Search results for "pharmacokinetic"
showing 4 items of 474 documents
In Vitro Evaluation of Poly(lactide-co-glycolide) In Situ Forming Gels for Bedaquiline Fumarate Salt and Pharmacokinetics Following Subcutaneous Inje…
2021
This study evaluated in vitro and in vivo drug release of bedaquiline from in situ forming gels (ISGs) containing 200 mg eq./g bedaquiline fumarate salt prepared with four different grades of poly(d,l-lactide) (PDLLA) or poly(d,l-lactide-co-glycolide) (PLGA) with a lactide/glycolide ratio of 50/50 or 75/25 and acid (A) or ester (E) end-capping in N-methyl-2-pyrrolidone at a polymer/solvent ratio of 20/80% (w/w). Mean in vitro drug release in 0.05 M phosphate buffer pH 7.4 with 1% (w/v) sodium lauryl sulphate was 37.3, 47.1, 53.3, and 62.3% within 28 days for ISGs containing PLGA5050A, PDLLA, PLGA7525A, and PLGA7525E, respectively. The data suggested that drug release was primarily controlle…
DEVELOPMENT & QUALIFICATION OF BIOASSAYS FOR THE DETERMINATION OF THE BIOACTIVITY, PREDICTIVE PHARMACOKINETICS AND POTENTIAL IMMUNOGENICITY OF THERAP…
2021
The critical quality attributes of a given biotherapeutic monoclonal antibody (mAb), its molecular characterization, functional assessment and effector function analysis should be defined and profiled in detail during the life cycle of a biotherapeutic drug. In the past, this product characterization was simple and standardized. In today’s complex world of biologics, success demands a more thoughtful approach and drug developers are investing in advanced analytics much earlier in the development process. Indeed, investing in selected sophisticated and state of the art analytics in early developmental phases of a therapeutic monoclonal antibody may mitigate risks by confirming that the drug …
Aportación de la monitorización farmacocinética de vancomicina a la calidad farmacoterapéutica y seguridad del paciente neonato prematuro
2014
Vancomicina es un antibiótico utilizado con gran frecuencia en pacientes neonatos prematuros ingresados en las Unidades de Cuidados Intensivos Neonatales. La elevada variabilidad en los parámetros farmacocinéticos en este grupo de población representa la mayor barrera en el desarrollo y en la optimización de regímenes de dosificación. Esta situación favorece el desarrollo de diversas recomendaciones basadas en modelos farmacocinéticos poblacionales y nomogramas de dosificación, que consideran, para el cálculo de la dosis, variables como la edad postconcepcional, postnatal, creatinina sérica o el peso de los pacientes. Sin embargo, la experiencia clínica ha puesto de relieve que las concentr…
Voltammetric determination of platinum in perfusate and blood: Preliminary data on pharmacokinetic study of arterial infusion with oxaliplatin
2012
Abstract Because Platinum Group Elements have found widespread use in catalytic converters in cars and as chemotherapeutic agent, interest in the development of reliable analytical methods is carried out in order to monitor these analita in humans to protect the citizen's health. Considering that information on the levels of many trace elements in biological matrices is scarce and for many non-essential elements, baseline levels in the population, and especially in those particularly exposed to the risk are lacking, in this paper we optimize an analytical method for biological matrices, using a voltammetric technique to measure the concentration of Pt in blood and perfusate. The amount of P…