-
1
-
-
78650589857
-
-
American Society of Health System Pharmacists, Bethesda, Md, G.K. McEvoy (Ed.)
-
Risperidone. AHFS Drug Information 2009 2009, 2499-2505. American Society of Health System Pharmacists, Bethesda, Md. G.K. McEvoy (Ed.).
-
(2009)
Risperidone. AHFS Drug Information 2009
, pp. 2499-2505
-
-
-
2
-
-
70350104487
-
-
US Dept of Health and Human Services, US Food and Drug Administration, Accessed May 5, 2007
-
Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations US Dept of Health and Human Services, US Food and Drug Administration, Accessed May 5, 2007. http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=020272&TABLE1=OB_Rx.
-
Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations
-
-
-
3
-
-
0027475985
-
A Canadian multicenter placebo-controlled study of fixed dose of risperidone and haloperidol in the treatment of chronic schizophrenic patients [published correction appears in J Clin Psychopharmacol. 1993;13:149]
-
Chouinard G, Jones B, Remington G, et al. A Canadian multicenter placebo-controlled study of fixed dose of risperidone and haloperidol in the treatment of chronic schizophrenic patients [published correction appears in J Clin Psychopharmacol. 1993;13:149]. J Clin Psychopharmacol 1993, 13:25-40.
-
(1993)
J Clin Psychopharmacol
, vol.13
, pp. 25-40
-
-
Chouinard, G.1
Jones, B.2
Remington, G.3
-
4
-
-
0028342655
-
Risperidone in the treatment of schizophrenia
-
Marder SR, Meibach RC Risperidone in the treatment of schizophrenia. Am J Psychiatry. 1994, 151:825-835.
-
(1994)
Am J Psychiatry.
, vol.151
, pp. 825-835
-
-
Marder, S.R.1
Meibach, R.C.2
-
5
-
-
0030737934
-
Effects of clozapine, thioridazine, risperidone and haloperidol on behavioral tests related to extrapyramidal motor function
-
Trevitt JT, Lyons M, Aberman J, et al. Effects of clozapine, thioridazine, risperidone and haloperidol on behavioral tests related to extrapyramidal motor function. Psychopharmacology (Berl). 1997, 132:74-81.
-
(1997)
Psychopharmacology (Berl).
, vol.132
, pp. 74-81
-
-
Trevitt, J.T.1
Lyons, M.2
Aberman, J.3
-
7
-
-
0027433081
-
Absorption, metabolism, and excretion of risperidone in humans
-
Mannens G, Huang ML, Meuldermans W, et al. Absorption, metabolism, and excretion of risperidone in humans. Drug Metab Dispos. 1993, 21:1134-1141.
-
(1993)
Drug Metab Dispos.
, vol.21
, pp. 1134-1141
-
-
Mannens, G.1
Huang, M.L.2
Meuldermans, W.3
-
8
-
-
33846590147
-
Treatment of schizophrenia with paliperidone extended-release tablets: A 6-week placebo-controlled trial
-
Kane J, Canas F, Kramer M, et al. Treatment of schizophrenia with paliperidone extended-release tablets: A 6-week placebo-controlled trial. Schizophr Res. 2007, 90:147-161.
-
(2007)
Schizophr Res.
, vol.90
, pp. 147-161
-
-
Kane, J.1
Canas, F.2
Kramer, M.3
-
9
-
-
0027436269
-
Pharmacokinetics of the novel antipsychotic agent risperidone and the prolactin response in healthy subjects
-
Huang ML, Van Peer A, Woestenborghs R, et al. Pharmacokinetics of the novel antipsychotic agent risperidone and the prolactin response in healthy subjects. Clin Pharmacol Ther. 1993, 54:257-268.
-
(1993)
Clin Pharmacol Ther.
, vol.54
, pp. 257-268
-
-
Huang, M.L.1
Van Peer, A.2
Woestenborghs, R.3
-
10
-
-
0028096538
-
Risperidone. A review of its pharmacology and therapeutic potential in the treatment of schizophrenia
-
Grant S, Fitton A Risperidone. A review of its pharmacology and therapeutic potential in the treatment of schizophrenia. Drugs. 1994, 48:253-273.
-
(1994)
Drugs.
, vol.48
, pp. 253-273
-
-
Grant, S.1
Fitton, A.2
-
11
-
-
0023756442
-
Biochemical profile of risperidone, a new antipsychotic
-
Leysen JE, Gommeren W, Eens A, et al. Biochemical profile of risperidone, a new antipsychotic. J Pharmacol Exp Ther. 1988, 247:661-670.
-
(1988)
J Pharmacol Exp Ther.
, vol.247
, pp. 661-670
-
-
Leysen, J.E.1
Gommeren, W.2
Eens, A.3
-
12
-
-
0028333931
-
Regional brain distribution of risperidone and its active metabolite 9-hydroxy-risperidone in the rat
-
van Beijsterveldt LE, Geerts RJ, Leysen JE, et al. Regional brain distribution of risperidone and its active metabolite 9-hydroxy-risperidone in the rat. Psychopharmacology (Berl). 1994, 114:53-62.
-
(1994)
Psychopharmacology (Berl).
, vol.114
, pp. 53-62
-
-
van Beijsterveldt, L.E.1
Geerts, R.J.2
Leysen, J.E.3
-
13
-
-
0028625436
-
In vivo pharmacological profile of 9-hydroxyrisperidone, the major metabolite of the novel antipsychotic risperidone
-
Megens AA, Awouters FH In vivo pharmacological profile of 9-hydroxyrisperidone, the major metabolite of the novel antipsychotic risperidone. Drug Dev Res. 1994, 33:399-412.
-
(1994)
Drug Dev Res.
, vol.33
, pp. 399-412
-
-
Megens, A.A.1
Awouters, F.H.2
-
14
-
-
0031717385
-
Distribution after repeated oral ad- ministration of different dose levels of risperidone and 9-hydroxy- risperidone in the brain and other tissues of rat
-
Aravagiri M, Yuwiler A, Marder SR Distribution after repeated oral ad- ministration of different dose levels of risperidone and 9-hydroxy- risperidone in the brain and other tissues of rat. Psychopharmacology (Berl). 1998, 139:356-363.
-
(1998)
Psychopharmacology (Berl).
, vol.139
, pp. 356-363
-
-
Aravagiri, M.1
Yuwiler, A.2
Marder, S.R.3
-
15
-
-
55349097509
-
Bioequivalence study of a generic risperidone (Iperdal) in healthy Thai male volunteers
-
Mahatthanatrakul W, Nontaput T, Sriwiriyajan S, Ridtitid W Bioequivalence study of a generic risperidone (Iperdal) in healthy Thai male volunteers. Songklanakarin J Sci Technol. 2008, 30:307-312.
-
(2008)
Songklanakarin J Sci Technol.
, vol.30
, pp. 307-312
-
-
Mahatthanatrakul, W.1
Nontaput, T.2
Sriwiriyajan, S.3
Ridtitid, W.4
-
16
-
-
13844251076
-
Influence of age and gender on risperidone plasma concentrations
-
Aichhorn W, Weiss U, Marksteiner J, et al. Influence of age and gender on risperidone plasma concentrations. J Psychopharmacol. 2005, 19:395-401.
-
(2005)
J Psychopharmacol.
, vol.19
, pp. 395-401
-
-
Aichhorn, W.1
Weiss, U.2
Marksteiner, J.3
-
17
-
-
33746781255
-
Second-generation antipsychotics: Is there evidence for sex differences in pharmacokinetic and adverse effect profiles?
-
Aichhorn W, Whitworth AB, Weiss EM, Marksteiner J Second-generation antipsychotics: Is there evidence for sex differences in pharmacokinetic and adverse effect profiles?. Drug Saf. 2006, 29:587-598.
-
(2006)
Drug Saf.
, vol.29
, pp. 587-598
-
-
Aichhorn, W.1
Whitworth, A.B.2
Weiss, E.M.3
Marksteiner, J.4
-
18
-
-
84855623134
-
-
Association of Southeast Asian Na- tions (ASEAN), Consultative Com- mittee for Standards and Quality-Pharmaceutical Product Working groupConsultative Com- mittee for Standards and Quality-Pharmaceutical Product Working group, Accessed January 20, 2007
-
ASEAN guidelines for the conduct of bioavailability and bioequivalence studies 2004, Association of Southeast Asian Na- tions (ASEAN), Consultative Com- mittee for Standards and Quality-Pharmaceutical Product Working groupConsultative Com- mittee for Standards and Quality-Pharmaceutical Product Working group, Accessed January 20, 2007. http://www.fda.moph.go.th.
-
(2004)
ASEAN guidelines for the conduct of bioavailability and bioequivalence studies
-
-
-
19
-
-
34347392440
-
-
Drug Control Division, Food and Drug Administration, Ministry of Public Health, Accessed January 20, 2007
-
Thailand Guidelines for the conduct of bioavailability and bioequivalence studies 2005, Drug Control Division, Food and Drug Administration, Ministry of Public Health, Accessed January 20, 2007. http://www.fda.moph.go.th.
-
(2005)
Thailand Guidelines for the conduct of bioavailability and bioequivalence studies
-
-
-
20
-
-
65549101892
-
-
World Medical Association Decla-ration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects, Accessed June 20, 2006
-
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the 52nd WMA General Assem- bly, Edinburgh, Scotland October 2000, World Medical Association Decla-ration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects, Accessed June 20, 2006. http://www.wma.net/en/30publications/10policies/b3/index.html.
-
(2000)
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the 52nd WMA General Assem- bly, Edinburgh, Scotland
-
-
-
21
-
-
84855640255
-
-
European Agency for the Evaluation of Medicinal Products, International Conference on Harmonisation-World Health OrganizationInternational Conference on Harmonisation-World Health Organization, Accessed June 20, 2006
-
Guideline for Good Clinical Practice. ICH Topic E 6 European Agency for the Evaluation of Medicinal Products, International Conference on Harmonisation-World Health OrganizationInternational Conference on Harmonisation-World Health Organization, Accessed June 20, 2006. http://www.eortc.be/Services/Doc/ICH_GCP.pdf.
-
Guideline for Good Clinical Practice. ICH Topic E 6
-
-
-
22
-
-
0003455042
-
-
US Dept of Health and Human Services, Food and Drug AdministrationFood and Drug Administration, Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research, Accessed January 14, 2006
-
Guidance for Industry: Bioavailability and bioequivalence studies for orally administered drug products-general considerations 2002, US Dept of Health and Human Services, Food and Drug AdministrationFood and Drug Administration, Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research, Accessed January 14, 2006. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf.
-
(2002)
Guidance for Industry: Bioavailability and bioequivalence studies for orally administered drug products-general considerations
-
-
-
23
-
-
0005905707
-
-
US Dept of Health and Human Services, Food and Drug AdministrationFood and Drug Administration, Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research, Center for Veterinary MedicineCenter for Veterinary Medicine, Guidance for IndustryGuidance for Industry, Accessed January 14, 2006
-
Bioanalytical method validation 2001, US Dept of Health and Human Services, Food and Drug AdministrationFood and Drug Administration, Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research, Center for Veterinary MedicineCenter for Veterinary Medicine, Guidance for IndustryGuidance for Industry, Accessed January 14, 2006. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070107.pdf.
-
(2001)
Bioanalytical method validation
-
-
-
24
-
-
0038383461
-
Pharmacokinetic comparison of fast-disintegrating and conventional tablet formulations of risperidone in healthy volunteers
-
van Schaick EA, Lechat P, Remmerie BM, et al. Pharmacokinetic comparison of fast-disintegrating and conventional tablet formulations of risperidone in healthy volunteers. Clin Ther. 2003, 25:1687-1699.
-
(2003)
Clin Ther.
, vol.25
, pp. 1687-1699
-
-
van Schaick, E.A.1
Lechat, P.2
Remmerie, B.M.3
-
26
-
-
4243400462
-
Statistical consideration for bioavailability/bioequivalence studies
-
Marcel Dekker, New York, NY, P.G. Welling, L.S. Tse Francis (Eds.)
-
Yuh L Statistical consideration for bioavailability/bioequivalence studies. Pharmacokinetics: Regulatory, Industrial, Academic Perspectives 1995, 479-502. Marcel Dekker, New York, NY. 2nd ed. P.G. Welling, L.S. Tse Francis (Eds.).
-
(1995)
Pharmacokinetics: Regulatory, Industrial, Academic Perspectives
, pp. 479-502
-
-
Yuh, L.1
-
27
-
-
0003922013
-
-
US Dept of Health and Human Services, Food and Drug AdministrationFood and Drug Administration, Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research, Accessed January 15, 2006
-
Guidance for Industry. Statistical approaches to establishing bioequivalence 2001, US Dept of Health and Human Services, Food and Drug AdministrationFood and Drug Administration, Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research, Accessed January 15, 2006. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf.
-
(2001)
Guidance for Industry. Statistical approaches to establishing bioequivalence
-
-
-
28
-
-
0026711141
-
Sample size determination for the two one-sided tests procedure in bioequivalence
-
Liu JP, Chow SC Sample size determination for the two one-sided tests procedure in bioequivalence. J Pharmacokinet Biopharm. 1992, 20:101-104.
-
(1992)
J Pharmacokinet Biopharm.
, vol.20
, pp. 101-104
-
-
Liu, J.P.1
Chow, S.C.2
-
29
-
-
0034758459
-
On sample size calculation in bioequivalence trials [published correction appears in J Pharmacokinet Pharmacodyn. 2002; 29:101]
-
Chow SC, Wang H On sample size calculation in bioequivalence trials [published correction appears in J Pharmacokinet Pharmacodyn. 2002; 29:101]. J Pharmcokinet Pharmacodyn 2001, 28:155-169.
-
(2001)
J Pharmcokinet Pharmacodyn
, vol.28
, pp. 155-169
-
-
Chow, S.C.1
Wang, H.2
-
30
-
-
34247894006
-
Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standard, quality controls and study samples
-
Nowatzke W, Woolf E Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standard, quality controls and study samples. AAPS J. 2007, 9:E117-E122.
-
(2007)
AAPS J.
, vol.9
-
-
Nowatzke, W.1
Woolf, E.2
-
31
-
-
34247463792
-
Rapidly disintegrating risperidone in subjects with schizophrenia or schizoaffective disorder: A summary of ten phase I clinical trials assessing taste, tablet disintegrating time, bioequivalence, and tolerability
-
Thyssen A, Remmerie B, D'Hoore P, et al. Rapidly disintegrating risperidone in subjects with schizophrenia or schizoaffective disorder: A summary of ten phase I clinical trials assessing taste, tablet disintegrating time, bioequivalence, and tolerability. Clin Ther. 2007, 29:290-304.
-
(2007)
Clin Ther.
, vol.29
, pp. 290-304
-
-
Thyssen, A.1
Remmerie, B.2
D'Hoore, P.3
-
32
-
-
34147170558
-
Turbulent flow and ternary column-switching on-line clean-up system for high-throughput quantification of risperidone and its main metabolite by LC-MS/MS application to a bioequivalence study
-
Kousoulos C, Dotsikas Y, Loukas YL Turbulent flow and ternary column-switching on-line clean-up system for high-throughput quantification of risperidone and its main metabolite by LC-MS/MS application to a bioequivalence study. Talanta. 2007, 72:360-367.
-
(2007)
Talanta.
, vol.72
, pp. 360-367
-
-
Kousoulos, C.1
Dotsikas, Y.2
Loukas, Y.L.3
-
33
-
-
62749159078
-
Bioequivalence evaluation of two strengths of risperidone tablet formulations in healthy volunteers
-
Cánovas M, Delgadillo J, Torres F, et al. Bioequivalence evaluation of two strengths of risperidone tablet formulations in healthy volunteers. Int J Clin Pharmacol Ther. 2009, 47:124-131.
-
(2009)
Int J Clin Pharmacol Ther.
, vol.47
, pp. 124-131
-
-
Cánovas, M.1
Delgadillo, J.2
Torres, F.3
-
34
-
-
0027141414
-
Bio-International 92, conference on bioavailability, bioequivalence, and pharmacokinetic studies
-
Blume HH, Midha KK Bio-International 92, conference on bioavailability, bioequivalence, and pharmacokinetic studies. J Pharm Sci. 1993, 82:1186-1189.
-
(1993)
J Pharm Sci.
, vol.82
, pp. 1186-1189
-
-
Blume, H.H.1
Midha, K.K.2
-
35
-
-
0028050644
-
Pharmacokinetics of risperidone in chronic schizophrenic patients
-
Borison RL, Diamond B, Pathiraja A, Meibach RC Pharmacokinetics of risperidone in chronic schizophrenic patients. Psychopharmacol Bull. 1994, 30:193-197.
-
(1994)
Psychopharmacol Bull.
, vol.30
, pp. 193-197
-
-
Borison, R.L.1
Diamond, B.2
Pathiraja, A.3
Meibach, R.C.4
|