Non-GLP Toxicology & Screening – Preclinical Development Services
Fast, flexible non-GLP studies to de-risk your lead compound before committing to GLP testing
Why Non-GLP Screening Studies Matter
研究設計プロセスを円滑に導き、前臨床研究の加速を支援いたします
Before committing to a full GLP toxicology program, most sponsors need faster, more flexible studies to confirm dose range, tolerability, and translational relevance. Non-GLP screening studies let you make informed go/no-go decisions early, without the cost and lead time of a GLP-compliant program.
Our team designs non-GLP studies tailored to your molecule and development stage, applying the same scientific rigor that carries through into GLP testing when your program is ready for it.
When you’re ready to move forward, our GLP Safety Assessment team can take the same lead compound through IND-enabling testing.
私たちのアプローチ
Tailored Study Design From Discovery Through Screening
Our team applies a tailored approach to the pharmacology and toxicology aspects of your research, adjusting study design on a case-by-case basis. With a broad portfolio of methods and models, we help determine the transferability and reliability of your results, supporting the transition of your compounds from bench to clinic.
Our team can also support your clinical hypothesis using a pharmacometrics approach. Using tools such as population-based pharmacokinetic modeling (PopPK), we help you optimize your clinical setup for specific patient substrata.
治療薬開発を推進するため、専門家と提携しましょう。
当社のチームと協力し、精密かつ専門的な知見をもって、貴社の薬剤と治療標的の効果を評価します
当社の能力
Non-GLP Pharmacology and Toxicology Capabilities
Our team is equipped to provide non-GLP preclinical studies in rodents, along with safety pharmacology studies across various in vitro model systems. An established third-party partner extends this support to non-rodent species when needed.
Our in vitro toxicology portfolio continues to expand, including new approach methodologies (NAMs) such as genetic toxicity, mutagenicity, carcinogenicity, liver toxicity, cardiotoxicity, and neurotoxicity screening.
生体内薬理学
- 薬物動態学的特性
- 治療効果研究
- 薬物動態学
- 最大耐容量（MTD）の決定
- Dose-response relations
- トランスレーショナル疾患モデル
Non-GLP Toxicology
- Non-GLP single-dose toxicity (acute tolerability screening)
- Non-GLP repeated-dose toxicity (dose range-finding)
- 毒性動態学
- Medical device biocompatibility screening
Ready for GLP-Compliant Studies?
Once your program is ready to move into IND-enabling testing, our team supports the transition into GLP-compliant toxicology, safety pharmacology, and immunotoxicology studies.
医薬品開発パイプラインのナビゲーション
AAALAC認定
InnoSerはAAALAC認証を取得し、責任ある動物ケアと利用への取り組みを実証しています。AAALAC Internationalは、自主的な認証および評価プログラムを通じて科学における動物の適切な扱いを推進する非営利組織です。InnoSerのオランダおよびベルギー施設は、それぞれ2016年および2020年よりAAALAC認証を取得しています。AAALAC認証プログラムの詳細はこちらをご覧ください。
動物福祉
3R原則は、政策や規制の変更から新技術・手法の開発と普及に至るまで、あらゆる分野に影響を及ぼします。このためInnoSerは、これらのプロセスに対する継続的な取り組みと監視を実施しています。当社が実践する手順は、動物実験の代替・削減・改善を最大限に実現し、研究および医薬品開発におけるこれらの原則への取り組みを促進します。
info@innoserlaboratories.com