Preclinical pharmacokinetic/pharmacodynamic modeling and simulation in the pharmaceutical industry: an IQ consortium survey examining the current landscape.

The application of modeling and simulation techniques is increasingly common in preclinical stages of the drug discovery and development process. A survey focusing on preclinical pharmacokinetic/pharmacodynamics (PK/PD) analysis was conducted across pharmaceutical companies that are members of the International Consortium for Quality and Innovation in Pharmaceutical Development. Based on survey responses, ~68% of companies use preclinical PK/PD analysis in all therapeutic areas indicating its broad application. An important goal of preclinical PK/PD analysis in all pharmaceutical companies is for the selection/optimization of doses and/or dose regimens, including prediction of human efficacious doses. Oncology was the therapeutic area with the most PK/PD analysis support and where it showed the most impact. Consistent use of more complex systems pharmacology models and hybrid physiologically based pharmacokinetic models with PK/PD components was less common compared to traditional PK/PD models. Preclinical PK/PD analysis is increasingly being included in regulatory submissions with ~73% of companies including these data to some degree. Most companies (~86%) have seen impact of preclinical PK/PD analyses in drug development. Finally, ~59% of pharmaceutical companies have plans to expand their PK/PD modeling groups over the next 2 years indicating continued growth. The growth of preclinical PK/PD modeling groups in pharmaceutical industry is necessary to establish required resources and skills to further expand use of preclinical PK/PD modeling in a meaningful and impactful manner.

Compartmental analysis of ranitidine doubled peak plasma profile after oral administration to healthy volunteers

The aim of this study was to describe the double peak plasma pharmacokinetic profile of ranitine after oral administration to healthy volunteers using non-compartmental and compartmental analysis. A single 300mg dose of ranitide was given to ten healthy volunteers (5 male and 5 female). Blood samples were drawn at different times and analyzed by HPLC. Plasma profiles were evaluated by non-compartmental and compartmental approaches. The non-compartmental parameters determined were k (0.0054 ñ 0.0010 min-1), t 1/2 (2.2 ñ 0.4 h), Vd steady state/F (265.3 ñ 70.6L), Cl/F (84.8 ñ 24.3 L/h) and AUC (225916 ñ 54099 ng*min/mL)...

Avaliação da atividade antimicrobiana de Cymbopogon citratus / Evaluation of the antimicrobial activity of Cymbopogon citratus

Cymbopogon citratus (DC) Stapf. é uma gramínea, conhecida popularmente como capim-cidró, capim-cheiroso, erva-cidreira, entre outros, e, em inglês, "lemon grass". A população utiliza o chá ou abafado, preparado a partir de suas folhas, como calmante, digestivo, estomáquico, em dores de cabeça, antiespasmódico, entre outras aplicações. Devido às propriedades antimicrobianas apresentadas pelo óleo volátil de capim-cidró, este trabalho tem por objetivo avaliar a atividade antibacteriana e antifúngica do óleo volátil, extratos aquosos e hidroetanólico, obtidos a partir das folhas frescas e secas da planta. A atividade antimicrobiana foi avaliada pelo método de difusão em ágar, frente aos microrganismos...