition classification system (BDDCS), 2, 11, 127 Biowaivers, 9 10, 38, 44, , 107, 109, , 201 C Carryover, 71, 80, 85, 90, 222 CAT model, 2, 10 11, Clinical endpoints, 17, 18, 22, 34, 37, 49, 75, 91 92, 218, 231, , 337, 350, 357, 386 Clinical endpoint study, 19, 20, 36 37, 55, 91, 216, 230, , , 296, 298, 301, 302, 307, 313, 318, 320, 326, 339, , 355, 357, 358, 362, 369, Clinical study, 149, 190, 215, , 246, 250, 269 Colesevelam, Comparative clinical effect, 241 Critical-dose drugs, 14, 193, 194, 199 Crossover design, 32, 40 43, 48, 66 74, 77 88, 90, 91, 101, 108, 138, 140, 141, 150, 155, 157, 206, 211 D Drug Price Competition and Patent Term Restoration Act, 4 5, 30, 245, 335 Drug release, 12, 21, 39, 164, 167, 168, , 177, 178, 183, 185, 276, 277, 280, 282, 283, 285, , 298, 307, 312, 313, 319, 321, 322, 351, 405 Dry powder inhalers (DPI), 19, , 376, , 384, 385, 388, 389 E Early exposure, 15, 33, 165, 166, , 177, 181, 183, 184 Enantiomers, L.X. Yu and B.V. Li (eds.), FDA Bioequivalence Standards, AAPS Advances in the Pharmaceutical Sciences Series 13, DOI / , The United States Government

6 464 Index Endogenous compounds, 47 49, 419, 423, 430 Excipient effects, , F Food-drug interaction, 100, 106 Food effects, 10, 95, 96, , 403 G Gastric emptying, 10, 12, 43, 93, 95 97, , 110, 118, 120, 122, 128, 129, 322, 396, 399, 400, 402, 403 Gastrointestinal drugs, 16 17, 20, 333 Gastrointestinal ph, Generic drug products, 6, 8, 13, 31, 112, 138, 140, 141, 149, 190, 204, 208, 215, 218, 237, 242, 243, 246, 247, 295, 298, 299, 338, 355, 360 Guidance, 2, 33, 59, 95, 121, 146, 172, 193, 217, 249, 275, 296, 338, 378, 402, 418 H Highly variable drugs, 2, 11 13, 32, 41, 49, 88, , 172, 204, 307, 379, 407 High metabolism, 11, 127 High permeability, 10, 103, 119, 122, 125, 126, 130, 132 High solubility, 10, 17, 103, 122, 129, 130, 298, 303, 318 I Incurred sample reanalysis (ISR), Individual bioequivalence (IBE), 2, 7 8, 13, 56, 63 66, 74, 84 88, 142, 206, 286 Inhalation products, 18 20, 36, 39 Intestinal transit, 10, 12, 41, 93, 97, , 122, 131, 308, 399, 400 Investigational new drug, 30, 128, 378 In vitro and in vivo correlations (IVIVCs), 289, 393, In vitro binding assay, 300 In vitro dissolution, 10, 17, 38 39, 43, 44, 103, 105, 121, 128, 132, 183, 215, , 302, 303, , , 318, 321, 400, In vitro release testing, 351 L Lanthanum carbonate, 17, 39, 225, , 303, Liposome, 20 22, Local action, 18 20, 217, 242, 243, 315, 317, 370, 387 M Mesalamine, 16, 17, , 178, 296, , 326 Metabolites, 45 46, 48, 127, 181, 215, 216, 219, 253, 267, 297, 301, 302, 308, 309, 312, 408, 417, 418, 423, 425, 430, 434, , 445, Metered dose inhalers, 218, 227, 231, 232, , , 376, , 388, 389 Method validation, 223, 236, 417, 424, , 434, 435, 438 Methylphenidate extended-release products, Microdialysis, 230, 355, 358, 359 Modeling and simulation (M&S), 16, 22, 183, 221, Morphology, 277, 287 Multilamellar, , 282, 283, 289 Multiple dose (MD), 13, 19, 42, 43, 55, 56, 66, 164, 179, 228, 230, 316, 317, 334, 408 Multivesicular, 275, 277 N Narrow therapeutic index (NTI) drugs, 2, 5, 13 15, 32, 41, 49, 88, 128, , 407 Narrow therapeutic range, 14, 64, , 201, 205 Narrow therapeutic ratio, 4, 14, 193, 195 Narrow therapeutic window, 14, 105, 193 Nasal spray, 18, 19, 37, 217, 253, , , 379, 380, New drug application (NDA), 30, 110, 128, 148, 149, 180, 197, 295, 335, 337, 369, 370, 381, 383, 403 O Orlistat, 224, 225, 228, 230, 296, 302, 303, , 326, 383

7 Index 465 P Parallel design, 40, 41, 43, 66, 67, 79, 84, 90, 91, 262, 268, 301 Parent drug, 45 46, 253, 308, 309, 408, 430, 441, 447 Partial AUC (PAUC), 2, 15, 16, 33, 34, 149, , 303, 307, 312, 313, 326, 407, 408 Partial exposure, 15, Peak exposure, 15, 33 Pharmacodynamic endpoint, 35, 36, , 321, 378, 380 Pharmacodynamics, 14, 19, 20, 197, 215, 296, 300, 381, 383 Pharmacodynamic study, 36, 182, 183, 228, 382 Pharmacokinetics (PK), 5, 19, 29, 56, 163, 189, 215, 242, 273, 296, 334, 368, 398, 417 Physicochemical characterization, 274, , 313 Physiologically based absorption models, 406 Population bioequivalence (PBE), 56, 60 62, 73, 79 84, 287 R Racemate, Reference-scaled average bioequivalence approach, 13 15, 88 89, 108, 142, , , 209, 211, 312, 379 Regulation, 2 4, 29, 32, 49, 55, 66, 101, 102, 107, 129, 137, 163, 193, 195, 245, 246, 252, , 325, 336, 338, 347, 362, 417 Regulatory documentation, 438 Replicate study design, 8, 40, 147 Rifaximin, 17, 249, , 262, , 268, 269, 302, 303 S Sample analysis, 426, 430, 432, 433, , 440, 441, 445, Sample size, 12 14, 67, 72 75, , 145, 151, 172, 176, 177, 184, 201, 204, 221, 237, 379, 437, Single-dose (SD), 6, 19, 40 45, 48, 55, 90, 103, 108, 110, 138, 150, 164, 181, 182, , 227, 228, 232, 285, 310, 316, 378, 379, 383, 388, 408 Size, 2, 37, 67, 96, 139, 167, 198, 221, 247, 275, 313, 360, 370, 395, 421 Skin, 36, 118, 206, 220, 242, 280, 333 Skin stripping, 230, Solution, 6, 8, 10, 18, 30, 37, 43, , 129, 131, 163, 180, 243, 256, , 289, 298, 318, 322, 324, 336, 337, , 351, 361, 377, 379, 405, 423, 424, 430, 432, 442, 443, 446 Sprinkle study, Stability, 22, 31, 103, 123, 124, 127, 138, 234, 235, , 343, 347, 384, 421, 424, 425, , 435, , , 449, 450, 452 Study design, 5, 8, 12 15, 29, 36, 37, 40, 56, 66 74, 81, 86, 92, 108, , , 151, 152, 198, , , 227, 228, 232, 235, 237, 243, 248, 258, 357, 359, 371, , , 387, 408, 409 Study power, 72 74, 139, 140, 145, 149 Surface properties, 280, 374 Surrogate endpoint, 219, 243, T Tacrolimus, 45, 193, 194, 197, , 352 Topical products, 230, 304, 336, 337, 354, 356, 357 Total exposure, 15, 33, 164 U Unilamellar, , , 289 V Vancomycin, 16, 17, 259, 296, 302, 303, , 326 W Warfarin, 193, 194, 197, , 208 Z Zolpidem extended-release products, 15, 179,