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José Homero De Souza Filho*
Autor invitado por SIIC

Influência da alimentação no perfil farmacocinético da venlafaxina

Cronicas de autores AVALIAÇÃO DA INFLUÊNCIA DA ALIMENTAÇÃO NA FARMACOCINETICA DA VENLAFAXINA

Conclui-se que os medicamentos atendem os critérios para serem considerados bioequivalente de acordo com as normas da ANVISA e FDA. Obtive-se aumento nos parâmetros farmacocinéticos (Cmáx e ASC) e redução dos eventos adversos quando os medicamentos foram administrados 30 minutos após a alimentação.
*José Homero De Souza Filho
describe para SIIC los aspectos relevantes de su trabajo
RELATIVE BIOAVAILABILITY OF TWO FORMULATIONS OF VENLAFAXINE EXTENDED-RELEASE 75-MG CAPSULES IN HEALTHY BRAZILIAN MALE VOLUNTEERS: A SINGLE-DOSE, RANDOMIZED-SEQUENCE, OPEN-LABEL, TWO-PERIOD CROSSOVER STUDY IN THE FASTING AND FED STATES

Clinical Therapeutics,
32(12):2088-2096

Esta revista, clasificada por SIIC Data Bases, integra el acervo bibliográfico
de la Biblioteca Biomédica (BB) SIIC.
Institución principal de la investigación
*Núcleo de Desenvolvimento Farmacêutico e Cosméticos da Universidade Federal de Pernambuco - Nudfac/ufpe, Recife, Brasil
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Referencias bibliográficas
1. Troy S, Dilea C, Leister P, et al. Pharmacokinetics of oncedaily venlafaxine extended release in healthy volunteers. Curr Ther Res 58:504-514, 1997.
2. Holliday SM, Benfield P. Venlafaxine. A review of its pharmacology and therapeutic potential in depression. Drugs 49:280-294, 1995.
3. Gonzalez Ruelas E, Diaz Martinez A, Martinez Ruiz R, for the Venlafaxine-Global Awareness Program Study Collaborative Group. An open assessment of the acceptability, efficacy and tolerance of venlafaxine in usual care settings. Curr Ther Res Clin Exp 58:609-630, 1997.
4. Preskorn S. Pharmacotherapeutic profile of venlafaxine. Eur Psychiatry 12(Suppl 4):285s-294s, 1997.
5. Gutierrez MA, Stimmel GL, Aiso JY. Venlafaxine: A 2003 update. Clin Ther 25:2138-2154, 2003.
6. Stahl SM, Entsuah R, Rudolph RL. Comparative efficacy between venlafaxine and SSRIs: A pooled analysis of patients with depression. Biol Psychiatry 52:1166-1174, 2002.
7. Deakin B, Dursun S. Optimizing antidepressant treatment: Efficacy and tolerability. Int Clin Psychopharmacol 17(Suppl 1):S13-S24, 2002.
8. Sisenwine SF, Politowski J, Birk K, et al. A prefactory investigation of the metabolic disposition of WY-45,030 in man. Acta Pharmacol Toxicol 59:312, 1986.
9. Howell SR, Husbands GE, Scatina JA, Sisenwine SF. Metabolic disposition of 14C-venlafaxine in mouse, rat, dog, rhesus monkey and man. Xenobiotica 23:349-359, 1993.
10. Klamerus KJ, Maloney K, Rudolph RL, et al. Introduction of a composite parameter to the pharmacokinetics of venlafaxine and its active O-desmethyl metabolite. J Clin Pharmacol 32:716-724, 1992.
11. Troy SM, Parker VD, Fruncillo RJ, Chiang ST. The pharmacokinetics of venlafaxine when given in a twice-daily regimen. J Clin Pharmacol 35:404-409, 1995.
12. Hicks DR, Wolaniuk D, Russell A, et al. A high-performance liquid chromatographic method for the simultaneous determination of venlafaxine and O-desmethylvenlafaxine in biological fluids. Ther Drug Monit 16:100-107, 1994.
13. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 1170. Evidence Guide for Relative Bioavailability/ Bioequivalence of Medicines [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2006.
14. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Food-effect bioavailability and fed bioequivalence studies: Study design, data analysis, and labeling. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf. Accessed October 3, 2008.
15. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 899. Guidelines for validation of analytical and bioanalytical methods [in Portuguese]. Brasília, Brasil:Diário Oficial da União; 2003.
16. Hirsch AF, ed. Good Laboratory Practice Regulations. New York, NY: Marcel Dekker; 1989.
17. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products-general considerations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf. Accessed October 3, 2008.
18. Ritschel WA, Kearns GL. Handbook of basic pharmacokinetics-Including clinical applications. 6th ed. Washington, DC:American Pharmacists Association, 2004.
19. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 898. Guidelines for planning and performing the statistical phase of relative bioavailability and bioequivalence studies [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2003.
20. Hsuan FC. Estimating treatment means in a mixed-effect ANOVA model for bioequivalence studies. Biometrics 49:703-713, 1993.
21. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15:657-680, 1987.
22. Chow SC, Liu JP. Design and analysis of bioavailability and bioequivalence studies. 2nd ed. New York, NY: Marcel Dekker, 2000.
23. Anderson S, Hauck WW. A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Comm Stat Theor Meth 12:2663-2692, 1983.
24. World Health Organization (WHO). Working document QAS/04.093/ Rev.4. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. Draft revision. http://www.who.int/medicines/ services/expertcommittees/pharmprep/QAS04_093Rev4_final.
1. Troy S, Dilea C, Leister P, et al. Pharmacokinetics of oncedaily venlafaxine extended release in healthy volunteers. Curr Ther Res 58:504-514, 1997.
2. Holliday SM, Benfield P. Venlafaxine. A review of its pharmacology and therapeutic potential in depression. Drugs 49:280-294, 1995.
3. Gonzalez Ruelas E, Diaz Martinez A, Martinez Ruiz R, for the Venlafaxine-Global Awareness Program Study Collaborative Group. An open assessment of the acceptability, efficacy and tolerance of venlafaxine in usual care settings. Curr Ther Res Clin Exp 58:609-630, 1997.
4. Preskorn S. Pharmacotherapeutic profile of venlafaxine. Eur Psychiatry 12(Suppl 4):285s-294s, 1997.
5. Gutierrez MA, Stimmel GL, Aiso JY. Venlafaxine: A 2003 update. Clin Ther 25:2138-2154, 2003.
6. Stahl SM, Entsuah R, Rudolph RL. Comparative efficacy between venlafaxine and SSRIs: A pooled analysis of patients with depression. Biol Psychiatry 52:1166-1174, 2002.
7. Deakin B, Dursun S. Optimizing antidepressant treatment: Efficacy and tolerability. Int Clin Psychopharmacol 17(Suppl 1):S13-S24, 2002.
8. Sisenwine SF, Politowski J, Birk K, et al. A prefactory investigation of the metabolic disposition of WY-45,030 in man. Acta Pharmacol Toxicol 59:312, 1986.
9. Howell SR, Husbands GE, Scatina JA, Sisenwine SF. Metabolic disposition of 14C-venlafaxine in mouse, rat, dog, rhesus monkey and man. Xenobiotica 23:349-359, 1993.
10. Klamerus KJ, Maloney K, Rudolph RL, et al. Introduction of a composite parameter to the pharmacokinetics of venlafaxine and its active O-desmethyl metabolite. J Clin Pharmacol 32:716-724, 1992.
11. Troy SM, Parker VD, Fruncillo RJ, Chiang ST. The pharmacokinetics of venlafaxine when given in a twice-daily regimen. J Clin Pharmacol 35:404-409, 1995.
12. Hicks DR, Wolaniuk D, Russell A, et al. A high-performance liquid chromatographic method for the simultaneous determination of venlafaxine and O-desmethylvenlafaxine in biological fluids. Ther Drug Monit 16:100-107, 1994.
13. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 1170. Evidence Guide for Relative Bioavailability/ Bioequivalence of Medicines [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2006.
14. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Food-effect bioavailability and fed bioequivalence studies: Study design, data analysis, and labeling. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf. Accessed October 3, 2008.
15. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 899. Guidelines for validation of analytical and bioanalytical methods [in Portuguese]. Brasília, Brasil:Diário Oficial da União; 2003.
16. Hirsch AF, ed. Good Laboratory Practice Regulations. New York, NY: Marcel Dekker; 1989.
17. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products-general considerations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf. Accessed October 3, 2008.
18. Ritschel WA, Kearns GL. Handbook of basic pharmacokinetics-Including clinical applications. 6th ed. Washington, DC:American Pharmacists Association, 2004.
19. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 898. Guidelines for planning and performing the statistical phase of relative bioavailability and bioequivalence studies [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2003.
20. Hsuan FC. Estimating treatment means in a mixed-effect ANOVA model for bioequivalence studies. Biometrics 49:703-713, 1993.
21. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15:657-680, 1987.
22. Chow SC, Liu JP. Design and analysis of bioavailability and bioequivalence studies. 2nd ed. New York, NY: Marcel Dekker, 2000.
23. Anderson S, Hauck WW. A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Comm Stat Theor Meth 12:2663-2692, 1983.
24. World Health Organization (WHO). Working document QAS/04.093/ Rev.4. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. Draft revision. http://www.who.int/medicines/ services/expertcommittees/pharmprep/QAS04_093Rev4_final.
1. Troy S, Dilea C, Leister P, et al. Pharmacokinetics of oncedaily venlafaxine extended release in healthy volunteers. Curr Ther Res 58:504-514, 1997.
2. Holliday SM, Benfield P. Venlafaxine. A review of its pharmacology and therapeutic potential in depression. Drugs 49:280-294, 1995.
3. Gonzalez Ruelas E, Diaz Martinez A, Martinez Ruiz R, for the Venlafaxine-Global Awareness Program Study Collaborative Group. An open assessment of the acceptability, efficacy and tolerance of venlafaxine in usual care settings. Curr Ther Res Clin Exp 58:609-630, 1997.
4. Preskorn S. Pharmacotherapeutic profile of venlafaxine. Eur Psychiatry 12(Suppl 4):285s-294s, 1997.
5. Gutierrez MA, Stimmel GL, Aiso JY. Venlafaxine: A 2003 update. Clin Ther 25:2138-2154, 2003.
6. Stahl SM, Entsuah R, Rudolph RL. Comparative efficacy between venlafaxine and SSRIs: A pooled analysis of patients with depression. Biol Psychiatry 52:1166-1174, 2002.
7. Deakin B, Dursun S. Optimizing antidepressant treatment: Efficacy and tolerability. Int Clin Psychopharmacol 17(Suppl 1):S13-S24, 2002.
8. Sisenwine SF, Politowski J, Birk K, et al. A prefactory investigation of the metabolic disposition of WY-45,030 in man. Acta Pharmacol Toxicol 59:312, 1986.
9. Howell SR, Husbands GE, Scatina JA, Sisenwine SF. Metabolic disposition of 14C-venlafaxine in mouse, rat, dog, rhesus monkey and man. Xenobiotica 23:349-359, 1993.
10. Klamerus KJ, Maloney K, Rudolph RL, et al. Introduction of a composite parameter to the pharmacokinetics of venlafaxine and its active O-desmethyl metabolite. J Clin Pharmacol 32:716-724, 1992.
11. Troy SM, Parker VD, Fruncillo RJ, Chiang ST. The pharmacokinetics of venlafaxine when given in a twice-daily regimen. J Clin Pharmacol 35:404-409, 1995.
12. Hicks DR, Wolaniuk D, Russell A, et al. A high-performance liquid chromatographic method for the simultaneous determination of venlafaxine and O-desmethylvenlafaxine in biological fluids. Ther Drug Monit 16:100-107, 1994.
13. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 1170. Evidence Guide for Relative Bioavailability/ Bioequivalence of Medicines [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2006.
14. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Food-effect bioavailability and fed bioequivalence studies: Study design, data analysis, and labeling. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf. Accessed October 3, 2008.
15. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 899. Guidelines for validation of analytical and bioanalytical methods [in Portuguese]. Brasília, Brasil:Diário Oficial da União; 2003.
16. Hirsch AF, ed. Good Laboratory Practice Regulations. New York, NY: Marcel Dekker; 1989.
17. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products-general considerations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf. Accessed October 3, 2008.
18. Ritschel WA, Kearns GL. Handbook of basic pharmacokinetics-Including clinical applications. 6th ed. Washington, DC:American Pharmacists Association, 2004.
19. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 898. Guidelines for planning and performing the statistical phase of relative bioavailability and bioequivalence studies [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2003.
20. Hsuan FC. Estimating treatment means in a mixed-effect ANOVA model for bioequivalence studies. Biometrics 49:703-713, 1993.
21. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15:657-680, 1987.
22. Chow SC, Liu JP. Design and analysis of bioavailability and bioequivalence studies. 2nd ed. New York, NY: Marcel Dekker, 2000.
23. Anderson S, Hauck WW. A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Comm Stat Theor Meth 12:2663-2692, 1983.
24. World Health Organization (WHO). Working document QAS/04.093/ Rev.4. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. Draft revision. http://www.who.int/medicines/ services/expertcommittees/pharmprep/QAS04_093Rev4_final.
1. Troy S, Dilea C, Leister P, et al. Pharmacokinetics of oncedaily venlafaxine extended release in healthy volunteers. Curr Ther Res 58:504-514, 1997.
2. Holliday SM, Benfield P. Venlafaxine. A review of its pharmacology and therapeutic potential in depression. Drugs 49:280-294, 1995.
3. Gonzalez Ruelas E, Diaz Martinez A, Martinez Ruiz R, for the Venlafaxine-Global Awareness Program Study Collaborative Group. An open assessment of the acceptability, efficacy and tolerance of venlafaxine in usual care settings. Curr Ther Res Clin Exp 58:609-630, 1997.
4. Preskorn S. Pharmacotherapeutic profile of venlafaxine. Eur Psychiatry 12(Suppl 4):285s-294s, 1997.
5. Gutierrez MA, Stimmel GL, Aiso JY. Venlafaxine: A 2003 update. Clin Ther 25:2138-2154, 2003.
6. Stahl SM, Entsuah R, Rudolph RL. Comparative efficacy between venlafaxine and SSRIs: A pooled analysis of patients with depression. Biol Psychiatry 52:1166-1174, 2002.
7. Deakin B, Dursun S. Optimizing antidepressant treatment: Efficacy and tolerability. Int Clin Psychopharmacol 17(Suppl 1):S13-S24, 2002.
8. Sisenwine SF, Politowski J, Birk K, et al. A prefactory investigation of the metabolic disposition of WY-45,030 in man. Acta Pharmacol Toxicol 59:312, 1986.
9. Howell SR, Husbands GE, Scatina JA, Sisenwine SF. Metabolic disposition of 14C-venlafaxine in mouse, rat, dog, rhesus monkey and man. Xenobiotica 23:349-359, 1993.
10. Klamerus KJ, Maloney K, Rudolph RL, et al. Introduction of a composite parameter to the pharmacokinetics of venlafaxine and its active O-desmethyl metabolite. J Clin Pharmacol 32:716-724, 1992.
11. Troy SM, Parker VD, Fruncillo RJ, Chiang ST. The pharmacokinetics of venlafaxine when given in a twice-daily regimen. J Clin Pharmacol 35:404-409, 1995.
12. Hicks DR, Wolaniuk D, Russell A, et al. A high-performance liquid chromatographic method for the simultaneous determination of venlafaxine and O-desmethylvenlafaxine in biological fluids. Ther Drug Monit 16:100-107, 1994.
13. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 1170. Evidence Guide for Relative Bioavailability/ Bioequivalence of Medicines [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2006.
14. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Food-effect bioavailability and fed bioequivalence studies: Study design, data analysis, and labeling. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf. Accessed October 3, 2008.
15. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 899. Guidelines for validation of analytical and bioanalytical methods [in Portuguese]. Brasília, Brasil:Diário Oficial da União; 2003.
16. Hirsch AF, ed. Good Laboratory Practice Regulations. New York, NY: Marcel Dekker; 1989.
17. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products-general considerations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf. Accessed October 3, 2008.
18. Ritschel WA, Kearns GL. Handbook of basic pharmacokinetics-Including clinical applications. 6th ed. Washington, DC:American Pharmacists Association, 2004.
19. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 898. Guidelines for planning and performing the statistical phase of relative bioavailability and bioequivalence studies [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2003.
20. Hsuan FC. Estimating treatment means in a mixed-effect ANOVA model for bioequivalence studies. Biometrics 49:703-713, 1993.
21. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15:657-680, 1987.
22. Chow SC, Liu JP. Design and analysis of bioavailability and bioequivalence studies. 2nd ed. New York, NY: Marcel Dekker, 2000.
23. Anderson S, Hauck WW. A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Comm Stat Theor Meth 12:2663-2692, 1983.
24. World Health Organization (WHO). Working document QAS/04.093/ Rev.4. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. Draft revision. http://www.who.int/medicines/ services/expertcommittees/pharmprep/QAS04_093Rev4_final.
Autor invitado
24 de febrero, 2011
Descripción aprobada
0 de , 0000
Reedición siicsalud
5 de octubre, 2017

Acerca del trabajo completo
AVALIAÇÃO DA INFLUÊNCIA DA ALIMENTAÇÃO NA FARMACOCINETICA DA VENLAFAXINA
Título original en castellano
ESTUDO DE BIOEQUIVALÊNCIA DE DUAS FORMULAÇÕES DE CAPSULA DE LIBERAÇÃO CONTROLADA DE VENLAFAXINA DE 75 MG EM VOLUNTARIOS BRASILEIROS SADIOS DO SEXO MASCULINO: DOSE UNICA, ALEATORIO, ABERTO, CRUZADO SOB CONDIÇÃO DE JEJUM E ALIMENTADO.
Autores
José Homero De Souza Filho1, Felipe Nunes Bonifácio2, Danilo César Galindo Bedor,3, Virna Ligiane Ramos4, Carlos Eduardo Miranda De Sousa,5, Luiz F Lens Sardón6, Leila Bastos Leal7, Roberto Carlos Debom Moreira8, Davi Pereira De Santana9
1 Farmacêutico, Núcleo de Desenvolvimento Farmacêutico e Cosméticos da Universidade Federal de Pernambuco - Nudfac/ufpe, Recife, Brasil, Pesquisador Principal
2, Núcleo de Desenvolvimento Farmacêutico e Cosméticos, Departamento de Ciências Farmacêuticas,universidade Federal de Pernambuco
3, Núcleo de Desenvolvimento Farmacêutico e Cosméticos, Departamento de Ciências Farmacêuticas,universidade Federal de Pernambuco
4, Núcleo de Desenvolvimento Farmacêutico e Cosméticos, Departamento de Ciências Farmacêuticas,universidade Federal de Pernambuco
5, Núcleo de Desenvolvimento Farmacêutico e Cosméticos, Departamento de Ciências Farmacêuticas,universidade Federal de Pernambuco
6, Núcleo de Desenvolvimento Farmacêutico e Cosméticos, Departamento de Ciências Farmacêuticas,universidade Federal de Pernambuco
7, Núcleo de Desenvolvimento Farmacêutico e Cosméticos, Departamento de Ciências Farmacêuticas,universidade Federal de Pernambuco
8, Cristália Produtos Químicos Farmacêuticos Ltda
9, Núcleo de Desenvolvimento Farmacêutico e Cosméticos, Departamento de Ciências Farmacêuticas,universidade Federal de Pernambuco
Acceso a la fuente original
Clinical Therapeutics
http://www.elsevier.com/wps/find/journaldescription.cws_home/525050/description#description
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