title: Global bioanalytical support.
abstract: With the globalization of drug development, there is an increasing need for global bioanalytical support. Bioanalysis provides pivotal data for toxicokinetic, pharmacokinetic, bioavailability and bioequivalence studies used for regional or global regulatory submission. There are many known complications in building a truly global bioanalytical operation, ranging from lack of global regulatory guidelines and global standard operating procedures to barriers in regional requirements on sample shipping, importation and exportation. The primary objective of this article is to discuss common experiences and challenges facing the biopharmaceutical industry when providing bioanalytical support in a global setting. The key components of global bioanalytical services include the supporting infrastructure, spanning project management, IT support of data management, best practices in bioanalytical method transfer and sample analysis, and comprehensive knowledge of the requirements of bioanalysis guidelines and differences in these guidelines. A case study will highlight best practices for successful management of a global project.
authors: Frontage Laboratories, Inc., 700 Pennsylvania Drive, Exton, PA 19341, USA.
authors: Zhongping
authors: Z
authors: John Lin
authors: Tianyi
authors: T
authors: Zhang
authors: Stephanie
authors: S
authors: Pasas-Farmer
authors: Stephen D
authors: SD
authors: Brooks
authors: Michael
authors: M
authors: Moyer
authors: Ron
authors: R
authors: Connolly
mesh_terms: D004341:Drug Evaluation / Q000592:standards; D019451:Information Management / Q000592:standards; D007753:Laboratories / Q000458:organization & administration; D020416:Outsourced Services / Q000458:organization & administration; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000378:metabolism* / Q000592:standards; D011786:Quality Control
chemical_list: D004364:Pharmaceutical Preparations