Product Rescue- Problem Solving

Product rescue - when a toxic response is observed in a marketed product or a compound in drug development

CXR can help when client's have a problem with reported toxicity of a compound or chemical either in development or in a marketed product. We provide a problem solving service that can rescue these products by understanding the mechanisms of the observed toxicity and determining whether it is relevant to man.

Observed problem with a marketed Consumer Product

Problems with toxicity can arise at any time in the lifetime of a commodity or industrial chemical; even if a chemical has been fully evaluated prior to marketing, regulations may change or unexpected problems may arise. Often the solution is to conduct quantitative risk assessment in order to define acceptable exposures for both the public and those who may undergo occupational exposure.

Many existing chemicals were tested years ago using methods which are now considered to be outdated or inappropriate. In addition, new compounds are entering the market (and the environment) at an ever-increasing rate.

CXR Biosciences can undertake safety evaluation using the latest fully validated toxicological protocols, as well as innovative molecular approaches, in order to support regulatory submissions and provide a valid rationale for risk assessment.

Reported problem in clinical development

Compounds that have successfully progressed to clinical development have normally undergone a succession of different screens that demonstrate safety and efficacy. However, unexpected toxicological problems often arise in the clinical phase and result in trials being abandoned.

CXR Biosciences can help predict undesirable drug effects such as adverse drug reactions or inter-patient variability in response, and so reduce late stage product attrition. However, even the most thorough preclinical toxicological evaluation can only give an indication of the potential organ-specific toxicity of drug candidates in humans. When unexpected toxicity is observed in the clinic it is essential to be able to respond rapidly in order to prevent further problems.

With a wealth of experience in all aspects of drug safety, CXR can respond immediately to reported problems, devising fast turnaround studies to understand and prevent organ-specific toxicities. Through a detailed understanding of the mechanisms involved, we can help clients to decide whether and how to proceed with trials in a manner which ensures minimal risk of adverse effects.