title: Integration of biostatistics and pharmacometrics computing platforms for efficient and reproducible PK/PD analysis: a case study.
abstract: Results of pharmacometric analyses influence high-level decisions such as clinical trial design, drug approval, and labeling. Key challenges for timely delivery of pharmacometric analyses are the data assembly process and tracking and documenting the modeling process and results. Since clinical efficacy and safety data typically reside in the biostatistics computing area, an integrated computing platform for pharmacometric and biostatistical analyses would be ideal. A case study is presented integrating a pharmacometric modeling platform into an existing statistical computing environment (SCE). The feasibility and specific configurations of running common PK/PD programs such as NONMEM and R inside of the SCE are provided. The case study provides an example of an integrated repository that facilitates efficient data assembly for pharmacometrics analyses. The proposed platform encourages a good pharmacometrics working practice to maintain transparency, traceability, and reproducibility of PK/PD models and associated data in supporting drug development and regulatory decisions.
authors.affiliation: Onyx Pharmaceuticals, Inc., South San Francisco, CA, USA.
authors.forename: Ying C
authors.initials: YC
authors.lastname: Ou
authors.forename: Arthur
authors.initials: A
authors.lastname: Lo
authors.forename: Brian
authors.initials: B
authors.lastname: Lee
authors.forename: Phillip
authors.initials: P
authors.lastname: Liu
authors.forename: Karen
authors.initials: K
authors.lastname: Kimura
authors.forename: Charisse
authors.initials: C
authors.lastname: Eary
authors.forename: Alan
authors.initials: A
authors.lastname: Hopkins
mesh_terms: D000617:Aminoglycosides / Q000097:blood / Q000493:pharmacokinetics; D000900:Anti-Bacterial Agents / Q000097:blood / Q000493:pharmacokinetics; D056808:Biostatistics / Q000379:methods*; D003198:Computer Simulation; D003428:Cross Infection / Q000097:blood / Q000188:drug therapy; D006801:Humans; D000077427:Lipoglycopeptides; D008954:Models, Biological; D010601:Pharmacology, Clinical / Q000379:methods*; D018410:Pneumonia, Bacterial / Q000097:blood / Q000188:drug therapy; D012984:Software
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000077427:Lipoglycopeptides; C487637:telavancin
keywords: NONMEM; R; pharmacometrics computing platforms; statistical computing environment (SCE)