Review Article
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 »
Are there biosimilar orphan drugs for Gaucher disease? An overview in Mexico
Author(s): A Esquivel-Aguilar, PhD, CM Hernández-Guadarrama, MD, E Terreros-Muñoz, MD, G Castañeda-Hernández, JE García Ortiz, PhD, JI Navarrete-Martínez, MD, L Carbajal-Rodríguez, MD, M Cerón-Rodríguez, MD, Professor LC Correa-González, MD, SJ Franco-Ornelas, MD, Y Santillán-Hernández
Page: 71-5
Author byline as per print journal: G Castañeda-Hernández, PhD; L Carbajal-Rodríguez, MD; M Cerón-Rodríguez, MD; Professor LC Correa-González, MD; A Esquivel-Aguilar, PhD; SJ Franco-Ornelas, MD; JE García Ortiz, PhD; CM… Read More »
The need for distinct nomenclature for originator and biosimilar products
Author(s): 1 Michael Sarshad, BSc, MBA, 2 Rosanne Campbell, BComm, PGdip, MSc, 3 Peter J Pitts, BA, Jacqueline Vanderpuye-Orgle, MSc, PhD
Page: 152-7
Author byline as per print journal: Michael Sarshad, BSc, MBA; Rosanne Campbell, BComm, PGdip, MSc; Peter J Pitts, BA; Jacqueline anderpuye- Orgle, MSc, PhD Abstract: As the number of biosimilar… Read More »
Protein heterogeneity and the immunogenicity of biotherapeutics
Author(s): Professor Roy Jefferis, PhD, DSc, MRCP, FRCPath
Page: 63-9
Abstract: High resolution analytical techniques reveal structural micro-heterogeneity within endogenous proteins, however, they are ‘seen’ as ‘self’ molecules by the immune system and immunological tolerance is established. In contrast the… Read More »
The impact of religion on human embryonic stem cell regulations: comparison between the UK, Germany and the US
Author(s): Ali M Alhomaidan, PhD, Hajaj M Alhomaidan
Page: 22-5
Author byline as per print journal: Hajaj M Alhomaidan; Ali M Alhomaidan, PhD Abstract: This paper describes the differences in human embryonic stem cell regulations in several Christian countries across… Read More »