… PEGylation approaches, and concepts and issues in drug … for the development of improved
biopharmaceutical drugs … that doses of PEGylated proteins for nonclinical toxicity study are …

… information for approved PEGylated biopharmaceuticals indicated that their … collective
experience gathered from multiple nonclinical toxicology studies of PEGylated biopharmaceuticals …

… PEGylated biopharmaceuticals have been approved in Europe and the United States, across
multiple indications. PEGylated … non‐clinical toxicology studies for about half the PEGylated …

… are developed in preclinical studies [Citation17]. Further studies have focused on the
antitumoral activity of PEGylated … similar biological and biopharmaceutical behavior [Citation62]. …

… The preclinical toxicity data for PEG in PEGylated biologics … of the medicine, not the PEG
moiety, according to experience with commercially available PEGylated pharmaceuticals. …

… Biopharmaceuticals have developed rapidly in recent years due … Since the basic structure
of biopharmaceuticals can be designed … The PEGylation of the Fab domain is also expected to …

… for a market-approved PEGylated biopharmaceutical: … based on the experience gained during
development or manufacture. A … We have described our reasons for this action below and, …

… associated to the PKU diet are other important reasons to seek alternative therapies (41). …
immunogenicity incidence in nonclinical species post-PEGylation (confidential discussions). …

… This review will address the primary reasons for PEGylation as applied to marketed proteins…
biopharmaceuticals with many more in development, including biosimilars of PEGylated …

… Therefore, the formulation used in the preclinical and clinical development phases may …
were developed later are PEGylated interferon alfa-2a and -2b (see Fig. 22.3c), PEGylated hG-…