Methods: Revision of the EMA website of publicly available initial marketing-authorisation documents. Analysis of the changes made in approval documents since their initial release upon CMA authorization, covering the period 2006 to 2020. Data on the type of drug, clinical areas, pivotal trial, and changes made on type of authorisation through the years was extracted for analysis. Cut-off date for data extraction was 28 of February 2022.
[New release] o mercado de aes em 25 episdios
Objectives: To evaluate the safety and efficacy of intravenous infusion of DF in the prevention and treatment of acute respiratory distress and cytokine release syndrome in patients with SARS-CoV-2 infection.
Objectives: To analyse the effect of SJW on tacrolimus pharmacokinetics using immediate-release (Prograf; IR-Tac) and prolonged-release (Envarsus; PR-Tac) formulations and to explore whether individual factors (CYP3A4 activity estimated with a midazolam microdose, CYP3A5 genetic polymorphism) correlate with the pharmacokinetic changes.
Introduction: Esomeprazole has short plasma half-life which can cause insufficient gastric acid suppression during the nighttime in some patients. To overcome the shortcoming of the esomeprazole, a novel dual delayed-release formulation of esomeprazole (HIP1601) was developed.
Conclusions: The use of the "benefit-risk" concept to determine the dosage regimen of anti-tuberculosis drugs allowed us to unify the approach for choosing the dosing interval, as well as to develop rules for dividing fixed tablet forms if it is impossible to use them in the full dose of the release form.
Objectives: Eicosanoids (prostaglandins and leukotrienes) are released once the organism is infected by the virus. The aim of this study is to evaluate the role of eicosanoids and their therapeutic targeting in COVID-19.
Background: Pharmacogenetic polymorphisms in drug metabolizing enzymes as cytochrome P450 monooxygenases affect individual drug exposure. Depending on the location of respective polymorphisms within the protein, either folding, substrate binding or catalytic capacity can be altered. CYP2C8 activity is determined by a genetic polymorphism leading to decreased metabolism of drugs and endogenous CYP2C8 substrates as arachidonic acid. Alterations within the catalytic cycle of CYP450 enzymes can lead to decomposition of reactive intermediates and release of dioxide- and peroxide-anions, which in turn cause oxidative stress.
Conclusion: The release profile of Risperidone ISM allows for rapid achievement of plasma levels similar to those observed at steady-state after oral risperidone treatment. Therefore, direct switch after 24 hours from the last oral EU risperidone dose (after 7 days usage) to Risperidone ISM treatment can be done in stable patients with schizophrenia with no time lag, maintaining steady-state levels of the active moiety throughout treatment and without oral supplementation or loading doses.
O prazo para os vencedores da rodada pagarem à União o valor do bônus de assinatura termina em 28 de setembro, conforme cronograma da ANP. O valor do bônus é calculado com base na expectativa do mercado quanto ao potencial produtivo dos blocos disputados e ao grau de competição pela área na rodada de licitação. A assinatura dos contratos de partilha de produção está prevista para ocorrer até o dia 30 de novembro. 2ff7e9595c
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