yt:channel:UCj3YZgKXa8vwRXgvD2dfEcQ UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2012-04-03T21:19:47+00:00 yt:video:7WJUHANr7Eo 7WJUHANr7Eo UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2017-07-13T20:04:47+00:00 2017-07-20T13:20:00+00:00 PML School: Turnover model 1 - Repeated dosing PML School: Turnover model 1 - Repeated dosing Presenter: Chris Mehl yt:video:FOUy0g5vzXg FOUy0g5vzXg UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2017-06-22T18:25:58+00:00 2017-06-26T08:57:49+00:00 Using Modeling and Simulation to Combat Tuberculosis: A Global Health Priority Tuberculosis (TB) is a deadly disease, a principal cause of death by infectious disease, and the leading cause of mortality for HIV+ patients. Most available TB drugs are more than 40 years old, have significant side effects and drug interactions, and require a long treatment period. Furthermore, these drugs are becoming less effective as TB strains grow increasingly drug resistant. New tools are desperately needed to help TB drug developers combat this deadly disease. The Critical Path to TB Drug Regimens (CPTR) Initiative, in partnership with Certara, developed a TB-specific set of lung and granuloma models, together with a library of drug and metabolite files. These models and library files are implemented in Certara’s Simcyp Simulator physiologically-based pharmacokinetic (PBPK) platform, which helps optimize the design of clinical studies for multiple indications and has been widely adopted by industry and regulators. Watch this webinar with C-Path’s Dr. Klaus Romero to learn how they integrated these components into the latest version of the Simcyp Simulator to establish a robust resource that will help development teams and regulators evaluate the safety and efficacy of novel anti-TB drug regimens. yt:video:eei5APncAwU eei5APncAwU UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2017-06-22T15:28:55+00:00 2017-06-23T14:31:29+00:00 PML School: Turnover model 4 - IV infusions PML School: Turnover model 4 - IV infusions By: Bernd Wendt yt:video:iB7oTg9N1Ls iB7oTg9N1Ls UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2017-06-08T19:15:13+00:00 2017-06-14T11:44:36+00:00 PML School: Turnover Model 1 IV bolus dosing Turnover Model 1: IV Bolus Dosing Model Warfarin-PCA interaction Presenter: Chris Mehl yt:video:ZbY0Is3YpfA ZbY0Is3YpfA UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2017-06-01T18:32:59+00:00 2017-06-07T15:36:20+00:00 Obeticholic Acid: From PK Model to Drug Label Obeticholic acid (OCA) is a selective and potent farnesoid X receptor (FXR) agonist in development for the treatment of primary biliary cholangitis/cirrhosis (PBC), nonalcoholic steatohepatitis (NASH), and other liver diseases. OCA is the 6α-ethyl derivative of chenodeoxycholic acid (CDCA) and has similar pharmacokinetic (PK) properties. The results from a hepatic impairment clinical study revealed that systemic OCA concentrations increased with moderate and severe hepatic impairment. These results are consistent with previously reported studies wherein plasma endogenous bile acids were elevated in patients with hepatic impairment, but liver concentrations were only modestly increased. Accordingly, an alternate dosing regimen was developed for OCA based on modeling and simulations for patients with moderate and severe hepatic impairment to mitigate tolerability concerns with high systemic exposures. Watch this webinar with Jeffrey Edwards to learn how he used physiologic pharmacokinetic modeling to understand the relationship between systemic and hepatic exposure of OCA in patients with and without hepatic impairment. By watching this webinar, you will learn how pharmacokinetic modeling can support optimal dosing for patients with organ impairment and facilitate regulatory approval. yt:video:4NAiwt3Bk5U 4NAiwt3Bk5U UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2017-05-24T19:26:31+00:00 2017-05-24T21:18:08+00:00 Avoiding Pitfalls in Plain Language Summaries of Clinical Trial Results In recent years, pharmaceutical companies have become increasingly aware of the regulatory and ethical mandates to develop and disseminate plain language summaries of clinical trial results. However, awareness alone doesn’t confer the ability to develop scientifically accurate, non-promotional, and easy to understand plain language summaries. When the results of your clinical trials become available, will you be ready to communicate them to patients in a timely manner? Do you have the experience and expertise needed to comply with the latest guidance from regulatory bodies and plain language standards? CISCRP and Synchrogenix have partnered to offer a program to meet upcoming reporting requirements, increase public transparency and trust, and engage patient communities. In this webinar, Tatyana Wanderer and Behtash Bahador provided insights and recommendations gained from working with leading sponsors on portfolio-wide implementation and pilot programs to create plain language summaries of clinical trial results. Whether you’re just starting program planning or simply need help developing compliant and patient-friendly summaries of clinical trial results watch this archived webinar to gain keys insights on what it takes to develop a plain language summary program that meets all your needs. yt:video:UfbhJ92rbi0 UfbhJ92rbi0 UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2017-05-16T19:20:31+00:00 2017-05-19T08:12:47+00:00 Modeling PKPD Systems with Distributed Delays Systems with distributed delays are extensions of systems with discrete delays where a single lag time is represented by a distribution of lag times. Distributed absorption times for orally administered drugs serve as an example of a pharmacokinetic (PK) system with distributed delays. Another example is a hematopoietic cell population with distributed lifespans. The topic of this webinar was to introduce mathematical tools to model pharmacokinetic/pharmacodynamic (PK/PD) systems with distributed delays. These models were implemented in Phoenix NLME by means of the delay() operator. A distributed delay version of the transit compartment model for oral drug absorption was provided. A distributed lifespan PD model of RBC production was also discussed. yt:video:rSjKMbF_-q0 rSjKMbF_-q0 UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2017-05-11T17:09:43+00:00 2017-05-11T18:48:43+00:00 PML School: Effect compartment III - IV infusion Effect Compartment III: IV infusion Model response-time data with a link-model Presenter: Bernd Wendt yt:video:oBbN2SDsqko oBbN2SDsqko UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2017-04-27T16:45:35+00:00 2017-04-27T18:29:03+00:00 PML School: Modeling Inhibition of Enzyme Activity by Means of Turnover Construction Modeling Inhibition of Enzyme Activity by Means of Turnover Construction of a mechanistic turnover model Presenter: Chris Mehl yt:video:tlYZQqPKB8E tlYZQqPKB8E UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2017-04-26T18:22:04+00:00 2017-07-13T08:51:29+00:00 Mechanistic modeling of genome scale molecular interaction networks Physiologically-based Pharmacokinetic (PBPK) modeling has become the industry standard for predicting drug-drug interactions, formulation effects, and pharmacokinetics in human populations. As a bottom-up, literature-based, mechanistic computer simulation approach, it shares general methodology with the computational systems biology, where molecular biology knowledge is assimilated into molecular network models. In particular, reconstruction of Genome Scale Metabolic Networks (GSMNs) has led to mechanistic models incorporating a whole set of metabolic enzymes expressed in human tissues. Moreover, dynamic models of the expression of key drug metabolism enzymes are available. Currently, PBPK models account for about 20 genes involved in drug metabolism. Integrating PBPK with GSMN and gene regulation models can extend the scope of mechanistic pharmacokinetic modeling to thousands of genes as well as the complex interactions of drug metabolism enzymes with endogenous metabolites such as cortisol. In this webinar, Dr. Andrzej Kierzek demonstrated how integrating human hepatocyte GSMN, gene regulation of CYP3A4, and a basic PBPK model can identify genes influencing the production of toxic metabolites and simulate kinetics of this metabolite as a function of cortisol and Pregnane X receptor (PXR) ligands. yt:video:O-RplTAUD1M O-RplTAUD1M UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2017-04-24T17:19:47+00:00 2017-04-27T16:48:31+00:00 PML School: Analysis of a Tissue Growth/Kill Model Analyze a tumor cell kill model after acute dosing Presenter: Bernd Wendt yt:video:4aO2lOFhQYI 4aO2lOFhQYI UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2017-04-21T20:25:54+00:00 2017-04-27T16:48:58+00:00 PML School: Analysis and Comparison of Link, Turnover and Receptor Binding Models Fit a link-, turnover- and receptor binding model to data yt:video:dL2x2dd-kQM dL2x2dd-kQM UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2017-04-21T19:11:47+00:00 2017-04-27T16:49:20+00:00 PML School: One-compartment 1st and 0-order Input Fit and discriminate between first and zero-order absorption models Presenter: Chris Mehl yt:video:vXybn79ihjE vXybn79ihjE UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2017-04-21T18:23:14+00:00 2017-04-27T16:49:44+00:00 PML School: Sigmoidal Concentration-response Models Apply Gompertz, Weibull, Richards, Morgan-Mercer-Flodin, Hill and logistic models Presenter: Chris Mehl yt:video:kKP3Mw0gjy8 kKP3Mw0gjy8 UCj3YZgKXa8vwRXgvD2dfEcQ Certara https://www.youtube.com/channel/UCj3YZgKXa8vwRXgvD2dfEcQ 2017-04-21T17:40:08+00:00 2017-06-08T23:04:06+00:00 PML School: Turnover III - Nonlinear Disposition Characterize turnover of an endogenous compound Presenter: Bernd Wendt