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Toxicology Specialists 2017-10-06T13:55:25+00:00

Toxicology Specialists

Toxicology is a complex, multidisciplinary science that requires integration of diverse skill sets and creative thinking. Whatever your project issues, wherever you are on the drug discovery and development journey, our team approach gives you access to all the expertise you need to achieve your next milestone.  Our world-leading expertise will guide you towards scientific and regulatory success.

Whatever the challenge you face, ApconiX has world renowned scientists in several key technical disciplines able to work with you on a flexible or on-going basis.  We also have an extensive global network of experts that allows us to find the most effective solution to any problem.  We will provide you with the best advice at the right time to make the best decisions for your project.

Our specialist areas include:

  • Reproductive, development and juvenile toxicity
  • Paediatric plans
  • Genetic toxicology
  • Safety pharmacology
  • Drug metabolism and pharmacokinetics
  • Immunotoxicology and immuno-oncology
  • Study monitoring, CRO selection and study design
  • Calculation of permissible daily exposure (PDE) and occupational exposure limit (OEL)
  • Delivery of integrated, bespoke training packages

Reproductive & Paediatric Toxicology

We can make sure you have the appropriate preclinical package to support progression of your asset into children and women. We will:

  • Advise on content, timing and preparation of nonclinical aspects of your Paediatric Investigation Plan (PIP)
  • Design, monitor and interpret reproductive, juvenile and developmental toxicology studies
  • Representation at regulatory agency interactions

General Toxicology

We take a scientific approach to make sure you have the appropriately designed, fit-for-purpose preclinical package to support your clinical objectives.  We will:

  • Design, monitor and interpret general toxicology studies to meet global registration standards
  • Advise on appropriate CRO selection and conduct audits as needed
  • Review study plans and reports to ensure GLP and regulatory acceptance

Genetic Toxicology

Mishandling of genetic toxicity issues can change the fundamental course of a project. Our experts understand the importance of getting the right data with the correct approach to progress your asset. We will:

  • Design the genetic toxicology package to fit your project needs, in compliance with the regulatory guidelines
  • Design and interpret the in vitro and in vivo genetic toxicology studies
  • Representation at regulatory agency interactions

Investigative Toxicology

Even the most challenging projects can be made successful by applying creative problem-solving and delivery of innovative solutions.

Our collective experience, broad knowledge base and extensive networks within academia and industry enables us to deliver problem-solving strategies to address safety issues.

We will critically evaluate an issue, develop hypotheses and design innovative experiments that lead to timely project decisions.

Want To Find Out More?

To discuss the best approach for your drug project, please get in touch with Ruth Roberts via phone or email ruth.roberts@apconix.com
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