Review Article

Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador

Published in: Volume 10 / Year 2021 / Issue 4
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

Published in: Volume 10 / Year 2021 / Issue 4
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

Published in: Volume 10 / Year 2021 / Issue 3
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

Published in: Volume 10 / Year 2021 / Issue 3
Author(s): ,
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

Published in: Volume 10 / Year 2021 / Issue 2
Author(s): ,
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

Published in: Volume 10 / Year 2021 / Issue 2
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

Published in: Volume 10 / Year 2021 / Issue 1
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

Published in: Volume 9 / Year 2020 / Issue 4
Author(s): , , ,
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

Published in: Volume 9 / Year 2020 / Issue 2
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

Published in: Volume 9 / Year 2020 / Issue 2
Author(s): , ,
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 »

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