Reproductive Toxicology Including Nonclinical Support for Paediatrics
Unlike most aspects of nonclinical toxicology, the results from reproductive toxicology studies are rarely superseded by human data. Therefore, the outcome of these specialist in vivo studies will be in product labels for many years after marketing. From the outset, it is vital that the right reproductive toxicology studies are proposed, designed and well executed followed by expert led interpretation and translation of outcome into regulatory documents and product labels.
Assisting in all aspects of reproductive toxicology
The experienced team at ApconiX can assist in all aspects of reproductive toxicology from study design through study placement/monitoring to product labelling.
This includes:
- advising clients on the most appropriate species and package of work for the intended patient group
- actively helping with health authority negotiations regarding the content and timing of reproductive toxicology packages
- supporting clinical trial applications.
Successfully helping clients with non standard contexts requiring bespoke packages of data including:
- genetically modified in vivo studies
- surrogate molecules
- approaches reliant only on weight of evidence.
Supporting clients in the:
- design of appropriate birth control for the patient population
- preparation of informed consent forms
- discussions with clinical teams regarding the impact of reproductive toxicology on the intended clinical development.
Nonclinical Support for Paediatrics
In many major territories, it is mandatory to bring forward a paediatric plan before a new drug can be approved for its adult indication.
We can assist clients in designing their paediatric development plan and provide expert help on what type, if any, nonclinical work is required to support the intended plan. The paediatric plan may require juvenile in vivo studies and ApconiX can assist in the design, placement, monitoring and interpretation of these studies.
Our scientists can also:
- co author the specialist nonclinical sections of Paediatric Investigation Plans (PIPs) for clients
- assist with responses to health authority queries
- support paediatric only indications including diseases of early infancy.
With early engagement, it is often possible to adapt other parts of the nonclinical safety package to avoid the need for stand alone juvenile in vivo studies. This saves time and cost.
We encourages clients to discuss their likely paediatric development strategy alongside their repeat dose toxicology studies and reproductive toxicology package to facilitate the design of focused, timely packages of work.
Our Reproductive Toxicologist
Dr Jane Stewart
PhD, ERT, BVM&S, MRCVS
Jane is a senior toxicologist with world leading expertise in reproductive toxicology and the safety assessment of pharmaceuticals. Jane is renowned for her expertise in problem solving for general and reproductive toxicology as well as in the investigation of endocrine effects and carcinogenesis. Jane has authored numerous pregnancy labels and has helped draft international testing guidelines for pharmaceuticals. Jane is a PhD qualified veterinarian with a degree in pathological sciences. Jane is known for her analytical mindset and ability to identify and resolve key issues.