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Lead Preclinical Development for students,scholars,researchers...
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Once the most promising hit compounds have been identified as leads through the efforts of hit to lead, it will enter the stage of lead optimization and preclinical development of early drug development, which are the key processes for finalizing drug candidates entering clinical trials. Lead optimization aims to improve the properties of lead compounds including stability, potency, efficacy, exposure, safety, etc. Lead optimization involves a sophisticated iterative stage in which the bioactivity and drug activity of the lead series are extensively optimized through various screening filters, and development candidates are ultimately determined for preclinical development. Preclinical development, also known as IND-enabling studies, involves testing development candidates in various in vitro and in vivo assays to examine their safety pharmacology and toxicology profile.
With established in vitro/in vivo approaches and our advanced zebrafish screening platform, Creative Biostructure can start from the identified potential lead compounds to study stability, bioavailability, toxicity, efficacy, and other pharmacokinetic parameters to improve their target specificity and potency. Our lead optimization and preclinical development solutions can provide you with better quality leads that have a high probability of success in clinical development.
Drug development is a high-risk investment, especially when entering the clinical development stage, developers are faced with high costs and increasing attrition rates. Therefore, early determination of the absorption, distribution, metabolism, excretion (ADME), and toxicological (Tox) properties of the lead series is an effective strategy to balance the risk-reward ratio and improve project productivity. Creative Biostructure agrees with this view of “fail early and fail cheap”, and we provide in vitro ADME-Tox profiling solutions for global customers with drug development needs to evaluate the ADME-Tox properties of drug candidates and prioritize them. We have a well-trained and knowledgeable drug discovery team, and we have gained extensive in vitro ADME-Tox expertise and experience through cooperation with academic institutions, biotech, and pharmaceutical companies.
We can provide a wide range of in vitro ADME-Tox services, including physicochemical profiling, in vitro ADME and PK, and toxicological assessments. We offer flexible approaches for ADME-Tox profiling, with many tests available in multiple formats, allowing you to select different throughput and service portfolio based on project requirements. Advanced equipment allows high-throughput in vitro screening, which is time-saving and cost-effective. Moreover, we can combine the experimental results to optimize the lead structure.
Reference • Everett J R. NMR-based pharmacometabonomics: A new paradigm for personalised or precision medicine. Progress in Nuclear Magnetic Resonance Spectroscopy. 2017, 102: 1-14.
Excerpt from: https://drug-discovery.creative-biostructure.com/lead-optimization-and-preclinical-development-p28