Review Article
Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries
Page: 40-54
Author byline as per print journal: Pritha Paul1, PhD; Rahul Kapur2*, MBBS, PhD; Shivani Mittra3, MPharm, PhD; Nimish Shah4, JD, MBA; Gopal K Rao1, MSc; Matthew E Erick4, BS, RPh;… Read More »
The incorporation of the Halal Management System (HMS) by the pharmaceutical industry
Page: 87-94
Author byline as per print journal: Ka-Liong Tan1, DPhil; Ainoon Othman1; Irwan Mohd Subri2,3; Noor Fadzilah Zulkifli1; Mohd Mahyeddin Mohd Salleh3; Nazariyah Yahaya4; Khairun Nain Nor Aripin1; Shahirah Nadiah Shaharuddin5;… Read More »
Trends in Saudi FDA drug approvals and GMP inspections: an observational study
Page: 76-86
Author byline as per print journal: Ali M Alhomaidan, PhD; Mohammed Abdulaziz Alageel, MSc; Turki Abdulaziz Alrafie, MSc; Hassan Mohammed Alqarni, MSc; Ibraheem Yahya Khbrani, MSc; Dalal J Alkhamis, MSc;… Read More »
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 Abstract: For the biosimilarity assessment between a test product and a reference… Read More »
Development of Ph. Eur. standards for therapeutic monoclonal antibodies: infliximab case study
Abstract: This article describes the European Pharmacopoeia (Ph. Eur.) 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: 65-80
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 Abstract: Cell,… Read More »
Long-acting insulin analogues. Drug selection by means of the System of Objectified Judgement Analysis (SOJA)
Page: 25-33
Author 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… 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 »