Non-GLP Discovery Support

Non-GLP Discovery Support

Tandem Labs' discovery team specializes in high-throughput analysis of non-GLP samples. Such projects include:

  • Time-critical analyses
  • Pre-IND discovery studies
  • N-in-one
  • CACO-2
  • Protein-binding
  • Stability screening

and other custom-screening procedures to be determined in consultation with the client and our Tandem Labs' project manager.

Non-GLP PK/PD Discovery Bioanalysis Assay Categories

The following assay categories allow our scientists to provide clients with quality data satisfying experimental objectives in the shortest time with minimal transactional overhead.

Research Grade Assay Level 1 (RGA 1)
Applicable to the early stage screening of many compounds where the objective is to provide a coarse filter of compound PK/PD, e.g., the rank ordering of compounds.

  • Assay acceptance criteria designed to detect differences between compounds of approximately ≥ two-fold.
  • Experimental approach driven by need for rapid data turnaround times, producing data of sufficient quality to satisfy experimental objective.

Research Grade Assay Level 2 (RGA 2)
Applicable to the later stages of screening where the objective is to provide data that supports the decision to require information of finer granularity and/or improved confidence, e.g., candidate evaluation among limited compounds, formulation assessments, etc.

  • Assay acceptance criteria designed to detect more subtle differences between compounds, e.g., differences of approximately ± 50% between compounds or across studies.
  • Experimental approach driven by improving assay performance and confidence level of the resulting data while still providing acceptable turnaround times.

Research Grade Assay Level 3 (Good Bioanalytical Practice, RGA 3)
Applicable to the latest stages of compound assessment or to bridging studies needed to support non-safety related, IND submission, e.g., definitive PK/PD studies defining dose levels in GLP nonclinical safety studies. The experimental objectives at this level require assay performance at industry standards but do not require GLP assay validation and application.