• Highly reproducible, accurate data – validated and used by pharmaceutical, biotechnology, agrochemical and cosmetics companies, and academic organizations.
  • Delivery of data is within 10 weeks at reception of compounds, to fit in with the make-test timelines in drug discovery. A number of different reporting options are available.
  • Attention to good quality customer care, with highly trained Principal Scientists on hand to explain results and suggest the most appropriate experimental strategy.
  • Flexibility – studies can be tailored to our customers’ specific requirements.
  • Regulations – our services maintain and comply with regulatory guidelines providing constant confidence in the data.

 

Our facility has passed evaluations by a range of different companies and organizations who now routinely use our services to provide support to their programs.

 

 

 

Please note that GLP is NOT required for:

  • Efficacy studies, whether in vitro or in vivo. In fact, the IND application has no requirement at all for mechanism of action or efficacy studies.
  • In vitro studies, including :
    - Pharmacokinetic analyses that support the in vivo efficacy and toxicity studies
    - Drug-drug interaction such as in vitro induction and inhibition studies
    - In vitro ADME studies
    In vitro hepatotoxicity assessment such as cell viability, oxidative stress etc.
    - All in vitro mechanistic studies
  • Ex vivo studies, including
    - Drug-drug interaction such as ex vivo induction and inhibition studies,
    Ex vivo hepatotoxicity assessment such as oxidative stress etc.
    - All ex vivo mechanistic studies

 

The role of GLP studies in drug discovery is confusing to many scientists. The confusion has two causes.

1. Semantic:  GLP is an acronym for « Good Laboratory Practices. » Hence, many scientists infer that GLP studies must therefore be « good » and non-GLP studies are of questionable quality. Actually, the « good » is more about good documentation than good science.

2. Regulatory Requirements:  The regulatory bodies require GLP for far fewer types of studies than many scientists think. GLP requirements are for safety studies, not other types of studies.

The consequences of this confusion are that many drug-discovery organizations end up wasting time and resources on unnecessary and premature GLP studies when their objectives would be better achieved without the burden of GLP.

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