eBook: Toxicology studies – considerations for design and regulatory requirements
In order to design a toxicology study ready for pharmaceutical development, there are many factors to consider. Despite the referred guidance for the safety evaluation of various pharmaceutical products, detailed design is dependent on such factors like the background of the test article, intended clinical use, previous data and the experience of the team involved in drug discovery. In this eBook, we will explore the bioanalytical challenges in reproductive toxicity studies and outline the key translational drug development objectives in oncology.
CONTENTS INCLUDE:
- BIOANALYTICAL CHALLENGE ARTICLE: Bioanalytical assays in support of tanezumab developmental and reproductive toxicity studies: challenges and learnings
- REVIEW: Quantitative translational modeling to facilitate preclinical to clinical efficacy & toxicity translation in oncology
- INTERVIEW: 60 seconds with Charlene Chen: toxicology studies
- INFOGRAPHIC: Toxicology studies: design considerations, dosing and instrumentation
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