We offer an optimal package service for you to achieve your goal, such as IND application and out-licensing
While GLP study items are designated by ICH guidelines, there are various methods to plan the entire preclinical development and preliminary studies. The selection of the study design makes a large difference in the overall study duration and cost.
Here at Axcelead, our safety evaluation researchers, who possess vast experience with drug discovery and reliable technology, propose the most efficient strategy for preclinical development and manage the entire study from study design and execution to interpretation of the result. Furthermore, we offer consulting services for toxicity issues and support for communication with regulatory authorities such as PMDA and FDA.
Total support for preclinical development to achieve your goal
- We conduct document-based evaluation based on existing data on pharmacology, physical characteristics, pharmacokinetics and safety of a compound, and prepare and propose a package of safety studies and services necessary for achieving your goals (IND application, out-licensing).
- In addition to management of the entire study, we offer a complete support package that includes interpretation of the safety margin and solution for toxicity issues.
- We collaborate with other divisions of pharmacology, chemistry, and ADME and our partner CROs and offer optimal solutions such as early toxicity screening by incorporating toxicity evaluation into a pharmacological study at reasonable prices.
We propose the most appropriate menu for safety studies according to the development status of the compound.
- We conduct an efficient, non-GLP in vivo study to select a promising compound for prompt IND application and facilitate preclinical safety evaluation.
- We propose a study protocol by optimizing the animal strain, administration period, and test items according to the development status of the compound such as the profile of the candidate compound for development and presence/absence of competitors. We contribute to cost reduction by eliminating unnecessary studies.
Broad range of support that includes solutions for safety and pharmacokinetic issues and addressing new modalities by experts with knowhow for more than 100 INDs and 20 NDAs/BLAs
- Our safety evaluation team, comprising toxicologists and toxicologic pathologists/veterinary pathologists, offers consultation not only regarding the preclinical phase but also toxicity issues occurring during the clinical phase.
- Regarding pharmacokinetics, our team with extensive experience on development offers support in line with your objective such as prediction of human PK/PD, risk evaluation of drug interactions and planning of development strategy for metabolites.
- We also deal with new modalities such as antibody and oligonucleotide therapeutics by leveraging our broad range of experience and the latest knowledge.
We offer comprehensive support for smooth IND application and out-licensing by using our experience with numerous applications in Japan, the EU and the US and knowledge gained through in-licensing investigation!
Integrated pre-clinical development