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Latest features in GaBI Journal, 2023, Issue 3
The articles in this issue of the GaBI ­Journal highlight two important issues that must be considered when reading scient...
Pharmacokinetic bioequivalence studies of a new Etoricoxib tablet formulation developed using proprietary MiST technology — risk assessment and mitigation using GastroPlus software
Author byline as per print journal: Dhananjay Panigrahi1, MPharm; Aditya Murthy2, MPharm, PhD; Shubham Jamdade2, MPharm; M...
Switches between biosimilars and their reference products
Submitted: 22 November 2023; Revised: 24 November 2023; Accepted: 27 November 2023; Published online first: 28 November 20...
Infliximab discontinuation in patients with originator retransition vs. biosimilar continuation
Submitted: 4 November 2023; Revised: 24 November 2023; Accepted: 27 November 2023; Published online first: 28 November 202...
Trends in Saudi FDA drug approvals and GMP inspections: an observational study
Author byline as per print journal: Dr Ali M Alhomaidan; Mohammed Abdulaziz Alageel; Turki Abdulaziz Alrafie; Hassan Moham...
The incorporation of the Halal Management System (HMS) by the pharmaceutical industry
Author byline as per print journal: Ka-Liong Tan1, DPhil; Ainoon Othman1; Irwan Mohd Subri3; Noor Fadzilah Zulkifli1; Mohd...
Biosimilar antibody drug conjugates: considerations of higher order structure and aggregation
Abstract: Undoubtedly the complexity of Antibody Drug Conjugate (ADC) molecules where three components (monoclonal antibod...
Medicare drug price negotiations: impact on healthcare development and patient access to medicines
Author byline as per print journal: Michael S Reilly, Esq; Thomas R Barker, Esq, JD; Charles M Clapton, Steven J Potts, Ph...
Extrapolation requires reading between the lines
The articles in this second issue of 2023 include an Original Research study (Internet questionnaire) of the ‘opinions’ of...
Follow-on biologicals/biosimilars approved in Brazil: May 2023 update
Abstract: Brazilian requirements for approval of biosimilars are aligned with a strict regulatory process and ensure the s...
Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not?
Author byline as per print journal: Sandeep N Athalye1, MBBS, MD; Dev B Baruah1, MPharm; Shivani Mittra1, MPharm, PhD; Ank...
Canadian prescribers’ attitudes and perceptions about ophthalmic biosimilars
Author byline as per print journal: Michael S Reilly, Esq; Jane Barratt, PhD Introduction: The first biosimilar entered th...
Statistical tests for detecting reference product change in biosimilar studies
Author byline as per print journal: Jiayin Zheng1, PhD; Peijin Wang2, MS; Yixin Wang3, PhD; Shein-Chung Chow2, PhD Abstrac...
Lagging acceptance of generic and biosimilar drug products; the rest of the story
The articles in this issue of the GaBI Journal reminded me of The Rest of the Story radio programme originally hosted by M...
Non-medical switching of biologicals/biosimilars Canada, Europe and the US: a webinar report
Author byline as per print journal: Michael S Reilly, Esq; Gail Attara; Ralph D McKibbin, MD, FACP, FACG, AGAF; Professor ...
Biosimilars approved in Brazil 2022
Author byline as per print journal: Sílvia Helena Cestari de Oliveira, MSc Abstract: In Brazil, a legal framework for appr...
Pharmacokinetics and relative bioavailability of sitagliptin hydrochloride and sitagliptin phosphate tablets formulations: a randomized, open-label, crossover study in healthy male volunteers
Author byline as per print journal: Chuei Wuei Leong, PhD; Elton Sagim, BBiomedSc, Kar Ming Yee, BPharm; Muhammad Shalhadi...
Biosimilars drug development: time for a paradigm shift?
Author byline as per print journal: Sandeep N Athalye, MS; Shivani Mittra, MPharm, PhD; Ankitkumar M Ranpura, MD Abstract:...
Response to the Opinion entitled ‘Biosimilars drug development: time for a paradigm shift?’
Abstract: The Opinion published in this issue of GaBI Journal titled 'Biosimilars drug development: time for a paradi...
The importance of trust
It seems as if the entire world is dealing with a lack of trust, even in many things that have enriched and sustained huma...
Social trust and regional variation in the adoption of biosimilars in Italy and Germany
Author byline as per print journal: James C. Robinson, PhD, MPH Introduction/Study Objectives: Adoption of biosimilars has...
Pharmacokinetic bioequivalence of sitagliptin phosphate tablet formulations: a randomized, open-label, crossover study in healthy volunteers
Author byline as per print journal: Chuei Wuei Leong*,1, PhD; Elton Sagim1, BBiomedSc; Kar Ming Yee1, BPharm; Muhammad Sha...
Development of Ph. Eur. standards for therapeutic monoclonal antibodies: infliximab case study
Keywords: Monoclonal antibodies, pharmacopoeia, infliximab, public standards, flexibility Author byline as per print journ...
Key factors for successful uptake of biosimilars: Europe and the US
Introduction: Biosimilars were first introduced in Europe in 2006 and then in the US in 2015. An online webinar on the suc...
What to look forward to in GaBI Journal, 2022, Issue 2
The rate of successful development, regulatory approval and marketing of both new and follow-on biological treatments has ...
US prescribers’ attitudes and perceptions about biosimilars
Author byline as per print journal: Ralph McKibbin, MD; Michael S Reilly, Esq Introduction: In the United States (US), a l...
Social trust, economic incentives, and regional variation in the adoption of biosimilars in italy and germany
Author byline as per print journal: James C. Robinson, PhD, MPH Introduction/Study Objectives: Adoption of biosimilars has...
Key factors for successful uptake of biosimilars: Europe and US
Author byline as per print journal: Michael S Reilly, Esq; Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP Introduct...
Front-loading biosimilar development with analytical characterization
Abstract: An online roundtable discussion entitled 'Front-loading biosimilar development with analytical characteriza...
On statistical evaluation for interchangeability of biosimilar products
Author byline as per print journal: Yuqi Li, BS Pharm; Professor Shein-Chung Chow, PhD Abstract: A biosimilar product is a...
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