INDEX Note: Italicized page locators indicate figures/photos; tables are noted with t. AASLD. See American Association for molecular characteristics and ACE genotype, heart failure and, 486 the Study of Liver Diseases therapeutic use, 582t ACE genotype D, 486 AAV. See Adeno-associated virus other applications and additional ACE inhibitors. See Angiotensin- Abatacept (Orencia) information, 166 converting enzyme (ACE) clinical pharmacology, 164 pharmacokinetics, 165 inhibitors dosage form, 163 recommended dosage and Acel-Imune (diphtheria and tetanus dosage form, pharmacokinetics, and monitoring requirements, 165 toxoids and acellular pertussis disposition data, 556t role in therapy, 166 vaccine adsorbed) drug interactions, 164 route of administration, 165 dosage form, pharmacokinetics, and general description, 163 target, product type, indications, disposition data, 576t indications and use, 163 FDA approval year, 148t molecular characteristics and molecular characteristics and therapeutic response, 166 therapeutic use, 612t therapeutic use, 582t ABC transporters, protein, feature, and ACIP. See Advisory Committee for other applications, 165 total number of genes, 527t Immunization Practices pharmacokinetics, 164 Abelcet, 452 Acoustic filters, perfusion recommended dosing and Abilify, off-label promotion of, configurations and, 70 monitoring requirements, 163 settlement involving, 119t Acquired disorders, gene and cell role in therapy, 164 Abrin, construction of immunotoxins therapy and, 497, 497t route of administration, 163 and, 455, 455t ACR. See American College of target, product type, indications, Absorption, distribution, metabolism, Rheumatology FDA approval year, 148t and elimination Acromegaly therapeutic response, 164 new drugs and, 521 refractory, Somavert in treatment of, Abbott, revenue, market share, new molecular entities and, 14 348, 349 productivity, and research preclinical studies and, 108 Sandostatin in treatment for, 346 investments of, 5t Absorption, of recombinant protein Somatuline Depot in treatment of, Abbreviated new drug applications, pharmaceuticals, 85–86, 100 33, 340 111, 116–117 Absorption rate SST analogs and treatment of, 312 Abbreviations prescription drugs and, 80 Acrylated Fv products, recombinant, for common amino acids, COPYRIGHTEDsymbol, mathematical relationship, MATERIAL 458 623t–625t and physiological variables, 83 ACT. See Adoptive cell therapy explanation for, 626t–631t ACA. See Affordable Care Act Actemra (tocilizumab), 156 Abciximab (ReoPro), 147, 227 Academy of Managed Care Pharmacy, dosage form, 206 clinical pharmacology, 165 541 dosage form, pharmacokinetics, and dosage form, 165 Accelerated approval, 114 disposition data, 562t dosage form, pharmacokinetics, and Accelerated development and review indications and use, 206 disposition data, 556t process, use of, 107, 108 molecular characteristics and drug interactions, 165 Accupril (quinapril), restenosis after therapeutic use, 590t general description, 165 stent implantation and, 486 recommended dosage and indications and use, 165 ACE D allele, 486 monitoring requirements, 206 Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition. Rodney J. Y. Ho. © 2013 John Wiley & Sons, Inc. Published 2013 by John Wiley & Sons, Inc. 633 Chapter No.: 3 Title Name: RodneyJHo Comp. by: TSanthosh Date: 20 Aug 2013 Time: 01:44:57 AM Stage: Printer Page Number: 633 0002007355.INDD 633 8/20/2013 1:44:57 AM 634 INDEX Actemra (tocilizumab) (cont’d) molecular characteristics and for severe combined role in therapy, 206 therapeutic use, 591t immunodeficiency, 361 route of administration, 206 ADA gene, 361 ADH. See Antidiuretic hormone target, product type, indications, Adagen (PEG-ADA), 447 ADH1 gene, ADH isoenzymes FDA approval year, 149t Adagen (pegademase bovine) encoded by, 481 ACTH. See Adrenocorticotropic dosage form, 381 ADH2 gene, ADH isoenzymes hormone indications and use, 381 encoded by, 481 ActHIB (Haemophilus b conjugate role in therapy, 382 ADH3 gene, ADH isoenzymes vaccine, tetanus toxoid route of administration, 381 encoded by, 481 conjugate) Adalimumab (Humira) Adipocytes, 90, 213 dosage form, pharmacokinetics, and clinical pharmacology, 167 Adjuvants, vaccine, 398, 400, 405 disposition data, 577t dosage form, 167 Adjuvant systems, novel, and vaccine molecular characteristics and dosage form, pharmacokinetics, and delivery technologies, 400t therapeutic use, 613t disposition data, 556t ADME. See Absorption, distribution, Actimmune (interferon gamma 1b) drug interactions, 167 metabolism, and elimination dosage form, 300 general description, 166 Adoption of new therapies and dosage form, pharmacokinetics, and indications and use, 166 medicines, 536 disposition data, 574t molecular characteristics and Adoptive cell therapy, metastatic indications and use, 300 therapeutic use, 582t melanoma and, 505–506 molecular characteristics and other applications and additional Adrenocorticotropic hormone, sources therapeutic use, 608t information, 168 and clinical use of, 309t off-label promotion of, settlement pharmacokinetics, 167 Advanced Cell Technology, 510 involving, 118, 119t recommended dosage and Advate (antihemophilic factor recommended dosage and monitoring requirements, 167 (recombinant), plasma/albumin monitoring requirements, 300 role in therapy, 168 free) role in therapy, 301 route of administration, 167 dosage form, pharmacokinetics, and route of administration, 300 sponsors, indications, annual sales in disposition data, 565t Activase (alteplase), 33 millions, 6t molecular characteristics and clinical pharmacology, 374 target, product type, indications, therapeutic use, 594t dosage form, 373 FDA approval year, 148t Advate (antihemophilic factor VIII) dosage form, pharmacokinetics, and therapeutic response, 168 dosage form, 232 disposition data, 563t Adaptive immunity, 393 general description, 231–232 indications and use, 373 ADA-SCID, 506 indications and use, 232 molecular characteristics and ADCC. See Antibody-dependent pharmacokinetics, 233 therapeutic use, 592t cellular cytotoxicity recommended dosage and recommended dosage and monitoring Adcetris (brentuximab vedotin) monitoring requirements, requirements, 373–374 dosage form, 177 232–233 role in therapy, 374 dosage form, pharmacokinetics, and route of administration, 232 route of administration, 373 disposition data, 557t Adverse drug reactions, 96, 474 Activated V (Va) calcium, 225 drug interactions, 177 Advexin, 506 Activin A, 511, 511t indications and use, 176–177 Advisory Committee for Immunization Acute coronary syndrome molecular characteristics and Practices aptamer-based therapies and, 497 therapeutic use, 583t on bivalent HPV vaccine, 411 Integrilin in treatment of, 241 recommended dosage and on hepatitis B vaccine, 410 Acute lymphoblastic leukemia, monitoring requirements, 177 on quadrivalent HPV vaccine, 411 Leukine in treatment of, 249 role in therapy, 177 on varicella vaccine, 415 Acute myelogenous leukemia, Leukine route of administration, 177 on Zostavax, 416 in treatment of, 249 target, product type, indications, Affordable Care Act, biosimilars and, Acute myeloid leukemia, aptamer- FDA approval year, 149t 133, 134 based therapies and, 497 ADCs. see Antibody-drug conjugates Aflibercept (Eylea) Acute myocardial infarction Adefovir dipivoxil (Hepsera), 273 clinical pharmacology, 168–169 Activase in treatment of, 373, 374 Adeno-associated virus, 500 disposition, 169 Retavase in treatment of, 385, 386 as gene therapy for hemophilia, 503, dosage form, 168 TNKase in treatment of, 386, 387 504 dosage form, pharmacokinetics, and Acyclovir, 9, 9, 97 Adenosine deaminase (Adagen), 449, 506 disposition data, 556t Acylated insulin derivatives, 462 clearance and, 447 general description, 168 ADA. See Adenosine deaminase dosage form, pharmacokinetics, and indications and use, 168 Adagen (adenosine deaminase) disposition data, 562t molecular characteristics and dosage form, pharmacokinetics, and molecular characteristics and therapeutic use, 582t disposition data, 562t therapeutic use, 591t pharmacokinetics, 169 Chapter No.: 3 Title Name: RodneyJHo Comp. by: TSanthosh Date: 20 Aug 2013 Time: 01:44:57 AM Stage: Printer Page Number: 634 0002007355.INDD 634 8/20/2013 1:44:57 AM INDEX 635 recommended dosage and dosage form, 288 target, product type, indications, monitoring requirements, 168 dosage form, pharmacokinetics, and FDA approval year, 148t role in therapy, 169 disposition data, 573t therapeutic response, 171 route of administration, 168 drug interactions, 289 Alendronate (Fosamax), 315 therapeutic response, 169 general description, 288 Alferon-N (interferon alfa-n3, human Africa, sub-Saharan, social indications and use, 288 leukocyte derived) entrepreneurs and conjugated molecular characteristics and dosage form, pharmacokinetics, and meningococcal vaccine for, 21 therapeutic use, 607t disposition data, 573t African American men, SRD5A2 and other applications and additional molecular characteristics and risk of prostate cancer in, 484 information, 289 therapeutic use, 608t African Americans, primaquine- pharmacokinetics, 289 Alglucerase (Ceradase) mediated hemolysis symptom recommended dosage and dosage form, pharmacokinetics, and and, 473 monitoring requirements, 289 disposition data, 562t Agalsidase, for Fabry’s disease, 363 role in therapy, 289 molecular characteristics and Agalsidase beta (Fabrazyme), 363 route of administration, 289 therapeutic use, 591t clinical pharmacology, 371 therapeutic response, 289 Alglucosidase,