Review Article
Statistical tests for detecting reference product change in biosimilar studies
Page: 50-60
Author byline as per print journal: Jiayin Zheng1, PhD; Peijin Wang`2, MS; Yixin Wang3, PhD; Shein-Chung Chow2, PhD For the biosimilarity assessment between a test product and a reference product,… Read More »
Development of Ph. Eur. standards for therapeutic monoclonal antibodies: infliximab case study
reference preparations Abstract: This article describes the European Pharmacopoeia exploratory study on infliximab as a test case for developing public standards for monoclonal antibodies. The design and outcome of the… Read More »
Manufacture and regulation of cell, tissue and gene therapy products: global perspectives, challenges and next steps
Page: 65-81
Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Christine Koh, BSc (Pharm) (Hon); Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD Cell, tissue… Read More »
Long-acting insulin analogues. Drug selection by means of the System of Objectified Judgement Analysis (SOJA)
Page: 25-34
Author byline as per print journal: Robert Janknegt, PharmD, PhD; Marloes Dankers, MSc Objectives: The increasing number of long-acting insulin analogues makes it difficult for general practitioners to have sufficient… Read More »
Challenges in the manufacture, storage, distribution and regulation of traditional and novel vaccines
Page: 13-24
Author 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)… Read More »
Biotherapeutic products in the European Pharmacopoeia: have all challenges been tackled?
Page: 7-12
Author 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… Read More »
Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador
Page: 184-92
Author byline as per print journal: Esteban Ortiz-Prado1, MD, MSc, MPH, PhD(c); Enrique Teran2, MD, PhD; Raul Patricio Fernandez Naranjo1, MSc; Doménica Cevallos-Robalino1, MD; Eduardo Vasconez1, MD; Alex Lister3, MPH At… Read More »
The European framework for intellectual property rights for biological medicines
Page: 172-83
Author byline as per print journal: Josette Sciberras, MBA, MA Bioethics, BPharm (Hons); Raymond Zammit, SThD; Patricia Vella Bonanno, PhD Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to… Read More »
Microbiological, scientific and regulatory perspectives of hand sanitizers
Page: 130-40
Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Tan Ying Ting, BSc Pharm (Hons); Associate Professor Chan Lai Wah, BSc Pharm (Hons), PhD… Read More »
A critical review of substitution policy for biosimilars in Canada
Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP
Page: 123-9
Author byline as per print journal: Professor Philip J Schneider1, MS, FASHP, FASPEN, FFIP; Michael S Reilly2, Esq Canada has approved a total of 36 biosimilars. While the approval of… Read More »