Get Biosimilar clinical development: scientific considerations PDF

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

ISBN-10: 1315373262

ISBN-13: 9781315373263

ISBN-10: 1482231697

ISBN-13: 9781482231694

ISBN-10: 1482231700

ISBN-13: 9781482231700

Biosimilars have the aptitude to alter the best way we predict approximately, determine, and deal with illnesses. they're already impacting either scientific study and sufferer care, and this influence will simply develop as our realizing and applied sciences increase. Written through a group of skilled experts in scientific improvement, this ebook discusses a number of strength drug improvement techniques, the layout and research of pharmacokinetics (PK) stories, and the layout and research of efficacy studies.

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There seems to be no consensus yet globally on what should be the type I error of α. 025. Biosimilars for Drug Development: The Time Is Now! 05 was used in FDA briefing document [19] to the advisory committee meeting for Sandoz’s proposed biosimilar to Neupogen® (later approved as Zarxio in 2015). Analysis population for the primary endpoint needs to be carefully considered as well. The intent-to-treat (ITT) population includes every subject who is randomized and does not remove patients with noncompliance, protocol deviations, withdrawal, or anything that happens after randomization from the analysis [20].

The sample size and duration of the comparative clinical study should also be adequate to allow for the detection of clinically meaningful differences between the two products in terms of safety and immunogenicity. 7 Safety and Immunogenicity Data The comparative study is also to assess the similarity in the long-term safety and immunogenicity profiles between the proposed biosimilar and the reference product. Care should be given to compare the type, severity, and frequency of the adverse reactions between the biosimilar and the reference product, particularly on those specific safety issues that have been noticed for the reference product, as well as the possible safety concerns that may result from a manufacturing process different from that of the reference product, especially those related to infusion-related reactions and immunogenicity.

Statistical considerations in biosimilar clinical efficacy trials with asymmetrical margins. Statistics in Medicine 32(3):393–405. 17. Phillips, K. F. 1990. Power of the two one-sided tests procedure in bioequivalence. Journal of Pharmacokinetics and Biopharmaceutics 18(2):137–144. 22 Biosimilar Clinical Development 18. Schuirmann, D. 1987. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of Pharmacokinetics and Biopharmaceutics 15(6):657–680.

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Biosimilar clinical development: scientific considerations and new methodologies by Kerry B. Barker, Sandeep M. Menon, Ralph B. D'Agostino Sr., Siyan Xu, Bo Jin PhD

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