GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 11 / Year 2022 / Issue 1
Review Article
Long-acting insulin analogues. Drug selection by means of the System of Objectified Judgement Analysis (SOJA)
Page: 25-33Author byline as per print journal: Robert Janknegt, PharmD, PhD; Marloes Dankers, MSc Study objectives: The increasing number of long-acting insulin analogues makes it difficult for general practitioners to have sufficient knowledge of each individual insulin formulation and device. Reducing the number of different insulin analogues used, based on rational criteria, allows physicians and pharmacists […]
Challenges in the manufacture, storage, distribution and regulation of traditional and novel vaccines
Page: 13-24Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock1, BSc (Pharm), MSc; Adelia Pheh1, BSc (Pharm) (Hon); Vimal Sachdeva2, MSc; Associate Professor Chan Lai Wah1, BSc (Pharm) (Hon), PhD Abstract: Since the onset of the COVID-19 pandemic, there has been a significant surge in interest of COVID-19 vaccines in particular, and other […]
Biotherapeutic products in the European Pharmacopoeia: have all challenges been tackled?
Page: 7-12Author byline as per print journal: Mihaela Buda, PhD; Olga Kolaj-Robin, PhD; Emmanuelle Charton, PhD Abstract: The approach to the elaboration of European Pharmacopoeia (Ph. Eur.) monographs in the field of biotherapeutics has significantly evolved in recent years. In particular, monographs on complex biotherapeutics call for greater flexibility as a means of better addressing the structural […]