Výsledky vyhledávání - issues array analysis - methods

A Polymer Cochlear Electrode Array: Atraumatic Deep Insertion, Tripolar Stimulation, and Long-Term Reliability Autor Gwon, Tae Mok

Handbook of research methods in behavioural economics : an interdisciplinary approach /

Discourse, Peace, and Conflict Discursive Psychology Perspectives /

Taming the Corpus From Inflection and Lexis to Interpretation /

Dynamic Oracle Performance Analytics Using Normalized Metrics to Improve Database Speed / Autor Cornejo, Roger

Biosimilars Regulatory, Clinical, and Biopharmaceutical Development /

Obsah: “…Section I: Biosimilars, Regulatory landscape, health economics and Intellectual Property landscape -- Biosimilars 101 - An Introduction to Biosimilars -- Innovation, Patents and Biologics: The Road to Biosimilar Competition -- Factors influencing investment, business decisions and marketing of biosimilars -- The Changing US Reimbursement Landscape and Biosimilars -- Litigation-Related Issues Under The Biologics Price Competition and Innovation Act -- Section II: Target Product Profile, QbD, CMC, Biosimilar manufacture platform technologies -- Design and implementation of successful regulatory strategies in biosimilar development -- Health Canada's perspective on the clinical development of biosimilars and related scientific and regulatory challenges -- EU Perspective on Biosimilars -- Section III: Pharmaceutical development of Biosimilars; analytical comparability; higher order structure -- QbD in biopharmaceutical manufacturing and biosimilar development -- Drug Product Development and Manufacturing considerations for biosimilars -- Section IV: Biosimilars- clinical and non-clinical development; immunogenicity; Extrapolation and Interchangeability -- Principles of Analytical Biosimilarity Assessment -- Application of an Adaptive Analytical Characterization Strategy to Support Development and Approval of Biosimilars -- Higher Order Structure methods for similarity assessment -- Protein Conformational Array for Biologics Higher Order Structure Similarity Analysis -- Protein particulates and biosimilar development: analytical tools and therapeutic implications -- Biological activity assays for antibody therapeutics -- Statistical Considerations for Demonstration of Analytical Similarity -- Section V: Biosimilars- Global development and clinical experience -- Comparative clinical studies for biosimilar development -- Immunogenicity assessment of biosimilars: A multidisciplinary perspective -- Interchangeability of biosimilar therapeutics -- Extrapolation of Biosimilars -- Totality of evidence and the role of clinical studies in establishing biosimilarity -- Section VI: Biosimilars- Global Development and Clinical Experience -- Pharmacovigilance of Biosimilars - Global experience and perspective -- Development and Commercialization of Biosimilars in India - Current Regulatory and Clinical Experience.…”

Exergy for A Better Environment and Improved Sustainability 2 Applications /

Vibration Control of Active Structures An Introduction / Autor Preumont, André