Expert Review of Liver Tox – Save Your Project from an Unjust Death
Signs of liver toxicity from experimental results can mean that a project is killed or investors walk away, but this is often an inappropriate response. Liver toxicity is a highly complex issue and in an attempt to provide some light on the issue the FDA has recently published guidelines on Drug Induced Liver Injury (DILI). These guidelines set the regulatory standard and take a very pragmatic position on liver tox and encourage industry to likewise take a pragmatic view.
However Companies need help in reviewing data and taking that pragmatic view, in response to this IDA consultants have made available a number of experts to provide the review that will help you:
- DON’T kill your project without good cause
- DO understand what the data actually means
- PLACE your results in therapeutic context
- REASURE investors with expert opinion
Liver Toxicity Data Review and Expert Opinion
Worrying liver tox results can come from a number of sources:
- Pre-Clinical
- Clinical
- In-Vitro
- Metabolite Studies
- Class effects
IDA consultants has arranged a group of high caliber experts, all with masses of FDA and EMEA experience who can review your data and make recommendations that put it in context of the DILI regs and the therapeutic / technology risk profile:
- PK/PD
- Standards of Care
- Co-morbidities
- Product specific factors
- Risk/Benefit ratio
Re-capture the value in your project
The outcomes of this work is an expert report that puts the Liver tox data in context, and puts the value back in your technology. The expert report is of a standard suitable for investors, and regulators alike.
This review can save your project from an un-just death, and is available from £7000. The first step is to organize a Free review so you can understand the options available for your technology without spending a penny.
