The Impact of Inadequate Temperature Storage Conditions on Aggregate and Particle Formation in Drugs Containing Tumor Necrosis Factor-Alpha Inhibitors.

Vlieland, N D; Nejadnik, M R; Gardarsdottir, H; Romeijn, S; Sediq, A S; Bouvy, M L; Egberts, A C G; van den Bemt, B J F; Jiskoot, W

Vlieland, N D; Nejadnik, M R; Gardarsdottir, H; Romeijn, S; Sediq, A S; Bouvy, M L; Egberts, A C G; van den Bemt, B J F; Jiskoot, W.

Afiliación

Vlieland ND; Department of Clinical Pharmacy, Division Laboratory and Pharmacy, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.
Nejadnik MR; Division of BioTherapeutics, Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.
Gardarsdottir H; Department of Clinical Pharmacy, Division Laboratory and Pharmacy, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands. H.Gardarsdottir@umcutrecht.nl.
Romeijn S; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands. H.Gardarsdottir@umcutrecht.nl.
Sediq AS; Division of BioTherapeutics, Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.
Bouvy ML; Division of BioTherapeutics, Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.
Egberts ACG; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
van den Bemt BJF; Department of Clinical Pharmacy, Division Laboratory and Pharmacy, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.
Jiskoot W; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

Pharm Res ; 35(2): 42, 2018 Feb 05.

Article en En | MEDLINE | ID: mdl-29404710

Asunto(s)

Antiinflamatorios/química; Factores Biológicos/química; Congelación/efectos adversos; Agregado de Proteínas; Factor de Necrosis Tumoral alfa/antagonistas & inhibidores; Adalimumab/química; Adalimumab/farmacología; Antiinflamatorios/farmacología; Factores Biológicos/farmacología; Certolizumab Pegol/química; Certolizumab Pegol/farmacología; Química Farmacéutica; Almacenaje de Medicamentos/normas; Etanercept/química; Etanercept/farmacología; Tamaño de la Partícula

Palabras clave

TNF-α inhibitors; aggregation of antibodies; drug product characterization; freezing stress conditions; home storage

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Factores Biológicos / Factor de Necrosis Tumoral alfa / Agregado de Proteínas / Congelación / Antiinflamatorios Idioma: En Revista: Pharm Res Año: 2018 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Estados Unidos

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