Review Article
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 »
An overview of the current status of follow-on biologicals in Iran
Author(s): Farhang Rezaei, PharmD, Nassim Anjidani, PharmD
Page: 100-6
Author byline as per print journal: Farhang Rezaei, PharmD; Nassim Anjidani, PharmD Background: The advent of follow-on biologicals in Iran and biosimilars worldwide have provided various treatment options for several severe… Read More »
The EU regulatory network and emerging trends – a review of quality, safety and clinical development programmes
Page: 83-99
Author byline as per print journal: Marta Zuccarelli1, PharmD; Benjamin Micallef1, PharmD; Mark Cilia1, PharmD; Anthony Serracino-Inglott1,2, PharmD; John-Joseph Borg1,3, PhD Introduction/Study Objectives: The development of biosimilars is challenging due… Read More »
Continuous manufacturing versus batch manufacturing: benefits, opportunities and challenges for manufacturers and regulators
Page: 44-56
Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Teh Kee Siang, BSc (Pharm)(Hon); Associate Professor Chan Lai Wah, BSc (Pharm)(Hon), PhD Continuous manufacturing… Read More »
Pharmaceutical Data Integrity: issues, challenges and proposed solutions for manufacturers and inspectors
Author(s): Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc, Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD, Vernon Tay, BSc (Pharm) (Hons), Vimal Sachdeva, MSc
Page: 171-82
Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock1, BSc (Pharm), MSc; Vernon Tay1, BSc (Pharm) (Hons); Vimal Sachdeva2, MSc; Associate Professor Chan Lai Wah1, BSc (Pharm)… Read More »
Current trends for biosimilars in the Latin American market
Page: 64-74
Author byline as per print journal: Esteban Ortiz-Prado1,2, MD, MSc, MPH, PhD; Jorge Ponce-Zea3, MSc; Jorge E Vasconez1, MD; Diana Castillo,1, MD; Diana C Checa-Jaramillo1, MD; Nathalia Rodríguez-Burneo1, MD; Felipe… Read More »
Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals
Author(s): Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc, Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD, Sia Ming Kian, BSc (Pharm) (Hons)
Page: 52-63
Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Associate Professor Sia Ming Kian, BSc (Pharm) (Hons); Chan Lai Wah, BSc (Pharm) (Hons), PhD… Read More »
An ever-evolving landscape: an update on the rapidly changing regulation and reimbursement of biosimilars in Canada
Author(s): Anne Tomalin, BA, BSc, Eric CK Siu, MSc, PhD, George Wyatt, BSc, MBA, Kevin West, BA, Sandra Anderson, BA, MBA
Page: 107-18
Author byline as per print journal: Eric CK Siu1,4, MSc, PhD; Anne Tomalin2,4, BA, BSc; Kevin West3,4, BA; Sandra Anderson4, BA, MBA; George Wyatt1,4, BSc, MBA Abstract: Since the introduction… Read More »