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Transforming healthcare: CinnaGen’s leadership in follow-on biologicals/biosimilars development and market expansion
Abstract: CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologic...
Physicochemical stability of Etoposide Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
Physicochemical stability of Doxorubicin Accord 2 mg/mL in punctured original vials and polypropylene syringes and after dilution with 0.9% sodium chloride or 5% glucose solution in polyethylene bottles
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
Physicochemical stability of Epirubicin Accord 2 mg/mL in punctured original vials and polypropylene syringes and after dilution with 0.9% sodium chloride or 5% glucose solution in polyolefine bags
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
Physicochemical stability of Docetaxel Accord 20 mg/mL concentrate diluted with 0.9% sodium chloride or 5% glucose solution in non-PVC bags
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
Physicochemical stability of Cytarabine Accord in punctured original vials and after dilution with 0.9% sodium chloride solution in polyolefine bags
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
Physicochemical stability of Cisplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride solution
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
Physicochemical stability of Carboplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride or 5% glucose solution
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
Physicochemical stability of Cabazitaxel Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution in non-PVC bottles
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
Physicochemical stability of Bortezomib Accord 2.5 mg/mL and diluted 1 mg/mL intravenous injection solution in punctured original vials and polypropylene syringes
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Abstrac...
Physicochemical stability of Azacitidine Accord 25 mg/mL suspension for injection in original vials and polypropylene syringes after reconstitution with refrigerated water for injection
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Abstrac...
The challenge for drug shortage: lessons learned from the quality issues of Japanese generic drug companies
Author byline as per print journal: Takanao Hashimoto1, PhD; Akihiko Ozaki2, MD, PhD; Hiroaki Saito3, MD; Erika Yamashita4...
US interchangeability designation: are we ready to cut the Gordian knot?
Author byline as per print journal: Joseph P Park1, PhD; Gillian R Woollett2, MA, DPhil Abstract: US Food and Drug Adminis...
Misinformation about interchangeable biosimilars: undermines US health policy, physician confidence, and patient health
Author byline as per print journal: Michael S Reilly, Esq; Ralph D McKibbin, MD, FACP, FACG, AGAF Abstract: The US biosimi...
Extended stability data on small molecule anticancer medicinal products – anything new? any additional information necessary?
Author byline as per print journal: Professor Irene Krämer, PhD; Judith Thiesen, PhD Abstract: Monoclonal antibodies and c...
First 2024 GaBI Journal issue highlights
It was with great pleasure that I assumed the role of Editor-in-Chief (EiC) of GaBI Journal in January of this year. Takin...
Aligning environmental, social, and governance to clinical development: moving towards more sustainable clinical trials
Author byline as per print journal: Sandeep N Athalye, MBBS, MD; Shylashree Baraskar; Shivani Mittra, MPharm, PhD; Elena W...
Preserve the US interchangeable standard that has helped drive physician and patient confidence in biosimilars
Abstract: The US FDA proposed eliminating the distinction between biosimilars and interchangeable biosimilars, aiming to a...
Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries
Author byline as per print journal: Pritha Paul1, PhD; Rahul Kapur2,*, MBBS, PhD; Shivani Mittra2, MPharm, PhD; Nimish Sha...
Comparative efficacy studies of biosimilars: data versus theoretical risks, beliefs, and comfort
Abstract: Ethnic sensitivity assessments in the form of bridging pharmacokinetics (PK) studies are often needed for biosim...
Budget impact analysis of a rituximab intravenous biosimilar in patients with follicular lymphoma and large B-cell non-Hodgkin lymphoma in Chile
Author byline as per print journal: Tomás Abbot1, MSc; Nicolás Armijo1, MSc; Robin Piron2, PhD; Manuel Espinoza1, 3, PhD I...
Current understanding, knowledge, and perception of biosimilars in a changing landscape of regulatory requirements
Author byline as per print journal: Andriy Krendyukov, MD, PhD; Marta Bakowska, BA (Hon), MPH; Dirk Schiller, PhD; Sanjay ...
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...
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
Biologics are the fastest-growing class of medications in the United States and account for a substantial and growing port...
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 scienti...
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...
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