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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...
A review of international initiatives on pharmaceutical regulatory reliance and recognition
Abstract: In light of recent global health challenges, the need for regulatory reliance — where one regulatory authority a...
Comment on the article by Reilly MS and McKibbin RD
Abstract: Reilly and McKibbin oppose the update of FDA interchangeability guidance that does not require clinical switch s...
Comment on ‘Misinformation about interchangeable biosimilars’
Author byline as per print journal: Hillel P Cohen, PhD; Caridad Pontes, MD, PhD; Fernando de Mora, MBA, PhD Abstract: The...
Third and final issue of GaBI Journal’s 13th volume
This third issue of GaBI Journal is the last of the volume for this year and marks the end of the first year of me taking ...
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: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
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: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
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: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
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: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
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: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
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: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
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: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
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: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
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: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Abstract: This study asses...
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: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Abstract: The physicochemi...
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 ...
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...
Comparative efficacy studies of biosimilars: data versus theoretical risks, beliefs, and comfort
Abstract: In principle, biosimilars could mitigate the problem of the rising cost of biological medicines. However, the cu...
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...
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...
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...
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...
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