Clinical (GCP) Bioanalysis

Method development/validation an bioanalysis by HPLC-UV or UPLC/MS/MS:

  • New Chemical Entity (NCE) Phase I pharmacokinetic studies on healthy volunteers
  • Bioequivalence studies

GLP Bioanalysis

  • GLP method development by HPLC or UPLC/MS/MS
  • Solutions to clients analytical bottlenecks by providing GLP bioanalysis support for client's GLP samples.
  • Partnership with EU based companies specialized in GLP animal dosing, allows us to offer a complete preclinical PK and Toxicokinetic GLP service in all non-human species, with NiKem providing the GLP bioanalysis and project co-ordination

 

 

NiKem Research Services: Focused on Drug Discovery

Our Services: GLP and GCP Bioanalysis

A new GLP and GCP bioanalytical laboratory complements our discovery facilities

As compounds progress through the development process, GLP certified data becomes mandatory. NiKem Research has always prided itself on the high quality, cost-effective bioanalytical support that it provides for both for its in vitro ADME(T) and in vivo PK services. We are now pleased to have been granted licenses allowing us to offer both GLP and Clinical (GCP) Bioanalysis services to support our clients preclinical PK and toxicology studies and clinical studies Our new capabilities allow us to analyse biological samples from all preclinical species and from clinical studies

For more information and prices please contact: info@nikemresearch.com