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References
Agência Nacional de Vigilância Sanitária (ANVISA) (2002). Manual for Good Bioavailability and Bioequivalence Practices. 1(1). |
|
Araújo LU, Albuquerque KT, Kato KC, Silveira GS, Maciel NR, Spósito PA Barcellos NMS Souza J, Bueno M, Storpirtis S (2010). Generic drugs in Brazil: Historical overview and legislation. Rev. Panam. Salud Publica. 28(6):480-492. |
|
Asenjo LC, Komossa K, Rummel-Kluge C, Hunger H, Schmid F, Schwarz S, Leucht S (2010). Clozapine versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst. Rev. 11:CD006633. |
|
Brazil (1999). Bill n° 9.787, 10 February 1999, provides for sanitary surveillance, establishes the concept of generic drug, provides for the use of generic names in pharmaceutical and other measures. Diário Oficial da União. 11(1):1. |
|
Cohen D, Bogers JP, van Dijk D, Bakker B, Schulte PF (2012). Beyond white blood cell monitoring: Screening in the initial phase of clozapine therapy. J. Clin. Psychiatry 3(10):1307-1312. |
|
da Fonseca BM, Moreno IED, Barroso M, Costa S, Queiroz JA, Gallardo E (2013). Determination of seven selected antipsychotic drugs in human plasma using microextraction in packed sorbent and gas chromatography-tandem mass spectrometry. Anal. Bioanal. Chem. 405(12):3953-3963. |
|
do Carmo Borges NC, Astigarraga RB, Sverdloff CE, Galvinas PR, Borges BC, Moreno RA (2012). Comparative bioavailability of two oral formulations of clozapine in steady state administered in schizophrenic volunteers under individualized dose regime. Curr. Clin. Pharmacol. 7(4):241-253. |
|
Drew L (2013). Clozapine and agranulocytosis: Re-assessing the risks. Australas. Psychiatry 21(4):335-337. |
|
Golden G, Honigfeld G (2008). Bioequivalence of clozapine orally disintegrating 100-mg tablets compared with clozapine solid oral 100-mg tablets after multiple doses in patients with schizophrenia. Clin. Drug. Investig. 28(4):231-239. |
|
Herceg M, Muzinić L, Jukić V (2010). Can we prevent blood dyscrasia (leucopenia, thrombocytopenia) and epileptic seizures induced by clozapine. Psychiatr. Danub. 22(1):85-89. |
|
Kane JM, Correll CU (2010). Past and present progress in the pharmacologic treatment of schizophrenia. J. Clin. Psychiatry 71(9):1115-1124. |
|
Lewis SW, Davies L, Jones PB, Barnes TR, Murray RM, Kerwin R, Taylor D, Hayhurst KP, Markwick A, Lloyd H, Dunn G (2006). Randomised controlled trials of conventional antipsychotic versus new atypical drugs, and new atypical drugs versus clozapine, in people with schizophrenia responding poorly to, or intolerant of current drug treatment. Health Technol. Assess. 10(17):1-165. |
|
Lucas C, Martin J (2013). Smoking and drug interactions. Aust. Prescr. 36:102-104. |
|
Meltzer HY (2012). Clozapine: Balancing safety with superior antipsychotic efficacy. Clin. Schizophr. Relat. Psychoses 6(3):134-144. |
|
Mercolini L, Bugamelli F, Kenndler E, Boncompagni G, Franchini L, Raggi MA (2007). Simultaneous determination of the antipsychotic drugs levomepromazine and clozapine and their main metabolites in human plasma by a HPLC-UV method with solid-phase extraction. J. Chrom. B Analyt. Technol. Biomed. Life Sci. 1:846(1-2):273-280. |
|
Pokorny R, Finkel MJ, Robinson WT (1994). Normal volunteers should not be used for bioavailability or bioequivalence studies of clozapine. Pharm. Res. 11(8):1221. |
|
Rosland M, Szeto P, Procyshyn R, Barr AM, Wasan KM (2007). Determination of clozapine and its metabolite, norclozapine, in various biological matrices using high-performance liquid chromatography. Drug Dev. Ind. Pharm. 33(10):1158-66. |
|
Rumel D, Nishioka SDA, Santos AD (2006). Drug interchangeability: Clinical approach and consumer point of view. Rev. Saúde Pública. 40(5):921-927. |
|
Sarkar S, Grover S (2013). Antipsychotics in children and adolescents with schizophrenia: Asystematic review and meta-analysis. Indian J. Pharmacol. 145(5):439-446. |
|
Suzuki T, Uchida H, Watanabe K, Kashima H (2011). Factors associated with response to Clozapine in schizophrenia: A review. Psychopharmacol. Bull. 44(1):32-60. |
|
Tassaneeyakul W, Kittiwattanagul K, Vannaprasaht S, Kampan J, Tawalee A, Puapairoj P, Tiamkao S, Juthagridsada S, Kukongviriyapan V, Tassaneeyakul W (2005). Steady-state bioequivalence study of clozapine tablet in schizophrenic patients. J. Pharm. Pharm. Sci. 8(1):47-53. |
|
Thomas AA, Friedman JH (2010). Current use of clozapine in Parkinson disease and related disorders. Clin. Neuropharmacol. 33(1):14-16. |
|
United States Food and Drug Administration, Center for Drug Evaluation and Research (US-FDA) (2014). Clozapine tablets: In vivo bioequivalence and in vitro dissolution testing. Guidance for Industry. |
|
Warnez S, Alessi-Severini S (2014). Clozapine: A review of clinical practice guidelines and prescribing trends. BMC Psychiatry 14(1):102. |
|
Wohlfarth A, Toepfner N, Hermanns-Clausen M, Auwärter V (2011). Sensitive quantification of clozapine and its main metabolites norclozapine and clozapine-N-oxide in serum and urine using LC-MS/MS after simple liquid-liquid extraction work-up. Anal. Bioanal. Chem. 400(3):737-746. |
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