Subvisible Particle Content, Formulation, and Dose of an Erythropoietin Peptide Mimetic Product Are Associated with Severe Adverse Postmarketing Events

Journal of Pharmaceutical Sciences

Volumn 105, Issue 3, 2016, Pages 1023-1027

  Kotarek, Joseph ^a   Stuart, Christine ^a   De Paoli, Silvia H ^a   Simak, Jan ^a   Lin, Tsai Lien ^a   Gao, Yamei ^a   Ovanesov, Mikhail ^a   Liang, Yideng ^a   Scott, Dorothy ^a   Brown, Janice ^a   Bai, Yun ^b   Metcalfe, Dean D ^b   Marszal, Ewa ^a   Ragheb, Jack A ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

Author keywords

formulation; particle sizing; peptides; protein aggregation

Indexed keywords

PEGINESATIDE; ERYTHROPOIETIN; NANOPARTICLE; PARTICULATE MATTER; PEPTIDE;

ADVERSE OUTCOME; ARTICLE; BIOLOGICAL ACTIVITY; CELL ACTIVATION; CONCENTRATION (PARAMETERS); DRUG FORMULATION; DRUG RECALL; DRUG SURVEILLANCE PROGRAM; EXPERIMENTAL STUDY; HUMAN; HUMAN CELL; IMAGING; MAST CELL; NANOANALYSIS; ADMINISTRATION AND DOSAGE; ADVERSE EFFECTS; CELL CULTURE; DRUG HYPERSENSITIVITY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; MEDICINAL CHEMISTRY; PARTICULATE MATTER; PHASE 3 CLINICAL TRIAL (TOPIC); POSTMARKETING SURVEILLANCE; PROCEDURES;

CELLS, CULTURED; CHEMISTRY, PHARMACEUTICAL; CLINICAL TRIALS, PHASE III AS TOPIC; DRUG HYPERSENSITIVITY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; ERYTHROPOIETIN; HUMANS; NANOPARTICLES; PARTICULATE MATTER; PEPTIDES; PRODUCT SURVEILLANCE, POSTMARKETING;

EID: 84964490348     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1016/S0022-3549(15)00180-X     Document Type: Article

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