Towards quantitation of the effects of renal impairment. This work was funded by simcyp limited a certara company. Our people a global workforce certaras solutions, which span the discovery, preclinical, and clinical stages of drug development, enable datadriven decisions, leading to more precisely designed trials with a reduced risk of failure and improved subject safety. Amin rostami delam gereft ft fereydoon amin rostami bi marefat. His mission is to ensure that the latest scientific advances in the field of biosimulation are incorporated into all of the drug development efforts by. Rostami leads a team of scientists working on extrapolation of in vitro data on drug metabolism to predict in vivo pharmacokinetics and pharmacodynamics in virtual patient populations. Simcyp releases version of its widely used simulator. Considering age variation when coining drugs as high versus. Professor amin rostami, vp research and development, simcyp, said. Zoe barters research works wwf united kingdom, london. The simcyp populationbased adme simulator request pdf.
Original research open access the simcyp population. Aug 20, 20 certara is developing a systems and populationbased approach to help with early preclinical assessment of drug toxicity risk, said dr. Original research open access the simcyp population based. Simulation and prediction of in vivo drug metabolism. Prediction of the exposure of neonates, infants and children to xenobiotics is likely to be more successful using physiologically based pharmacokinetic models than simplistic allometric scaling, particularly in younger children. The centre for applied pharmacokinetic research capkr is a consortium of academic researchers at the university of manchester and nine industrial pharmaceutical companies. Commenting on the new release, professor amin rostami, vice president of research and development at simcyp, said. Amin rostami hodjegan is an employee of the university of manchester and parttime secondee to simcyp limited a certara company.
In addition to its use in clinical and regulatory approval, the simcyp simulator is actively being leveraged for formulations and pharmaceutics development purposes, said amin. Certara signs research agreement with the hamner institutes. Amin rostamihodjegans research works the university of. His mission is to ensure that the latest scientific advances in the field of biosimulation are incorporated into all of the drug development efforts by various pharmaceutical companies. Certara is dedicated to improving human health through a broad spectrum of software products and. Academic unit of clinical pharmacology, floor m, the royal hallamshire hospital, sheffield s10 2jf, and simcyp ltd, the blades enterprise. Amin rostami 6 album demo kian zibandeh ta paie bi. Delineating the role of various factors in renal disposition. Amin rostami delam gereft ft fereydoon amin rostami 6 album demo amin rostami khodahafez. The companys flagship product the simcyp populationbased adme simulator is used by the worlds top pharmaceutical companies and is recognised as the industrys most sophisticated platform for the simulation of. Listen and download baroon by amin rostami for free now on irantune, browse new musicsmp3s and videos on irantune. Kris wragg bsc software engineering simcyp, sheffield.
Many graduates from his team hold positions in the pharmaceutical industry or academia. In addition to its use in clinical and regulatory approval, the simcyp simulator is actively being leveraged for formulations and pharmaceutics development purposes, said amin rostami, pharmd. Liver cirrhosis is characterized by a decrease in functional hepatocytes, lowered circulating levels of plasma proteins and alterations in blood flow due to the development of portacaval shunts. More than 90% of novel new drug approvals by the us food and drug administration fda are supported by certara software or services. Amin rostami joz eshghe to ft peyman amin amin rostami tik tik. Considering age variation when coining drugs as high. Virtual bioequivalence represents an ideal application for simcyp s pbpk modeling and simulation capabilities. Simulation and prediction of in vivo drug metabolism in.
Simcyp s research is funded by a consortium of pharma companies. Professor amin rostami lecture tickets, mon 18112019 at. Frontiers applications of linking pbpk and pd models to. Sep 30, 2012 prediction of the exposure of neonates, infants and children to xenobiotics is likely to be more successful using physiologically based pharmacokinetic models than simplistic allometric scaling, particularly in younger children. Prediction of the clearance of eleven drugs and associated. As a cofounder of simcyp limited a university of sheffield spinoff acquired by certara he is parttime secondee at certara. Architecture, implementation, and quality assurance masoud jamei1, steve marciniak1, duncan edwards1, kris wragg1, kairui feng1, adrian barnett1 and amin rostamihodjegan1,2 abstract developing a userfriendly platform that can handle a vast number of complex physiologically based. Certara corporation promotes professor amin rostami to senior. Certara, the global biosimulation technologyenabled drug development and drug safety consulting company, today announced that it has promoted amin rostami, pharm. This research was supported by the us food and drug administrations fdas medical countermeasures initiative. Certara celebrates 20th anniversary of the simcyp simulator consortium.
The authors gratefully acknowledge professor amin rostamihodjegan from the university of manchester, manchester, uk and drs sibylle neuhoff and masoud jamei from simcyp ltd, sheffield, uk for their scientific input. Certara is dedicated to improving human health through a broad spectrum of software. It determines the main physiological and biological elements of the system patient attributes that are most significant in interindividual variability of clearance. Simcyps simulators allow in silico prediction of drug absorption, distribution, metabolism and excretion adme and potential drugdrug interactions. Structured literature searches were carried out using medline for the parameters cl and v ss of 17 compounds strictly after intravenous doses. Certara scientists to highlight modelinformed drug development, pbpk, mbma and quantitative systems pharmacology progress at page 2019 posted jun 10, 2019. Simcyp is based in sheffield, uk simcyps simulators allow in silico prediction of drug absorption, distribution, metabolism and excretion and potential drugdrug interactions. Jun 03, 20 masoud jamei, steve marciniak, duncan edwards, kris wrag, kairui feng and adrian barnett are employees in simcyp limited a certara company. Gastrointestinal gi drug absorption is a complex process determined by formulation, physicochemical and biopharmaceutical factors, and gi physiology.
Initial simulations of digoxin plasma concentrationtime profiles and cl r were performed using the default healthy volunteers population file provided. Professor rostami has an active program of training phd students involving proteomics, pbpk, clinical pkpd and precision dosing. Rose, gaohua lu, theresa cain, khaled abduljalil, nikunjkumar patel and masoud jamei are employees of simcyp limited a certara company. In silico modeling of gastrointestinal drug absorption. Amin rostami hodjegan and geoff tucker have a longstanding track record in exploring the scientific background of metabolic drugdrug interactions. Their efforts have culminated in the development of the mddi prediction software simcyp. Zoe barters research while affiliated with wwf united kingdom and other places. Certara is contributing to 28 sessions, showcasing modeling by its pharmacometricians, systems pharmacologists, and experts in pharmacoeconomicshealth economics outcomes research.
Certara scientists to present their latest modeling and. Mechanistic pbpk modeling and simulation has become a key technology in modern drug development. Nov 04, 2019 this is such an exciting time to be working in modelinformed drug development, said certara chief scientific officer professor amin rostami. Prediction of drug kinetics in humans from in vitro data, apr 56, amin rostamihodjegan, phd, simcyp limited, sheffield, uk. He is an original thinker, who can envision how to combine disciplines to disrupt the status quo and improve the drug development paradigm, said certara chief executive. Modeling and data analysis in pharmacokinetics and pharmacodynamics using adapt 5, apr 89, david d. Hodjegan holds shares in certara, a company focusing on model. A semimechanistic model to predict the effects of liver. Certara scientists to give 22 presentations at the aaps. Shifting from clinical studies to predict and confirm, day 2 amin rostamihodjegan moderator 9. Masoud jamei, steve marciniak, duncan edwards, kris wrag, kairui feng and adrian barnett are employees in simcyp limited a certara company. Oct 16, 2019 our organization continues to grow and evolve to tackle new frontiers. He joined certara in 2012 as a cofounder of simcyp limited a university of sheffield spinoff which was acquired by certara.
M jamei, s marciniak, k feng, a barnett, g tucker, a rostamihodjegan. In addition to its use in clinical and regulatory approval, the simcyp simulator is actively being leveraged for formulations and pharmaceutics development purposes, said. In addition to its use in clinical and regulatory approval, the simcyp simulator is actively being leveraged for formulations and pharmaceutics development purposes, said amin rostami, pharmd, phd, certaras chief scientific officer. However, there remains a lack of comparative studies between different models. View the profiles of professionals named amin rostami on linkedin. Certara celebrates 20th anniversary of the simcyp simulator. Simcyp limited is a researchbased company which provides modelling and simulation software to the pharmaceutical industry for use during drug development. Amin rostamihodjegans 402 research works with 139 citations and 6418. Amin rostami joz eshghe to ft peyman amin amin rostami mano too ghalbet negah dar. The simcyp software platform 26, 27 has been widely used for pbpk modeling and simulation of pharmaceutical compounds by multiple commercial and academic groups. The simcyp division of certara uk limited was founded as simcyp limited in 2001 by professors geoff tucker and amin rostami hodjegan as a spinout company from the university of sheffield, uk. Prof amin rostamihodjegan pharmd, phd, fcp, faaps, fjssx.
Certara scientists to highlight modelinformed drug. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. A library of drug trial simulation models and examples. Physiologically based pharmacokinetic software packages gisim, simcyp. The hepatic extraction ratio eh is commonly considered an inherent attribute of drug. Oct 16, 2019 in addition to its use in clinical and regulatory approval, the simcyp simulator is actively being leveraged for formulations and pharmaceutics development purposes, said amin rostami, pharmd. This is such an exciting time to be working in modelinformed drug development, said certara chief scientific officer professor amin rostami. Certara revenue, number of employees, annual growth and. Sep 02, 20 simcyp releases version of its widely used simulator. Considering age variation when coining drugs as high versus low hepatic extraction ratios farzaneh salem, khaled abduljalil, yoshiteru kamiyama, and amin rostami hodjegan simcyp limited a certara company, sheffield, united kingdom f. Physiologically based in silico absorption models have emerged as a widely used and promising supplement to traditional in vitro assays and preclinical in vivo studies. Academic unit of clinical pharmacology, floor m, the royal hallamshire hospital, sheffield s10 2jf, and simcyp ltd, the blades enterprise centre, john street, sheffield, s2 4su, uk amin rostami.
Nov 26, 2014 amin rostami hodjegan is an employee of the university of manchester and parttime secondee to simcyp limited a certara company. However, such models require comprehensive information on the ontogeny of anatomical, physiological and biochemical variables. Depending on the interplay between these parameters and the characteristics of an administered drug, varying degrees of impaired systemic clearance and firstpass. The simcyp populationbased adme simulator citation. Certara revenue, number of employees, annual growth and funding. It is also an excellent addition to the many scientific and regulatory accomplishments that the simcyp team has achieved during the past 20 years, said certara chief scientific officer professor amin rostami. Request pdf the simcyp populationbased adme simulator the simcyp. Publicprivate partnerships influencing drug development and regulatory decisionseuropean experiences with various models.
In vitroin vivo extrapolation ivive of renal excretory clearance clr using the physiologically based kidney models can provide mechanistic insight into the interplay of multiple processes occurring in the renal tubule. Towards further verification of physiologicallybased kidney. Amin rostamihodjegan is an employee of the university of manchester and parttime secondee to simcyp limited a certara company. As a cofounder of simcyp limited a university of sheffield spinoff acquired by. Certara is developing a systems and populationbased approach to help with early preclinical assessment of drug toxicity risk, said dr. Development of submodels of organs within physiologicallybased pharmacokinetic pbpk principles and beyond simple perfusion limitations may be challenging because of underdeveloped in vitroin vivo extrapolation approaches or lack of suitable clinical data for model refinement. Simcyps research is funded by a consortium of pharma companies.
Comparing paediatric intravenous phenytoin doses using physiologically based pharmacokinetic pbpk modelling software article in seizure 33. The simcyp populationbased absorption, distribution, metabolism and excretion simulator is a platform and database for bottomup mechanistic modelling and simulation of the processes of oral absorption, tissue distribution, metabolism and excretion of drugs and drug candidates in healthy and disease populations. Zoe barters research works wwf united kingdom, london and. Our mission is to understand what happens to drugs when they enter the body where they go, how they are metabolised and how quickly. Aug 28, 20 commenting on the new release, professor amin rostami, vice president of research and development at simcyp, said. Certara corporation promotes professor amin rostami to. Simcyp provides platforms for modelling and simulation of drug absorption, distribution, metabolism and excretion adme in virtual human populations and virtual laboratory animals. The v ss data after intravenous administration were collected for fewer drugs because the main focus was on the ability of the nfold metric system to predict parameters rather than the actual predictability of the parameters. Our organization continues to grow and evolve to tackle new frontiers.
Our simcyp simulator can already model the population variability in pharmacokinetic and pharmacodynamic responses and cardiotoxicity scenarios. Amin rostami 6 album demo kian zibandeh ta paie bi kasi. Trevor johnson is a paid employee of simcyp limited a certara company. Simcyp was acquired by certara in 2012 with its name changing to certara uk simcyp division in 2018 and has continued experience dynamic growth. Amin rostamihodjegan and geoff tucker have a longstanding track record in exploring the scientific background of metabolic drugdrug interactions. However, advantage of such models in predicting clinical observations in divergent patient groups is now commonly. Amin represents the epitome of scientific leadership. Amin rostami hodjegan is an employee of the university of manchester and parttime secondee to simcyp. The modeling was performed using simcyp software v18 certara ltd, sheffield, uk. All simulations presented herein were performed using the simcyp populationbased pbpk simulator software, version 14, release 1 simcyp, sheffield, uk jamei et al. The simcyp simulator the simcyp populationbased simulator software. Professor amin rostami lecture tickets, mon 18112019 at 11. Prediction success criteria for pharmacokinetic parameters. Professor rostami has an active program of training phd students involving.
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