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Open Positions at FDA

Details: our mission of providing high quality generic drugs to the American public. Many of the outstanding scientists/researchers trained in DQMM h= ave now joined new and generic drug companies, clinical research organizatio= ns (CROs), consulting firms, and other offices within FDA (e.g. Office of

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Simultaneous pk model of 2 drugs

Details: eous drugs? I would like some suggestions about how to define the dataset and model for= a subcutaneous drug and oral drug being administered on different schedule= s. I would use DVID = 1 and 2 for the two plasma pk observations. I figu= re this soft of thing had to be dealt with in the past when trying to model=

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Fwd: Open Positions at FDA

Details: our mission of providing high quality generic drugs to the American public. Many of the outstanding scientists/researchers trained in DQMM h= ave now joined new and generic drug companies, clinical research organizatio= ns (CROs), consulting firms, and other offices within FDA (e.g. Office of

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RE: Simultaneous pk model of 2 drugs

Details: RE: Simultaneous pk model of 2 drugs. I guess that if both drugs are given to the same person, it makes a lot of sense to perform simultaneous modeling, because of physiology, a lot of parameters will show covariance. The PK of one drug can therefore partially explain the PK of the other one (and vice versa).

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University at Buffalo/GlaxoSmithKline Post-doctoral

Details: models and computational methods describing the action of various drugs. Fe= llows spend both academic years at the University at Buffalo and the summer= between the two years at GSK R&D site in Pennsylvania. At the completion of the Fellowship, …

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FDA PBPK Workshop

Details: FDA is conducting this workshop as part of the MIDD workshop series. The date, time, location, and other details of the workshop are as follows: Date: November 18, 2019. Time: 8:00 am – 5:00 pm. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503, B and C), Silver Spring, MD 20993

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Fellowship Opportunity

Details: blic health task by making sure that safe and effective drugs are available= to improve the health of people in the United States. As part of the U.S. = Food and Drug Administration (FDA), CDER regulates over the counter and pre= scription drugs, including biological therapeutics and generic drugs. This = work covers more than just medicines.

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NONMEM Users Network Archive: by thread

Details: Upcoming webinar: Using QSP to predict cardiotoxicity caused by cancer drugs Rebecca Baillie (Mon Nov 16 2020 - 11:54:42 EST) APN 2020 - November 18-19 박경수 (Thu Nov 12 2020 - 18:16:05 EST) Pfizer postdoc position in cancer resistance modeling Spilker, Mary (Fri Nov 06 2020 - 11:41:15 EST)

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FDA job opportunities

Details: FDA job opportunities. The Division of Pharmacometrics at FDA is hiring pharmacometricians with responsibilities to develop, evaluate, and report on models that describe compound- or disease-related behaviors using a variety of tools and approaches; to identify opportunities for innovative study designs; and to interact with sponsors during the

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CPT: Pharmacometrics and Systems Pharmacology Now Live

Details: Drugs in Pregnant Women: Verification and Discerning the Site of CYP3A Induction · A Semi-Mechanistic Metabolism Model of CYP3A Substrates = in Pregnancy: Predicting Changes in Midazolam and Nifedipine = Pharmacokinetics · Pharmacokinetic-Pharmacodynamic Modeling of Severity = Levels of

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RE: Clinical Pharmacology Fellowship, North Carolina

Details: and cost of delivering new drugs to market. This fellowship will provide a = broad overview and real-world experience of the drug development process. W= e are seeking self-motivated graduates who are passionate about pursuing a = research …

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BAPKPD Network Special Topics Webinar: Dr. Giacomini, High

Details: 25 drugs met the criteria suggested by FDA DDI guidance to consider a clin= ical DDI study. Further, I will describe the analyses of real world transp= orter biomarkers in data from electronic health records, which suggested th= at several of the drugs actually do cause transporter-mediated DDIs clinica= lly.

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Post-doctoral position in Translational Pharmacology

Details: ndard drugs, can be as long as two years. The current drugs are inefficient= by today's standards and a new, faster-acting and safer treatment is requi= red to reduce the length of therapy and to overcome the threat of drug-resi= stant strains. Until now, the development of new drugs has been slow and th=

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RE: Simultaneous pk model of 2 drugs

Details: From: Lowe, Phil <phil.lowe> Date: Wed, 7 Sep 2016 09:08:19 +0000 Hi Chris, I’ve done it, many years ago, for a drug-drug interaction to estimate an inhibition constant for one drug on the clearance of the other.

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Re: Simultaneous pk model of 2 drugs

Details: If the elimination is first-order for both drugs then its probably computationally quicker to use ADVAN5 (or ADVAN7). This lets you specify separate compartments to account for the input, distribution and elimination of each drug. The input dose is defined by the usual data items (AMT, RATE, II, ADDL,

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Opening Position for Talent Scientist in Clinical

Details: innovative drugs in specific disease areas, and innovators of specific research technologies in pharmacometrics. Currently, one Talent Scientist position is open. She /he will be formal staffs of PUTH and associate/assistant professor of Peking University. The Talent Scientist will be responsible for quantitative system pharmacology

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PKPD manager permanent position at Medicines for Malaria

Details: PKPD manager permanent position at Medicines for Malaria Venture. Medicine team. The position is based in Geneva, Switzerland. (partially remote; currently Covid-remote). and delivering new, effective and affordable antimalarial drugs. malaria-endemic countries. Since its founding in 1999, MMV and partners.

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Roivant Sciences

Details: reducing the time, cost and risk of delivering new drugs to market. Roivant= aims to develop under-resourced or deprioritized drug candidates across th= erapeutic areas of significant medical need. Roivant is rapidly expanding its pipeline and the number of subsidiaries (o= r "Business Units") around therapeutic areas of interest.

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Oncology Pharmacometrician

Details: g the dose-concentration-pharmacological effect relationships of drugs usin= g M&S methodologies, with a focus on Oncology/Hematology. - You will supervise and conduct pharmacometric analysis and contribute to = drug development and the advancement of science both internally and externa= lly (leadership role depending on candidate level).

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Open positions at SERVIER

Details: tive diseases, as well as by our activities in management of marketed drugs= in cardiovascular and metabolism areas and high-quality generic drugs. Our= priorities are pathologies with high medical needs within our areas of exp= ertise. Kind regards, Adrien Tessier Pharmacometrician, Head of Clinical Pharmacometrics

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PhD position in Pharmacometrics/Translational Pharmacology

Details: ndard drugs, can be as long as two years. The current drugs are inefficient= by today's standards and a new, faster-acting and safer treatment is requi= red to reduce the length of therapy and to overcome the threat of drug-resi= stant strains. To achieve this goal, it is essential to characterise the interplay between=

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Upcoming webinar: Using QSP to predict cardiotoxicity

Details: icular drugs were tolerated in one cell line but disrupted dynamics in anot= her cell line. Overall, the work offers new insight into cardiotoxicity caused by TKIs and= illustrates a novel approach for integrating transcriptomic measurements a= nd QSP models to generate experimentally testable, individual-specific pred= ictions.

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PhD and post-doctoral positions in Translational

Details: four drugs that were all developed more than 60 years ago. Treatment lasts = for at least six months and, in the case of resistance to the standard drug= s, can be as long as two years. The current drugs are inefficient by today'= s standards and a new, faster-acting and safer treatment is required to red=

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Job Opportunities at US FDA

Details: drugs. Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients. The Generic Drug User Fee Amendments of (GDUFA) regulatory science program and

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Re: Time-varying bioavailability and reproducibility in

Details: The NONMEM Users Network is maintained by ICON plc.Requests to subscribe to the network should be sent to: [email protected] Once subscribed, you may contribute to the discussion by emailing: [email protected]

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Post-doctoral fellow/PhD position in Translational

Details: four drugs that were all developed more than 60 years ago. Treatment lasts = for at least six months and, in the case of resistance to the standard drug= s, can be as long as two years. The current drugs are inefficient by today'= s standards and a new, faster-acting and safer treatment is required to red=

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Position of a Pharmacometrician at BfArM

Details: The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is a scienti= fic federal higher authority within the portfolio of the Federal Ministry o= f Health (BMG) located in Bonn, Germany The Research Department, Unit "Biostatistics and Special Pharmacokinetics" = is looking for a

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6 months' PKPD modelling position at MMV, Switzerland

Details: The position is for 6 months. (from October to March included) and is based in Geneva, Switzerland. JOB PURPOSE. MMV is a Swiss non-profit foundation whose mission is to reduce the. burden of malaria in disease-endemic countries by discovering, developing. and delivering new, effective and affordable antimalarial drugs.

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Understanding allometry

Details: variability in PK for many drugs (see (Holford, Heo et al. 2013)).The influence of body composition as a predictor of allometric size has fewer examples but it is only by digging below the surface that we can discover new things and evaluate their importance. It is no surprised that over a narrow range (30-100 kg) a linear model

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Post-doctoral fellow/PhD position in Translational

Details: ndard drugs, can be as long as two years. The current drugs are inefficient= by today's standards and a new, faster-acting and safer treatment is requi= red to reduce the length of therapy and to overcome the threat of drug-resi= stant strains. Until now, the development of new drugs has been slow and th=

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Re: DEFDOSE/DEFOBS Required for Many Compartments

Details: > case we want to combine analyses of many drugs (about 20 different drugs > with central/peripheral compartments) and several endpoints. > > In the current model, I'm only fitting the PK of one drug, so only two of > the compartments are enabled: compartments 39 and 42. After the IGNORE

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Quantitative pharmacology modelling position available at

Details: f action understanding of our drugs in all phases of clinical development. = We are part of the Medical Science and Safety area, which is a multifunctio= nal function that embraces several aspects regarding clinical studies, desc= riptive characterisation and biological understanding of the drug action in= human beings. How to apply

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Re: Weird behavior (or poor understanding on my side) of

Details: > for the other drugs, SS=1 will interfere with those. > > I am sure I am misinterpreting something here, but in my understanding, > it should not matter whether I choose SS=1 or SS=2, as long as the dose > is the first one in the dataset SS=1 forgets the past dosing history,

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FDA Launches Crowdsourcing Challenge: Pediatric Research

Details: Office of New Drugs Center for Drug Evaluation and Research U.S. Food and Drug Administration Received on Mon Aug 02 2021 - 10:08:39 EDT. This message: [ Message body] Next message: Hitesh Mistry: "Re: Manchester PBPK" Previous message: Hitesh Mistry: "Manchester PBPK"

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Pfizer US based Pharmacometrics posistions

Details: and development of drugs. It's fascinating, vital work and you could be pa= rt of it. We have made the strategic decision to significantly enhance our= workforce in this discipline because of its critical importance to our org= anization. Therefore we have several new positions for talented individual= s at a number of US sites.

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PK Scientist Opening

Details: e development of drugs and devices that save lives and improve quality of l= ife. Our people are our greatest strength, are at the core of our culture, and t= he driving force behind our success. ICON people have a mission to succeed = and a passion that ensures what we do, we do well. What will you be doing?

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Re: DEFDOSE/DEFOBS Required for Many Compartments

Details: 20 different drugs with central/peripheral compartments) and several endpoints. > In the current model, I'm only fitting the PK of one drug, so only two of the compartments are enabled: compartments 39 and 42. After the IGNORE statement, the data is relatively small wi= th 400 records between 16 subjects, and all the data are in

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RE: Opportunities at FDA/Division Of Pharmacometrics

Details: ith sponsors in the course of investigational new drugs and new drug applic= ations as part of the drug approval process. Minimum requirements include a= n earned Ph.D. or other professional doctorate in PKPD, Statistics, Enginee= ring, or Clinical Pharmacology, hands-on experience with modeling and simul=

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RE: Allometric scaling of renal clearance with estimated

Details: > filtrated and not actively secreted) to predict PK of drugs that > undergo active tubular secretion in patients with decreased renal > function. When glomerular filtration rate drops, the relative > contribution of active tubular secretion to renal clearance increases. > To me, it appears logical that creatinine is a better marker for

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Job Opening at Eli Lilly: Principle Research Scientist-PK

Details: ulatory documents for development and registration of new drugs and line ex= tensions across multiple geographies. This may involve direct interaction w= ith FDA, EMA, PMDA and other regulatory agencies. * Mentor other scientists within the department and in other areas as w= ell as interact, teach and collaborate with academia.

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Full-time tenured academic position in Pharmacometrics (KU

Details: Diverse clinical and non-clinical data sources regarding exposure and/or therapeutic/toxic effects of drugs that are either small molecules or biologicals are available and do not need to be generated. The obtained scientific output will be expected to …

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FDA-M CERSI: Advancing the Development of Pediatric

Details: Office of New Drugs Center for Drug Evaluation and Research U.S. Food and Drug Administration Received on Fri Aug 06 2021 - 15:15:35 EDT. This message: [ Message body] Next message: Robin Michelet: "Time-varying input/flexibility to change input rate on the fly"

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Time-varying bioavailability and reproducibility in NONMEM

Details: Time-varying bioavailability and reproducibility in NONMEM analysis. time-varying bioavailability. Here is a simplified example of my issue: crease (MAXDECR) and a first-order decay constant (LAMBDA). Instead of the =. EVID=1 per administration, no ADDL). ID28 who has a complete PK exploration from day 1 to 28.

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PhD candidate position M&S Neglected Tropical Diseases

Details: ) and pharmacodynamics (PD) of new drugs and drug combinations against the = neglected tropical disease visceral leishmaniasis. The activities will enta= il pharmacometric modelling of PK and PD data to support an ongoing phase I= I/III clinical trial and to prepare for future clinical trials, amongst oth= ers in Eastern Africa and South Asia.

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Post-doc / Researcher in Pharmacometrics

Details: lising clinical and non-clinical data from the Drugs for Neglected Diseases= initiative (DNDi). The main goal of this collaboration between MORU and DN= Di is to optimise the drug development process and provide an evidence-base= d rational for dose selection of novel drugs for neglected tropical disease= s.

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Research Scientist/Sr. Research Scientist

Details: simulation (M&S) of the individual time-course and fate of drugs. We are on course to become the global industry standard, consequently, there is a continuous requirement for high quality people to join us, help in our expansion and share in our success. Certara bases all employment-related decision on merit, taking into

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RE: Assessment of elimination half life of mAb

Details: That we can do. We don't even need an analytical solution, we can eyeball it. We could even get fancy and do it in a population model. C90 - the time it takes for Cmax to decline 90% in 90% of patients. Of course, for nonlinear drugs, C90 only holds for that dose. Change in dose results in a new C90. Just a thought. pete Peter Bonate, PhD

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PhD position in Pharmacometrics at Uppsala University

Details: From: Ulrika Simonsson <ulrika.simonsson> Date: Mon, 2 Sep 2013 22:38:54 +0200 The Pharmacometrics Research Group at Uppsala University invites applications for one PhD position in the field of pharmacometrics. The

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Re: target-mediate model: numerical difficulties

Details: > Quasi-equilibrium pharmacokinetic model for drugs exhibiting target-mediated drug disposition. > Pharm Res. 2005 Oct;22(10):1589-96. Epub 2005 Sep 22. > > Abraham AK, Krzyzanski W, Mager DE. > Partial derivative-based sensitivity analysis of models describing target-mediated drug disposition. > AAPS J. 2007 Jun 8;9(2):E181-9. > >

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