Toxicology knowledge Team Sweden AB

Drug Project Support

Introduction:

Toxicological evaluation of drug candidates are subjected to regulatory guidelines to ensure human safety in clinical trials. To optimise project sucess, it is important to involve toxicological expertise early on. Expert planning of the toxicology program and each part of the program, gives the project freedom to operate within the rgulatory framework, and a greater chance of proceeding into clinical trials and beyond. 

With detailed planning of the toxicology studies by using the right species, setting the right doses and, above all, with proper risk assessment of findings in each phase of the development, the project saves time and resources. In the right context and assessed by the right expertise, a toxicological finding is usually not a stopper for the project to proceed into the next phase of development.

“We thought the adverse effects would be a stopper for the project, but with the help of TKT’s assessment and paticipation in a scientific advise meeting, the project could progress into the next phase”

We know from our long experience in drug development, that by involving TKT expertise early on, many issues can be resolved proactively during the process, without causing delay or increased costs.

With an experienced toxicologist involved throughout the drug development process, there is a higher chance for acceptance of the toxicological safety assessment in INDs, IMPDs, IBs NDAs and scientific advice.

Our many years of hands-on experience as study directors show that early toxicology studies (those run before Phase 1) almost never end up according to a predetermined template. Bespoke adaptation to specific circumstances of a project is always needed. TKT can help with project-specific adaptaion of studies, to ensure best possible value from each study performed.

“It was a relief to have acess to TKT’s experience since this was the first time up to and beyond Phase 1 for our company”

Depending on the needs, TKT can provide critical and timely support on a small scale. Or, if required, take on a larger responsibility in any project, or problem-solving activity. A customer oriented approach within the regulatory framework is one of the fundamentals of TKT’s motto “Optimizing toxicology”.

Common queries to TKT

Q&A | Why do I need dedicated toxicological expertise in my drug project? Isn't everything explained in the guidelines?

Client: “In retroperspective, I wish we had contcacted TKT much earlier”

Toxicological expertise is vital in all parts of drug development, but the engagement varies, depending on developmental stage, project type, indication, adverse findings etc. Therefore, we advise you to discuss your project with us, to help you set up a reasonable and realistic plan for your project’s specific needs.

Q&A | My tox batch has a number of chemical impurities. Do I need to purify it?

For small molecule pharmaceuticals, and naturally within limits, it is better to have all probable impurities present in the toxicology studies. The reason is that all impurities present in the clinical batches must have been adequately “qualified”/safety assessed in early pivotal tox studies. Otherwise, additional studies might be requested from authorities, which may cause substantial interruption in the development.

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Client: “I incorrectly assumed that toxicology the study program prior to Phase 1 was more or lessgeneric”