Phoenix 8.1, the newest version of Certara’s innovative PK/PD modeling and simulation software used globally by researchers and drug developers in pharma, academia, and regulatory agencies, will be available on 2018年6月15日. Major enhancements were introduced in the Phoenix workbench last year. And as an ongoing commitment to support compliance and efficiency, many features and functions in our newest version reflect valuable feedback from our Phoenix community. A recent webinar reviewed and demonstrated the innovations made to Phoenix WinNonlin and NLME, and how to get the most out of Phoenix capabilities. This blog post summarizes the key new features and enhancements in Phoenix 8.1—for more detail, watch the webinar.
Phoenixの新ツール、Ratios and Differences ツール
Calculating ratios of PK parameters is a common post-processing step for study reports and interpreting results. These calculations are typically required for pre-clinical toxicokinetic studies, clinical Phase 1–2 multiple dose studies, and dose range finding studies. Determining average renal clearance, accumulation ratios, gender differences, parent to metabolite exposure ratios, dose proportionality, exposure ratios for food effects, drug-drug interactions, and relative bioavailability is cumbersome and time-consuming, generally requiring 10–15 steps to calculate these PK ratios. The NCA Ratios and Differences tool in Phoenix WinNonlin is a new tool for data processing and preparation that simplifies the ratios calculations from one to two input worksheets. Report-ready tables can be easily created from this tool output. Automate these ratios calculation and tables generation steps by adding these objects to your workflow.
New Descriptive Statistics and enhanced charting capabilities
Descriptive Statistics have been updated to include new statistics including range, min and max when weighting is used, sums or Geometric SD, user-specified percentiles, in addition to an option to select statistics for output. グラフ作成機能が強化され、各グラフをさらに柔軟かつカスタマイズして作成することが可能になりました。These include the ability to order the presentation of categorical plots on x-axis and order of legend labels in XY and categorical plots, utilize the offset function left or right on X-axis, add line to XY (X-categorical), and more.
ソフトウェアバリデーションの高速化と効率化
Enhancements made to the Phoenix Validation Suite for WinNonlin streamline the validation process. The Validation Suite is now integrated into Phoenix and can be accessed without having to install a separate application. Phoenix以外のアプリケーションを実行しながら、Phoenix WinNonlinの完全なバリデーションを30分以内に完了します。Validation Suite for WinNonlin provides locked PDF reports with links to saved reference output files, user output files, and difference files. バリデーション文書テンプレートが更新され、最新のICH E6 GCP (R2) などの規制ガイドラインが要求するコンピュータシステムバリデーションの要件に準拠しています。To learn tips and guidance from quality assurance experts on how to streamline validating new or upgraded software, and to get a better understanding on common validation pitfalls and ways to avoid them, watch an archived webinar by Noreen Muscat from QACV Consulting and Allan Michaels from Certara Phoenix Technology Services. The speakers covered topics from Good Automated Manufacturing Practice guidelines (GAMP® 5) and CFR Part 11 compliance to robust reporting using Validation Suite for WinNonlin.
Visual Predictive Check
Visual Predictive Check (VPC) is a graphical comparison and analysis of observations and simulated predictions1. VPC in Phoenix NLME now provides broader applicability and flexibility for users. この機能強化により、定量下限値未満 (Below Quantification Limit、BQL) のデータを含む連続型データや、カテゴリー型データ、単一のTime-to-Event型データ、そしてカウント型データなどを含む離散型の観測値など多様なデータに対して、個別にVPCプロットを生成することが可能です。その他のVPCの改善点として、VPCとシミュレーションの実行モードの分離、カテゴリー型共変量のVPCにおける層別化などが挙げられます。
New Certara Professional Certification—Phoenix WinNonlin Analyst
The new launch of Phoenix also coincides with the new Certara Professional Certification program which provides online accreditation of user competency and proficiency of PK/PD data analysis using Certara software such as Phoenix WinNonlin.
Earning a Certara Professional certification—after passing a rigorous exam—validates that you have the necessary skills to perform PK/PD analysis using the industry-leading software. The first certification—Certara Certified NCA Analyst using Phoenix WinNonlin Version 8.0/8.1—will be available later this month. Stay tuned for updates and announcements coming shortly.
なお、認定は 3 年間有効です。
参照文献
[1] Nguyen THT, Mouksassi M-S, Holford N, et al. (2017)。Model evaluation of continuous data pharmacometric models: Metrics and graphics. CPT Pharmacometrics Syst Pharmacol, 6, 87–109.
Want to learn more about the new features in Phoenix 8.1 and Certara Professional Certification? Be sure to check out this webinar I did with my colleagues Nathan Teuscher and Ana Henry.
