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The research objectives of Drug Delivery and Disposition are focused on enhancing drug bioavailability of dosage forms for extravascular administration using pharmaceutical-technological approaches (new drug formulations and process technology) as well as biopharmaceutical strategies (based on knowledge of mechanisms underlying drug absorption and hepatobiliary disposition). Significant contributions have been made in the understanding of the physicochemical principles behind formulation strategies for poorly soluble drugs like amorphous solid dispersions, nanoparticles, and mesoporous drug loaded silica. The Laboratory innovates in the development of preclinical models for ADMETox profiling; these model systems include in situ intestinal perfusion in mice (enabling the use of KO and humanized mice in intestinal absorption studies) and hepatocyte-based prediction of drug-induced cholestasis.

Pieter Annaert Patrick Augustijns Thomas Bouillon Guy Van den Mooter

Intestinal drug disposition – Biopharmaceutics

Drug Delivery and Disposition has a strong track record in the biorelevant profiling of intestinal drug absorption, covering all underlying processes including dissolution, precipitation, degradation and permeation. For this purpose, a wide range of simulation models is available, including the in vitro Caco-2 cell culture system, the Ussing chamber system and the in situ intestinal perfusion system. In addition, Drug Delivery and Disposition is able and licensed to perform whole animal absorption and pharmacokinetic experiments. Physiology-based pharmacokinetic modelling (Simcyp® Simulator) is available to extrapolate experimental data to human pharmacokinetics. One of the major targets involves the biorelevant and predictive evaluation of absorption-enabling strategies, including solubilization and supersaturation of poorly soluble drugs. In this respect, Drug Delivery and Disposition has elaborated a ground-breaking approach for evaluating intraluminal drug and formulation behavior in humans, involving the aspiration and characterization of gastrointestinal fluids. All absorption studies are supported by well-developed analytical equipment (LC-UV, -fluo, -MS/MS) to assess concentrations of drugs, excipients and endogenous compounds in biological matrices.

Hepatic drug disposition and drug-induced liver injury

In the field of hepatobiliary drug disposition and drug-drug interaction assessment, drug delivery and disposition has implemented the full spectrum of non-clinical model systems of the liver including: rat/human liver microsomes, rat/human hepatocytes in suspension, sandwich-cultured hepatocytes, cell lines transfected with hepatic drug transporters, isolated perfused rat liver and in vivo. Isolation and cryopreservation of plateablerodent hepatocytes and preparation of liver subcellular fractions is performed in-house. The research group has characterized several fluorescent transporter probes for evaluation and live imaging (by confocal microscopy) of drug transport processes in hepatocytes. Drug clearance prediction in special populations (e.g. pediatric), transporter-based pharmacokinetic boosting and liver unbound concentration assessment form major research objectives. The group has also developed and validated a holistic, hepatocyte-based in vitro model for identification of drug candidates showing risk for drug-induced cholestasis . The model has been mechanistically validated by bile acid profiling in sandwich-cultured hepatocytes. Computational expertise includes in vitro-in vivo extrapolation (IVIVE) algorithms for clearance prediction (SimCYP, R), compartmental and non-compartmental pharmacokinetic data analysis, as well as population pharmacokinetic analysis (NONMEM) of clinical exposure data. The group has taken the lead in generation of large in vitro transporter inhibition data sets leading to in silico models for structure-based prediction of transporter inhibition . Bioanalytical activities include LC-UV/FLUO/MSMS for preclinical and clinical samples.

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I always look forward to raising this topic with either my online or in-class graduate students. Regardless of the course I am instructing, tolerance and leadership has relevance. After all, we want our current graduate students to be able to run effective operations and make important decisions. To make this a reality these future leaders must enable their teams to be willing and active participants. Decisions with poor results should be expected to occur depending on the circumstances.

So why is the use of tolerance an important and effective way to manage? I will ask our readers to recall if they ever participated or were the recipient of criticism from their direct manager as a result of a mistake that was made. I would venture to say not all of you recall this as a pleasurable experience. I personally recall sitting in a managerial review with an upper manager that was displeased with how a project was proceeding. Poor decisions were made by the engineering team forcing the project to run behind schedule. The yelling and screaming that came from this manager embarrassed everyone in attendance. The team members were not only embarrassed but became fearful of facing the same fate someday in the future. This manager, by her actions, single handedly changed the team dynamic from one of collaboration to defensive posturing.

Conservative decision making took root and any type of risk was avoided at all costs. This manager’s intolerance to mistakes yielded a sub optimal project. Displaying tolerance for failure in decision making is an effective way for a leader to drive extraordinary long term results. One must realize that failure, due to poor decision making, is only temporary. If used correctly, tolerance for poor decision making will allow learning for future success. Intolerance, on the other hand, will drive behavior that is offensive in nature and will harm future decision making.

However, using tolerance when poor decisions are made provides an effective leader with a spring board for learning and growth of the team he/she manages. Concluding this setback is temporary in nature, driving for the root cause of the poor decision and deploying corrective actions to get back on track are the actions an effective leader pursues with their team. Using tolerance and avoiding personal unconstructive criticism is the correct path to follow. Using the poor decision as an opportunity for future growth of the team is where the leader should focus energy.

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