The Role of Investigative Toxicology and Safety Biomarkers in Drug Safety Evaluations

  • By: Admin
  • Date: December 09, 2009

Toxicology, Pharmacovigilance, Drug Safety Evaluation - Explained

Toxicology is the study of adverse effects of chemicals on living organisms. It is the study of symptoms, treatments and detection of poisoning. The relationship between the dosage and its effect on the exposed organism is of high importance in toxicology. Investigative toxicology focus on making drugs safe for human use. It involves a series of clinical tests on lab specimens (mostly rats) to access the risk of any toxic reactions before human trials. Drug safety evaluation or more so known as Pharmacovigilance is the science relating to the detection, assessment, understanding and prevention of adverse effects of medications, biological products, herbalism and traditional medicines, particularly long term and short term side effects. The aim is to collect new information on hazards of medicines and to prevent harm to patients.

Pharmacovigilance is gaining importance with both Doctors and Researchers in Pharma due to the media attention and reports of recalls, any adverse effects due to medication. Though medicines have improved treatment and control of various diseases over the years, they are also known to cause adverse reaction in humans. This stems from the fact that though medicines target the symptoms and mechanisms of a particular disease, they are known to affect other organs or react negetively with the internal system when taken with other medicines.

Drug safety evaluation aims to increase the predictivity of such adverse reactions so as to reduce the risk. Toxicology evaluations encompass several key areas of evaluation including: safety pharmacology, genetic toxicology, target organ toxicity assessments, functional toxicity assessments (non-target organ related), developmental and reproductive toxicology, but what happens when a toxicity issue arises and there isn't a clear cut path forward for drug development?  This is when mechanistic or investigative toxicology evaluations may be necessary in order to better define risk.  In addition, the field of safety biomarkers is rapidly emerging and the regulatory agencies are encouraging their development as well as submission of safety biomarker data.

In the US, it is the function of the Food and Drug Administration (FDA) to establish these regulatory requirements. The European Medicines Agency (EMEA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) are also important regulatory authorities in drug development. These three agencies oversee the three largest markets for drug sales.

Reference Regulatory Link URL:

Nonclinical Drug safety assessment encompass several regulatory mandated areas of evaluation and the study designs and data reporting criteria  for these regulatory submissions are fairly well defined,  but what happens when a toxicity issue arises and the development decisions are not clear cut? What additional data sets might be needed and how do these mechanistic or investigative data sets get integrated into the regulatory filings and how will they be evaluated by  the regulatory agencies?
What about safety biomarkers? Should companies jump on this band wagon and what is the current regulatory path-forward for safety biomarker development?

ComplainceOnline has scheduled a training to answer all the above questions.

This training will look at several toxicity issues that must be addressed in the drug safety assessment, define the current best practices for evaluation of these issues, highlighting the key data sets that regulatory agencies want to see in order to evaluate the overall safety of the drug candidate. An update on the current state of safety biomarker regulatory path will be discussed. Case studies will be used to highlight the path forward evaluations for key toxicity issues that often arise during routine drug safety assessment studies. Participants will obtain an overall understanding of the principles of non-clinical safety evaluation with emphasis on application and interpretation of non-clinical safety data as it relates to and is integrated into the multi-disciplinary development plans and how it affects decision-making at each stage of the development process. This training will highlight key toxicity issues that should be followed up through mechanistic/investigative studies, define the current best practices in these key areas and define what the regulatory agencies want to see in terms of mechanistic/investigative follow-up and safety biomarker and the defined regulatory path in terms of data submissions.

Click the below link to view details and register for this training.
Nonclinical Drug Safety Evaluations in Drug Development
January 21, Thursday 10:00 AM PST | 01:00 PM EST

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