GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 7 / Year 2018 / Issue 3
Original Research
Implementing a treatment registry for a biosimilar: continuous safety surveillance of the biosimilar Bevax® (bevacizumab) in Argentina
Author(s): Francisco Fernández, MD, Matías Deprati, MD, Patricia Rodríguez Acedo, Eduardo Spitzer, BSc, Alvaro Romera, MD, Nadia Español, BSc
Page: 111-20Introduction and study objectives: Benefit-risk evaluations are essential throughout the life cycle of a drug to guarantee therapeutic efficacy for the authorized indications without an unacceptable incidence of adverse effects. To achieve this, a registry, assessment of adverse drug reactions (ADRs) and other pharmacovigilance (PhV) procedures are mandatory. Due to the inherent variability of bioproduction, […]
In vitro analytical and antibiotic comparison of generic moxifloxacin against E. coli and S. aureus bacteria strains
Author(s): Antistio Alviz-Amador, MSc, Jairo E Mercado Camargo, MSc, Marlene Duran-Lengua, MSc, PhD
Page: 121-6Author byline as per print journal: Auxiliary Professor Antistio Alviz-Amador1, MSc, Pharmaceutical Chemist; Jairo E Mercado Camargo2, MSc; Marlene Duran-Lengua3, MSc, PhD, Bacteriologist Introduction: Moxifloxacin is a quinolone antibiotic often used to treat infections caused by Gram-positive bacteria that have developed resistance in Colombia in recent years. Objective: To evaluate the concentration of active ingredient and the antibacterial […]
Extended stability of a biosimilar of trastuzumab (CT-P6) after reconstitution in vials, dilution in polyolefin bags and storage at various temperatures
Author(s): Muriel Paul, PharmD, Professor Alain Astier, PharmD, PhD, Victoire Vieillard, PharmD
Page: 101-10Author byline as per print journal: Victoire Vieillard, PharmD; Professor Alain Astier, PharmD, PhD; Muriel Paul, PharmD Objectives: This study assessed the long-term stability of the trastuzumab biosimilar CT-P6 (Herzuma®, Biogaran) in vials under various storage conditions; after reconstitution of the lyophilized powder (21 mg/mL) and after dilution for final concentrations of 0.8 mg/mL and 2.4 […]
