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A Frequently Asked Question in Non-Clinical Development: Is there a Need for (Bio)Analytical Method Validation under GLP Conditions?
Regulatory, Method Validation
By Roman Goetz
Bioanalytical methods (as well as dose formulation assays) used in GLP-compliant nonclinical studies (as well as dose formulation assays) should be validated. Regulatory requirements on GLP-compliance of method validation are different in the ICH geographies. Here, we are discussing the requirements and their implications on method validation.
Establishing a Safe and Efficacious Human Starting Dose: A Hurdle for Cell and Gene Therapies
Human Starting Dose, Cell and Gene Therapy Products
By Anika Schroeter and Marko Repic
Definition of a human starting dose is a challenging step in every development process, representing a particular hurdle for gene and cell therapy products. In contrast to small molecules or biologics, there is no specific guidance, providing clear recommendations on how to determine a human starting dose. Individual, product-tailored and innovative approaches are needed, which require a thorough understanding of the indication, mode of action and potential risks related to the product. Read further to learn more about specific approaches and our experience with different cell and gene therapy products.
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