http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
design and analysis of follow-on biologics
"Biologic drug products are therapeutic moieties that are manufactured using a living system or organism. These are important life-saving drug products for patients with unmet medical needs. They also comprise a growing segment in the pharmaceutical industry. In 2007, for instance, worldwide sales of biological products reached $94 billion US dollars, accounting for about 15% of the pharmaceutical industry's gross revenue. Meanwhile, many biological products face losing their patents in the next decade."--
Introduction -- Bioequivalence experience for small-molecule drug products -- Regulatory requirements for assessing follow-on biologics -- Criteria for similarity -- Statistical methods for assessing average biosimilarity -- General approach for assessing biosimilarity -- Non-inferiority versus equivalence/similarity -- Statistical test for biosimilarity in variability -- Sample size for comparing variabilities -- Impact of variability on biosimilarity limits for assessing follow-on biologics -- Drug interchangeability -- Issues on immunogenicity studies -- CMC requirements for biological products -- Test for comparability in manufacturing process -- Stability analysis of biosimilar products -- Assessing biosimilarity using biomarker data -- Current issues in biosimilar studies.
Description based on opening page (viewed Mar 21, 2018).