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1.
J Pharm Sci ; 113(6): 1653-1663, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38382809

RESUMO

Drug-Combination Nanoparticles (DcNP) are a novel drug delivery system designed for synchronized delivery of multiple drugs in a single, long-acting, and targeted dose. Unlike depot formulations, slowly releasing drug at the injection site into the blood, DcNP allows multiple-drug-in-combination to collectively distribute from the injection site into the lymphatic system. Two distinct classes of long-acting injectables products are proposed based on pharmacokinetic mechanisms. Class I involves sustained release at the injection site. Class II involves a drug-carrier complex composed of lopinavir, ritonavir, and tenofovir uptake and retention in the lymphatic system before systemic access as a part of the PBPK model validation. For clinical development, Class II long-acting drug-combination products, we leverage data from 3 nonhuman primate studies consisting of nine PK datasets: Study 1, varying fixed-dose ratios; Study 2, short multiple dosing with kinetic tails; Study 3, long multiple dosing (chronic). PBPK validation criteria were established to validate each scenario for all drugs. The models passed validation in 8 of 9 cases, specifically to predict Study 1 and 2, including PK tails, with ritonavir and tenofovir, fully passing Study 3 as well. PBPK model for lopinavir in Study 3 did not pass the validation due to an observable time-varying and delayed drug accumulation, which likely was due to ritonavir's CYP3A inhibitory effect building up during multiple dosing that triggered a mechanism-based drug-drug interaction (DDI). Subsequently, the final model enables us to account for this DDI scenario.


Assuntos
Fármacos Anti-HIV , Combinação de Medicamentos , Lopinavir , Modelos Biológicos , Nanopartículas , Ritonavir , Tenofovir , Ritonavir/farmacocinética , Ritonavir/administração & dosagem , Lopinavir/farmacocinética , Lopinavir/administração & dosagem , Tenofovir/farmacocinética , Tenofovir/administração & dosagem , Animais , Fármacos Anti-HIV/farmacocinética , Fármacos Anti-HIV/administração & dosagem , Preparações de Ação Retardada/farmacocinética , Masculino , Sistemas de Liberação de Medicamentos/métodos , Humanos
2.
J Reprod Med ; 61(3-4): 95-100, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27172630

RESUMO

OBJECTIVE: To evaluate the perceived quality of and satisfaction with sex education among University of New Mexico (UNM) college students. STUDY DESIGN: Survey methods utilized with 18-21- year-old UNM freshmen and sophomores who graduated from a New Mexico high school. The survey included questions about type of sex education, satisfaction with sex education (on a 5-point Likert scale), and impact on sexual decision-making and was emailed to participants. RESULTS: A total of 9,866 surveys were emailed; 2,441 were returned (response rate = 24.7%); 415 did not attend high school in New Mexico, leaving 2,024 surveys in the analytic sample. Comprehensive sex education received higher ratings than abstinence-only or no sex education (3.29 ± 0.03 vs. 2.53 ± 0.07 vs. 1.87 ± 0.08, respectively, p<0.0001). More students receiving comprehensive sex education than abstinence-only education reported improved ability to make decisions about sexual initiation (66.6% vs. 54.0%; p = 0.0005), pregnancy prevention (92.7% vs. 72.9%; p < 0.0001), sexually transmitted, infection prevention (92.5% vs. 70.4%; p < 0.0001), and avoidance of unwanted sex (77.6% vs. 65.8%; p = 0.0003). CONCLUSION: New Mexico college students were more satisfied with comprehensive sex education in high school. New Mexico should consider establishing a state requirement for comprehensive sex education.


Assuntos
Comportamento do Consumidor/estatística & dados numéricos , Educação Sexual/métodos , Estudantes , Adolescente , Feminino , Humanos , Masculino , New Mexico , Gravidez , Instituições Acadêmicas , Comportamento Sexual , Infecções Sexualmente Transmissíveis/prevenção & controle , Inquéritos e Questionários , Universidades , Adulto Jovem
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