非GLP探索研究サポート

非GLP探索研究サポート

当社の探索チームは、下記に記載したプロジェクトの非GLPサンプルハイスループット分析に特化しています。

  • スピードが最優先される分析
  • Pre-INDの探索研究
  • N-in-one
  • CACO-2
  • タンパク結合
  • 安定性予備検討

その他の特注分析に関しては、お客様と当社プロジェクトマネージャ－との協議の上、検討致します。

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.

Discovery Bioanalytical Assay Level 1 (DBA 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.

Discovery Bioanalytical Assay Level 2 (DBA 2)
Applicable to the later stages of screening where the objective is to provide data that supports decisions requiring 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.

Discovery Bioanalytical Assay Level 3 (DBA 3)
Applicable to the later stages of screening where the objective is to provide data that supports decisions equiring 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.

Discovery Bioanalytical Assay Level 4 (Good Bioanalytical Practice, DBA 4)
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.

Study Types

  • PK/PD
  • Pilot-Toxicology
  • Metabolic stability, protein binding, others if requested

Type of Compounds

  • Small organic compounds (MW 200 - 1,400)
  • Peptides (AA residues < 50)

Species and Type of Samples

  • Species: rodent (mouse, rat), rabbit, pig, dog, monkey and human
  • Biofluids: plasma, serum, whole blood, CSF, BALF, bile and urine
  • Tissues: brain, ear, nose, lung, artery, liver, muscle, skin, intestine, paws, fat, kidney, different ocular tissues, prostate, testes, ovary, spleen, and lymph nodes
  • Residue dosing solutions
  • Device analysis (e.g., drug coated stents).