References
- Chiricozzi A , CaposienaD, GarofaloVet al. A new therapeutic for the treatment of moderate to severe plaque psoriasis: apremilast. Expert Rev. Clin. Immunol. 12 (3), 237–249 (2015).
- Kurd SK , GelfandJM. The prevalence of previously diagnosed and undiagnosed psoriasis in US adults: results from NHANES 2003–2004. J. Am. Acad. Dermatol. 60 (2), 218–224 (2009).
- Kumar N1 , GoldminzAM, KimN, GottliebAB. Phosphodiesterase 4-targeted treatments for autoimmune diseases. BMC Med. 11, 96 (2013).
- Schafer P . Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem. Pharmacol. 83 (12), 1583–1590 (2012).
- Poole RM , BallantyneAD. Apremilast: first global approval. Drugs74 (7), 825–837 (2014).
- US prescribing information of OTEZLA® (apremilast), tablets . Celgene Corporation Summit, NJ 07901. December 2015. www.otezla.com/otezla-prescribing-information.pdf.
- Schafer PH , PartonA, GandhiAKet al. Apremilast, a cAMP phosphodiesterase-4 inhibitor, demonstrates anti-inflammatory activity in vitro and in a model of psoriasis. Br. J. Pharmacol. 159 (4), 842–855 (2010).
- McCann FE , PalfreemanAC, AndrewsMet al. Apremilast, a novel PDE4 inhibitor, inhibits spontaneous production of tumour necrosis factor-alpha from human rheumatoid synovial cells and ameliorates experimental arthritis. Arthritis Res. Ther. 12 (3), R107 (2010).
- Hoffmann M , KumarG, SchaferPet al. Disposition, metabolism and mass balance of [(14)C]apremilast following oral administration. Xenobiotica41 (12), 1063–1075 (2011).
- Gottlieb AB , MathesonRT, MenterAet al. Efficacy, tolerability, and pharmacodynamics of apremilast in recalcitrant plaque psoriasis: a Phase II open-label study. J. Drugs Dermatol. 12 (8), 888–897 (2013).
- Schett G , SloanVS, StevensRM, SchaferP. Apremilast: a novel PDE4 inhibitor in the treatment of autoimmune and inflammatory diseases. Ther. Adv. Musculoskelet. Dis. 2 (5), 271–278 (2010).
- Liu Y , ZhouS, WanY, WuA, PalmisanoM. The impact of co-administration of ketoconazole and rifampicin on the pharmacokinetics of apremilast in healthy volunteers. Br. J. Clin. Pharmacol. 78 (5), 1050–1057 (2014).
- Wu A , RohaneP, NgJet al. Safety/tolerability and pharmacokinetics of multiple oral doses of apremilast in healthy male subjects. Clin. Pharmacol. Ther. 91, S26 (2012).
- Chen LG , WangZ, WangS, LiT, PanY, LaiX. Determination of apremilast in rat plasma by UPLC–MS-MS and its application to a pharmacokinetic study. J. Chromatogr. Sci. doi: 10.1093/chromsci/bmw072 (2016) ( Epub ahead of print).
- Hirabayashi H , SugimotoH, MatsumotoS, AmanoN, MoriwakiT. Development of a quantification method for digoxin, a typical P-glycoprotein probe in clinical and non-clinical studies, using high performance liquid chromatography-tandem mass spectrometry: the usefulness of negative ionization mode to avoid competitive adduct-ion formation. J. Chromatography B. 879 (32), 3837–3844 (2011).
- Iqbal M , EzzeldinE, Al-RashoodKA, AsiriYA, RezkNL. Rapid determination of canagliflozin in rat plasma by UHPLC–MS/MS using negative ionization mode to avoid adduct-ions formation. Talanta132, 29–36 (2015).
- Guidance for Industry Bioanalytical Method Validation, U.S. Department of Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), Editor 2001, US: Rockville, MD, USA. www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf.
- EMEA/CHMP/EWP/192217/2009, Guideline on bioanalytical method validation, European Medicines Agency (2012). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.
- Food and Drug Administration Center for Drug Evaluation and Research (CDER) . NDA Application No. 206088. Pharmacological Review Pharmacokinetic/ADME/Toxicokinetics. www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206088Orig1s000PharmR.
- Dziadosz M , KlintscharM, TeskeJ. Drug detection by tandem mass spectrometry on the basis of adduct formation. J. Chromatogr. B. 955–956, 108–109 (2014).
- Mortier KA , ZhangGF, van PeteghemCH, LambertWE. Adduct formation in quantitative bioanalysis: effect of ionization conditions on paclitaxel. J. Am. Soc. Mass. Spectrom. 15 (4), 585–592 (2004).