@misc{GrisicHuisingaReinischetal.2017,
  author    = {Grisic, Ana-Marija and Huisinga, Wilhelm and Reinisch, W. and Kloft, Charlotte},
  title     = {P485 Dosing infliximab in Crohn's disease},
  series = {Journal of Crohn's and Colitis},
  volume    = {11},
  journal   = {Journal of Crohn's and Colitis},
  number    = {1},
  publisher = {Oxford Univ. Press},
  address   = {Oxford},
  issn      = {1873-9946},
  doi       = {10.1093/ecco-jcc/jjx002.609},
  pages     = {S325 -- S326},
  year      = {2017},
  abstract  = {Background: Infliximab (IFX), an anti-TNF monoclonal antibody approved for the treatment of inflammatory bowel disease, is dosed per kg body weight (BW). However, the rationale for body size adjustment has not been unequivocally demonstrated [1], and first attempts to improve IFX therapy have been undertaken [2]. The aim of our study was to assess the impact of different dosing strategies (i.e. body size-adjusted and fixed dosing) on drug exposure and pharmacokinetic (PK) target attainment. For this purpose, a comprehensive simulation study was performed, using patient characteristics (n=116) from an in-house clinical database. Methods: IFX concentration-time profiles of 1000 virtual, clinically representative patients were generated using a previously published PK model for IFX in patients with Crohn's disease [3]. For each patient 1000 profiles accounting for PK variability were considered. The IFX exposure during maintenance treatment after the following dosing strategies was compared: i) fixed dose, and per ii) BW, iii) lean BW (LBW), iv) body surface area (BSA), v) height (HT), vi) body mass index (BMI) and vii) fat-free mass (FFM)). For each dosing strategy the variability in maximum concentration Cmax, minimum concentration Cmin (= C8weeks) and area under the concentration-time curve (AUC), as well as percent of patients achieving the PK target, Cmin=3 μg/mL [4] were assessed. Results: For all dosing strategies the variability of Cmin (CV ≈110\%) was highest, compared to Cmax and AUC, and was of similar extent regardless of dosing strategy. The proportion of patients reaching the PK target (≈⅓ was approximately equal for all dosing strategies.},
  language  = {en}
}
@misc{KrauseKloftHuisingaetal.2019,
  author    = {Krause, Andreas and Kloft, Charlotte and Huisinga, Wilhelm and Karlsson, Mats and Pinheiro, Jos{\´e} and Bies, Robert and Rogers, James and Mentr{\´e}, France and Musser, Bret J.},
  title     = {Comment on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development},
  series = {Pharmaceutical statistics : the journal of applied statistics in the pharmaceutical industry},
  volume    = {18},
  journal   = {Pharmaceutical statistics : the journal of applied statistics in the pharmaceutical industry},
  number    = {3},
  publisher = {Wiley},
  address   = {Hoboken},
  organization    = {ASA Special Interest Grp Stat Phar ASA Special Interest Grp Stat Phar},
  issn      = {1539-1604},
  pages     = {278 -- 281},
  year      = {2019},
  language  = {en}
}
@misc{WichaKeesSolmsetal.2015,
  author    = {Wicha, Sebastian G. and Kees, Martin G. and Solms, Alexander Maximilian and Minichmayr, Iris K. and Kratzer, Alexander and Kloft, Charlotte},
  title     = {TDMx: A novel web-based open-access support tool for optimising antimicrobial dosing regimens in clinical routine},
  series = {International journal of antimicrobial agents},
  volume    = {45},
  journal   = {International journal of antimicrobial agents},
  number    = {4},
  publisher = {Elsevier},
  address   = {Amsterdam},
  issn      = {0924-8579},
  doi       = {10.1016/j.ijantimicag.2014.12.010},
  pages     = {442 -- 444},
  year      = {2015},
  language  = {en}
}