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Population Modeling of Modified Risk Tobacco Products

E-cigarette (e-cig) sales have surged in recent years. E-cigs, which deliver nicotine without carcinogenic tar, hold the promise to save the lives of many smokers who switch to them. However, their potential risks include failure to quit cigarettes (dual use), increased initiation to nicotine products among youth, relapse of former smokers to e-cigs, and e-cigs […]

Speaker(s): Bill Poland, Jason Pirone
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Improve Your Success Rate in Costly Bioequivalence Studies with IVIVC

Are you looking to support a bio waver for changes in manufacturing site, raw material suppliers and minor changes in formulation with Level A IVIVC? In this webinar, Dr. Terry Shepard of the Medicines and Healthcare product Regulatory Agency (MHRA) discussed the regulatory applications of IVIVC including the specification settings and biowaivers. She also explained […]

Speaker(s): Venkateswari Muthukrishnan
Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, PK/PD Modeling & Simulation
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How to Use Phoenix RSABE Templates

Traditional average bioequivalence (ABE) methodology requires prohibitively large sample sizes when used with highly variable drugs and drug products (HVDs/HVDPs), which are defined as products with intra-subject CV% of the reference greater than 30%. This increases the expense of BE studies, places more study subjects at risk, and ultimately limits the availability of generics. Reference-scaled […]

Speaker(s): Ana Henry
Solution: Model-informed Drug Development, PK/PD Modeling & Simulation
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How Do We Translate Pre-clinical and Clinical Research into Drug Labeling?

The number of submissions to the FDA involving physiologically-based pharmacokinetic (PBPK) modeling has increased significantly over the past few years. PBPK modeling can be applied in drug discovery and development from the early stages prior to lead development where limited data are available as well as in early to late drug development. There are now […]

Speaker(s): Karen Rowland Yeo
Solution: Model-informed Drug Development, PBPK Modeling & Simulation
Therapeutic Area: Central Nervous System, Oncology/Hematology, Rare/Orphan Disease
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Phoenix WinNonlin Workflows: Estimate Pre-clinical PK/PD Parameters for Anti-cancer Agents

Are you utilizing Phoenix WinNonlin to effectively evaluate the safety, efficacy and target specificity of investigational drugs? Are you building workflows from scratch for every new drug compound? Learn how to use Phoenix templates to accelerate characterizing a drug’s PK/PD profile. In this webinar, Certara’s Dr. Bernd Wendt demonstrated how Phoenix WinNonlin has been used […]

Speaker(s): Bernd Wendt
Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, PK/PD Modeling & Simulation
Therapeutic Area: Oncology/Hematology
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Phoenix WinNonlin Validation Suite: Decrease the Time and Cost of Your Validation

Do you or your company spend weeks or months manually performing the necessary steps for software validation? In this webinar, the Certara team discussed the requirements for computer system validation, how it’s performed, and how Certara’s validation products can significantly reduce the time, resources, and cost of the on-site validation of your Phoenix WinNonlin computer […]

Speaker(s): Debra Fontana, Linda Hughes
Solution: Drug Development & Regulatory Strategy, PK/PD Modeling & Simulation
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PBPK Is Ready for NDA- and IND-related Submissions! But Are YOU Ready for PBPK?

Recently, the US Food and Drug Administration held a workshop on “Application of Physiologically-based Pharmacokinetic (PBPK) Modeling to Support Dose Selection.” With the FDA’s intention to maintain an efficient review process for human drug and biological products, PBPK models may be useful for assessing risk during drug development. Indeed, PBPK models have increasingly been applied […]

Speaker(s): Amin Rostami-Hodjegan
Solution: Model-informed Drug Development, PBPK Modeling & Simulation
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A Student’s Perspective on Using Phoenix NLME for PopPK Analysis of an Intranasal Combination Drug

The pharmacokinetic dispositions and the underlying variability of Kovacaine Mist®, a combination product containing oxymetazoline and tetracaine, were investigated by nonlinear mixed effects modeling using Phoenix® NLME. The project utilized the different plugins in the Phoenix platform allowing all steps of model development right from data setup to producing publication quality graphs in a single […]

Speaker(s): Tim Cacek
Solution: Model-informed Drug Development, PK/PD Modeling & Simulation
Therapeutic Area: Central Nervous System
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Quantitative and Systems Pharmacology Approaches for the Development of Oncology Drugs

Modeling and simulation of the absorption, distribution, metabolism and elimination (ADME) of a drug, using a mechanistic approach, can help to predict the potential exposure of a drug at a given dose in the population of interest. The development of in vitro – in vivo extrapolation (IVIVE) relating to ADME to predict pharmacokinetic (PK) parameters […]

Speaker(s): Karen Rowland Yeo
Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, PBPK Modeling & Simulation
Therapeutic Area: Oncology/Hematology
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How Using Phoenix Can Halve the Time Spent on Pre-clinical PK Analyses

WinNonlin was launched in 1986 and has become the de facto standard for NCA and PK/PD modeling. Four years ago, Phoenix WinNonlin was launched to very positive response from the scientific community. As we worked closely with the WinNonlin user community to design the next generation Phoenix platform, we realized that users were spending much […]

Speaker(s): Christopher Mehl
Solution: Model-informed Drug Development, PK/PD Modeling & Simulation
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