Download Biosimilar clinical development: scientific considerations by Kerry B. Barker, Sandeep M. Menon, Ralph B. D'Agostino Sr., PDF

By Kerry B. Barker, Sandeep M. Menon, Ralph B. D'Agostino Sr., Siyan Xu, Bo Jin PhD

Biosimilars have the aptitude to alter the best way we predict approximately, determine, and deal with illnesses. they're already impacting either medical study and sufferer care, and this impression will in simple terms develop as our figuring out and applied sciences enhance. Written via a crew of skilled experts in scientific improvement, this ebook discusses quite a few power drug improvement innovations, the layout and research of pharmacokinetics (PK) stories, and the layout and research of efficacy studies.

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Extra resources for Biosimilar clinical development: scientific considerations and new methodologies

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In recent years, the advent of technologies have changed the way we interpret this conundrum of information by exploiting the advancements of the human genome, transcriptome, and proteome, which ultimately will move targets from the stage of discovery to clinical development. Clearly, those efforts lead to the development of useful new methodologies and unprecedented scale-up of data coming from different but yet interconnected disciplines. From Isolation to Integration 25 However, it is critical to use these technologies since they produce the results needed for deeply understanding, rather than merely describing, the biological systems.

By using the newly emerging omics technologies, we can have a deeper understanding of the mechanisms playing a role in the pathogenesis of a specific disease. Thus, systems biology is generating a paradigm shift in our approaches to modeling and experimental levels. Here, we discuss systems biology as a holistic approach to obtain, integrate, and analyze complex datasets from multiple experimental sources using interdisciplinary tools and review examples of modeling strategies to build cellular models on the basis of detailed multiparametric datasets.

Clearly, those efforts lead to the development of useful new methodologies and unprecedented scale-up of data coming from different but yet interconnected disciplines. From Isolation to Integration 25 However, it is critical to use these technologies since they produce the results needed for deeply understanding, rather than merely describing, the biological systems. This is where systems biology comes into playing a significant role. Systems biology can be viewed as a discipline (a metalanguage) of concepts and models for interdisciplinary usage, which is still evolving.

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