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Getting Results Faster – Supporting Physicians and Pharmacists with Biosimulation Technologies

Certara’s Phoenix biosimulation software platform is widely used for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and population PK analysis. Recently, we have seen how Certara software helps customers accelerate collaboration across their divisions and groups for better clinical results. Today, we interviewed Sun Hua, Associate Chief Pharmacist at Yijishan Hospital, Drug Evaluation Center, Wannan Medical College, China to understand how this technology impacted her research.

How does Certara’s Phoenix software and technology support your research?

Phoenix software is simple to use, provides faster results because of its user-friendly interface, and enables us to trust the results it generates. Other hospitals, industrial sectors, and regulatory agencies use Phoenix software as well. We have incorporated analysis data obtained using Phoenix software in several of our published papers.

What is your plan for pharmacometrics/biosimulation technologies in the future?
Do you have any specific goals?

We have planned to work with the Pharmacy Department in our hospital, using population pharmacokinetics for Therapeutic Drug Monitoring (TDM) to fulfill clinical needs.

We would like to solve the “last mile” challenge wherein many first-line physicians and pharmacists do not have extra energy or time to dedicate to optimizing clinical medications by applying pharmacokinetics/pharmacometrics to clinical practice for quasi-therapeutic treatment. Therefore, we will:

  1. Collaborate with physicians and pharmacists in other departments to tackle data processing and analysis challenges.
  2. Present to them pharmacokinetics/pharmacometrics formulas and methods commonly used in actual clinical practice in a more accessible way. For example, we will translate formulas into SAS codes and send to relevant statistical departments.

What are the benefits of studying pharmacokinetics for university students looking for a major/career?

Students in our department are currently seeking jobs in two main fields. One is hospital positions, for which a good grasp of pharmacokinetics/pharmacometrics is a must; the other is clinical research associate (CRA) positions in contract research organizations (CROs), a path that an increasing number of students are taking. Thus, they must first complete relevant courses in pharmacokinetics, clinical phase I studies, and drug registration, among others. We are also currently offering an elective course of quantitative pharmacology, which has been very well-received.

Companies tend to prefer students with a strong grasp of pharmacokinetics and pharmacometrics during the recruiting process, since such expertise will qualify them for real-world projects and help them address real-world issues.

Please highlight one of your latest publications.

We recently published a paper “Population pharmacokinetics of roflumilast and its metabolites in Chinese healthy people”, which is based on our analysis using Phoenix NLME, Certara’s pop PK/PD modeling and simulation tool. In this study, we analyzed the “RFM (roflumilast)” and its “metabolites (RFN, roflumilast-N-oxide)”. We quickly completed modeling using the userfriendly model structure schematic editor in Phoenix NLME, and we adopted the following model structure.

For RFM, we used a first order-rate uptake two-compartment linear elimination model with absorption delays, and for RFN, we used a first order-rate uptake one-compartment linear elimination model, and then linked the two models in series. We tested a range of variables using this model and discovered a correlation between body mass index (BMI) and Q (blood flow).

This is the first research to look at the pharmacokinetics of roflumilast and its metabolites in a healthy Chinese population. It is an excellent starting point for further research on roflumilast.

About , Yijishan Hospital, Drug Evaluation Center, Wannan Medical College

Yijishan Hospital, the first hospital affiliated with Wan Nan Medical College, which was formerly known as Wuhu General Hospital, was founded by the Methodist Church in 1888. Founded 131 years ago, this was the first tertiary general hospital in Anhui Province, China. The hospital covers 270 acres and has 2,320 beds and 2,548 employees. Our team consists of 24 members and runs departments such as the pharmacokinetic analysis laboratory and the mathematical pharmacology research laboratory. We are currently conducting academic research in areas such as DDI, population pharmacokinetics, and bioequivalence methodology.

About the Interviewee

Sun Hua is an Associate Chief Pharmacist at the Drug Evaluation Center, Yijishan Hospital, Wannan Medical College, China. She has been involved in the clinical research of new drugs and has organized and participated in nearly two hundred bioequivalence and clinical pharmacokinetic studies of new drugs. Over the years, she has specialized in protocol design and biostatistics of bioequivalence studies with complex formulations. Sun Hua’s recent research interests include clinical individualization studies with the guidance of quantitative pharmacology and interactive studies on the combination of Chinese and Western drugs.

Recent Publications:

[1]孙华, et al.”有缺失数据的生物等效性评价的考虑要点.” 中国临床药理学杂志 36.18(2020):2891-2895. doi:10.13699/j.

[2]吴敏, 过怿赟,and 谢海棠.”乳腺癌患者体内他莫昔芬的群体药代动力学研究.” 中国临床药理学与治疗学

[3]徐毛迪, 吴子静,and 谢海棠.”窄治疗指数药物的生物等效性评价进展.” 中国临床药理学与治疗学 22.11(2017):1201-

[4]孙华, 梁大虎,and 谢海棠.”两阶段生物等效性研究的试验设计及关注要点.” 药物评价研究 40.05(2017):593-599.

[5]何春远, 孙华,and 谢海棠.”高变异药物生物等效性试验及量化评价.” 中国临床药理学与治疗学 21.07(2016):721-730.

[6]梁大虎, et al.”HPLC-MS/MS法测定人血浆中华法林对映体浓度及其临床应用.”药物分析杂志 40.02(2020):232-239. doi:

[7]李相鸿, et al.”HPLC-MS/MS法测定人血浆中右旋雷贝拉唑和左旋雷贝拉唑浓度及其人体药动学研究.” 中国新药杂志
30.01(2021):43-49. doi:CNKI:SUN:ZXYZ.0.2021-01-008.

[8]Wu, Zijing, et al. “A Comparative Pharmacokinetic Study of Schisandrol B After Oral Administration of Schisandrol B
Monomer and Schisandra chinensis Extract.” Current Pharmaceutical Analysis 17.2 (2021): 273-284.

[9]Liang, Dahu, et al. “Pharmacokinetic Properties of S-oxiracetam After Single and Multiple Intravenous Infusions in Healthy Volunteers.” European Journal of Drug Metabolism and Pharmacokinetics (2021): 1-13.

[10]Li, Chao, et al. “Evaluation of the Influence of Zhenwu Tang on the Pharmacokinetics of Digoxin in Rats Using HPLC-MS/MS.” Evidence-Based Complementary and Alternative Medicine 2021 (2021).

[11]Liang, Dahu, et al. “HPLC-MS/MS-mediated analysis of the pharmacokinetics, bioavailability, and tissue distribution of schisandrol B in rats.” International Journal of Analytical Chemistry 2021 (2021).

About the author

By: Certara