메뉴 건너뛰기




Volumn 42, Issue 12, 2014, Pages 1991-2001

Drug disposition and drug-drug interaction data in 2013 FDA new drug applications: A systematic review

Author keywords

[No Author keywords available]

Indexed keywords

AFATINIB; ALOGLIPTIN; BAZEDOXIFENE PLUS CONJUGATED ESTROGEN; CANAGLIFLOZIN; CYTOCHROME P450 3A; DABRAFENIB; DIGOXIN; DOLUTEGRAVIR; ESLICARBAZEPINE ACETATE; FLUTEMETAMOL F 18; FLUTICASONE FUROATE PLUS VILANTEROL; FUMARIC ACID DIMETHYL ESTER; GADOTERATE MEGLUMINE; GLUCURONOSYLTRANSFERASE; IBRUTINIB; LULICONAZOLE; MACITENTAN; MIPOMERSEN; OBINUTUZUMAB; OSPEMIFENE; POMALIDOMIDE; RADIUM CHLORIDE RA 223; RIOCIGUAT; SIMEPREVIR; SOFOSBUVIR; TILMANOCEPT TC 99M; TRAMETINIB; TRASTUZUMAB EMTANSINE; UNINDEXED DRUG; VORTIOXETINE; DRUG;

EID: 84910059806     PISSN: 00909556     EISSN: 1521009X     Source Type: Journal    
DOI: 10.1124/dmd.114.060392     Document Type: Review
Times cited : (43)

References (39)
  • 1
    • 77149165406 scopus 로고    scopus 로고
    • Predicting drug disposition via application of a biopharmaceutics drug disposition classification system
    • Benet LZ (2010) Predicting drug disposition via application of a Biopharmaceutics Drug Disposition Classification System. Basic Clin Pharmacol Toxicol 106:162-167.
    • (2010) Basic Clin Pharmacol Toxicol , vol.106 , pp. 162-167
    • Benet, L.Z.1
  • 2
    • 84857627857 scopus 로고    scopus 로고
    • Effect of cyclosporine and rifampin on the pharmacokinetics of macitentan, a tissue-targeting dual endothelin receptor antagonist
    • Bruderer S, Aänismaa P, Homery MC, Häusler S, Landskroner K, Sidharta PN, Treiber A, and Dingemanse J (2012) Effect of cyclosporine and rifampin on the pharmacokinetics of macitentan, a tissue-targeting dual endothelin receptor antagonist. AAPS J 14:68-78.
    • (2012) AAPS J , vol.14 , pp. 68-78
    • Bruderer, S.1    Aänismaa, P.2    Homery, M.C.3    Häusler, S.4    Landskroner, K.5    Sidharta, P.N.6    Treiber, A.7    Dingemanse, J.8
  • 3
    • 84885166351 scopus 로고    scopus 로고
    • Pharmacokinetic drug interactions involving vortioxetine (Lu AA21004), a multimodal antidepressant
    • Chen G, Lee R, Højer AM, Buchbjerg JK, Serenko M, and Zhao Z (2013) Pharmacokinetic drug interactions involving vortioxetine (Lu AA21004), a multimodal antidepressant. Clin Drug Investig 33:727-736.
    • (2013) Clin Drug Investig , vol.33 , pp. 727-736
    • Chen, G.1    Lee, R.2    Højer, A.M.3    Buchbjerg, J.K.4    Serenko, M.5    Zhao, Z.6
  • 5
    • 77955999532 scopus 로고    scopus 로고
    • Cytochrome P450 3A4 mRNA is a more reliable marker than CYP3A4 activity for detecting pregnane X receptor-activated induction of drug-metabolizing enzymes
    • Fahmi OA, Kish M, Boldt S, and Obach RS (2010) Cytochrome P450 3A4 mRNA is a more reliable marker than CYP3A4 activity for detecting pregnane X receptor-activated induction of drug-metabolizing enzymes. Drug Metab Dispos 38:1605-1611.
    • (2010) Drug Metab Dispos , vol.38 , pp. 1605-1611
    • Fahmi, O.A.1    Kish, M.2    Boldt, S.3    Obach, R.S.4
  • 6
    • 84883304674 scopus 로고    scopus 로고
    • Effect of repeated administration of eslicarbazepine acetate on the pharmacokinetics of simvastatin in healthy subjects
    • Falcão A, Pinto R, Nunes T, and Soares-da-Silva P (2013) Effect of repeated administration of eslicarbazepine acetate on the pharmacokinetics of simvastatin in healthy subjects. Epilepsy Res 106:244-249.
    • (2013) Epilepsy Res , vol.106 , pp. 244-249
    • Falcão, A.1    Pinto, R.2    Nunes, T.3    Soares-da-Silva, P.4
  • 7
    • 84910095028 scopus 로고    scopus 로고
    • FDA (2013a) Package insert. ADEMPAS (Riociguat). FDA application NDA 204819
    • FDA (2013a) Package insert. ADEMPAS (Riociguat). FDA application NDA 204819.
  • 8
    • 84910032480 scopus 로고    scopus 로고
    • FDA (2013b) Package insert. ANORO ELLIPTA (Umeclidinium and vilanterol). FDA application NDA 203975
    • FDA (2013b) Package insert. ANORO ELLIPTA (Umeclidinium and vilanterol). FDA application NDA 203975.
  • 9
    • 84910032479 scopus 로고    scopus 로고
    • FDA (2013c) Package insert. APTIOM Eslicarbazepine acetate. FDA application NDA 022416
    • FDA (2013c) Package insert. APTIOM (Eslicarbazepine acetate. FDA application NDA 022416.
  • 10
    • 84910095027 scopus 로고    scopus 로고
    • FDA (2013d) Package insert. BREO ELLIPTA (Fluticasone and vilanterol). FDA application NDA 204275
    • FDA (2013d) Package insert. BREO ELLIPTA (Fluticasone and vilanterol). FDA application NDA 204275.
  • 11
    • 84910056566 scopus 로고    scopus 로고
    • FDA (2013e) Package insert. BRINTELLIX (Vortioxetine). FDA application NDA 204447
    • FDA (2013e) Package insert. BRINTELLIX (Vortioxetine). FDA application NDA 204447.
  • 12
    • 84910056565 scopus 로고    scopus 로고
    • FDA (2013f) Package insert. DOTAREM (Gadoterate meglumine). FDA application NDA 204781
    • FDA (2013f) Package insert. DOTAREM (Gadoterate meglumine). FDA application NDA 204781.
  • 13
    • 84910075652 scopus 로고    scopus 로고
    • FDA (2013g) Package insert. DUAVEE (Conjugated estrogens and bazedoxifene). FDA application NDA 022247
    • FDA (2013g) Package insert. DUAVEE (Conjugated estrogens and bazedoxifene). FDA application NDA 022247.
  • 14
    • 84910095026 scopus 로고    scopus 로고
    • FDA (2013h) Package insert. GAZYVA (Obinutuzumab). FDA application BLA 125486
    • FDA (2013h) Package insert. GAZYVA (Obinutuzumab). FDA application BLA 125486.
  • 15
    • 84910032478 scopus 로고    scopus 로고
    • FDA (2013i) Package insert. GILOTRIF (Afatinib). FDA application NDA 201192
    • FDA (2013i) Package insert. GILOTRIF (Afatinib). FDA application NDA 201192.
  • 16
    • 84910075651 scopus 로고    scopus 로고
    • FDA (2013j) Package insert. IMBRUVICA (Ibrutinib). FDA application NDA 205552
    • FDA (2013j) Package insert. IMBRUVICA (Ibrutinib). FDA application NDA 205552.
  • 17
    • 84910075650 scopus 로고    scopus 로고
    • FDA (2013k) Package insert. INVOKANA (Canagliflozin). FDA application NDA 204042
    • FDA (2013k) Package insert. INVOKANA (Canagliflozin). FDA application NDA 204042.
  • 18
    • 84910095025 scopus 로고    scopus 로고
    • FDA (2013l) Package insert. KADCYLA (Ado-trastuzumab emtansine). FDA application BLA 125427
    • FDA (2013l) Package insert. KADCYLA (Ado-trastuzumab emtansine). FDA application BLA 125427.
  • 19
    • 84910095024 scopus 로고    scopus 로고
    • FDA (2013m) Package insert. KYNAMRO (Mipomersen). FDA application NDA 203568
    • FDA (2013m) Package insert. KYNAMRO (Mipomersen). FDA application NDA 203568.
  • 20
    • 84910032477 scopus 로고    scopus 로고
    • FDA (2013n) Package insert. LUZU (Luliconazole). FDA application NDA 204153
    • FDA (2013n) Package insert. LUZU (Luliconazole). FDA application NDA 204153.
  • 21
    • 84910095023 scopus 로고    scopus 로고
    • FDA (2013o) Package insert. LYMPHOSEEK (Technetium Tc-99M Tilmanocept). FDA application NDA 202207
    • FDA (2013o) Package insert. LYMPHOSEEK (Technetium Tc-99M Tilmanocept). FDA application NDA 202207.
  • 22
    • 84910075649 scopus 로고    scopus 로고
    • FDA (2013p) Package insert. MEKINIST (Trametinib). FDA application NDA 204114
    • FDA (2013p) Package insert. MEKINIST (Trametinib). FDA application NDA 204114.
  • 23
    • 84910032476 scopus 로고    scopus 로고
    • FDA (2013q) Package insert. NESINA (Alogliptin). FDA application NDA 022271
    • FDA (2013q) Package insert. NESINA (Alogliptin). FDA application NDA 022271.
  • 24
    • 84910075648 scopus 로고    scopus 로고
    • FDA (2013r) Package insert. OLYSIO (Simeprevir). FDA application NDA 205123
    • FDA (2013r) Package insert. OLYSIO (Simeprevir). FDA application NDA 205123.
  • 25
    • 84910075647 scopus 로고    scopus 로고
    • FDA (2013s) Package insert. OPSUMIT (Macitentan). FDA application NDA 204410
    • FDA (2013s) Package insert. OPSUMIT (Macitentan). FDA application NDA 204410.
  • 26
    • 84910056564 scopus 로고    scopus 로고
    • FDA (2013t) Package insert. OSPHENA (Ospemifene). FDA application NDA 203505
    • FDA (2013t) Package insert. OSPHENA (Ospemifene). FDA application NDA 203505.
  • 27
    • 84910056563 scopus 로고    scopus 로고
    • FDA (2013u) Package insert. POMALYST (Pomalidomide). FDA application NDA 204026
    • FDA (2013u) Package insert. POMALYST (Pomalidomide). FDA application NDA 204026.
  • 28
    • 84910032475 scopus 로고    scopus 로고
    • FDA (2013v) Package insert. SOVALDI (Sofosbuvir). FDA application NDA 204671
    • FDA (2013v) Package insert. SOVALDI (Sofosbuvir). FDA application NDA 204671.
  • 29
    • 84910056562 scopus 로고    scopus 로고
    • FDA (2013w) Package insert. TAFINLAR (Dabrafenib). FDA application NDA 202806
    • FDA (2013w) Package insert. TAFINLAR (Dabrafenib). FDA application NDA 202806.
  • 30
    • 84910032474 scopus 로고    scopus 로고
    • FDA (2013x) Package insert. TECFIDERA (Dimethyl fumarate). FDA application NDA 204063
    • FDA (2013x) Package insert. TECFIDERA (Dimethyl fumarate). FDA application NDA 204063.
  • 31
    • 84910056561 scopus 로고    scopus 로고
    • FDA (2013y) Package insert. TIVICAY (Dolutegravir). FDA application NDA 204790
    • FDA (2013y) Package insert. TIVICAY (Dolutegravir). FDA application NDA 204790.
  • 32
    • 84910056560 scopus 로고    scopus 로고
    • FDA (2013z) Package insert. VIZAMYL (Flutemetammol F18 injection). FDA application NDA 203137
    • FDA (2013z) Package insert. VIZAMYL (Flutemetammol F18 injection). FDA application NDA 203137.
  • 33
    • 84910056559 scopus 로고    scopus 로고
    • FDA (2013aa) Package insert. XOFIGO (Radium Ra-223 dichloride). FDA application NDA 203971
    • FDA (2013aa) Package insert. XOFIGO (Radium Ra-223 dichloride). FDA application NDA 203971.
  • 36
    • 72849115627 scopus 로고    scopus 로고
    • The international transporter consortium: A collaborative group of scientists from academia, industry, and the FDA
    • Huang SM, Zhang L, and Giacomini KM (2010) The International Transporter Consortium: a collaborative group of scientists from academia, industry, and the FDA. Clin Pharmacol Ther 87:32-36.
    • (2010) Clin Pharmacol Ther , vol.87 , pp. 32-36
    • Huang, S.M.1    Zhang, L.2    Giacomini, K.M.3
  • 38
    • 84879417173 scopus 로고    scopus 로고
    • Transporter studies in drug development: Experience to date and follow-up on decision trees from the international transporter consortium
    • Tweedie D, Polli JW, Berglund EG, Huang SM, Zhang L, Poirier A, Chu X, and Feng B, on behalf of the International Transporter Consortium; International Transporter Consortium (2013) Transporter studies in drug development: experience to date and follow-up on decision trees from the International Transporter Consortium. Clin Pharmacol Ther 94:113-125.
    • (2013) Clin Pharmacol Ther , vol.94 , pp. 113-125
    • Tweedie, D.1    Polli, J.W.2    Berglund, E.G.3    Huang, S.M.4    Zhang, L.5    Poirier, A.6    Chu, X.7    Feng, B.8    Consortium, I.T.9
  • 39
    • 84862634533 scopus 로고    scopus 로고
    • Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions
    • Zhao P, Rowland M, and Huang SM (2012) Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions. Clin Pharmacol Ther 92:17-20.
    • (2012) Clin Pharmacol Ther , vol.92 , pp. 17-20
    • Zhao, P.1    Rowland, M.2    Huang, S.M.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.