Articles

Editor's Letter

Published on 17 January 2025

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 up the Editor-in-Chief position...

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2024.1303.032

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Review Article

Published on 05 December 2024

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 accepts the decisions of another – has gained significant interest and momentum....

Author(s): Vimal Sachdeva, MSc

DOI: 10.5639/gabij.2024.1303.034

1.006 views

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Interview

Published on 31 October 2024

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 biologicals/biosimilars. Dr Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI (Generics and Biosimilars Initiative)...

Author(s): GaBI Journal Editor

biosimilars, clinical development, commercialization, MENA

DOI: 10.5639/gabij.2024.1303.037

730 views

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Special Report

Published on 11 September 2024

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 physicochemical stability of Azacitidine Accord, a pyrimidine analogue antineoplastic agent, was assessed after...

azacitidine, physicochemical stability, suspension for injection

DOI: 10.5639/gabij.2024.1302.023

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Special Report

Published on 11 September 2024

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 assessed the physicochemical stability of Bortezomib Accord 2.5 mg/mL solutions for subcutaneous and intravenous injection...

bortezomib, intravenous injection, physicochemical stability, subcutaneous injection

DOI: 10.5639/gabij.2024.1302.015

583 views

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Special Report

Published on 11 September 2024

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 determine the physicochemical stability of undiluted Cabazitaxel Accord in punctured original vials...

cabazitaxel, concentrated solution, diluted infusion solution, HPLC, physicochemical stability

DOI: 10.5639/gabij.2024.1302.027

690 views

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Special Report

Published on 11 September 2024

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 determine the physicochemical stability of undiluted Carboplatin Accord 10 mg/mL in punctured...

carboplatin, concentrated solution, diluted infusion solution, HPLC, physicochemical stability

DOI: 10.5639/gabij.2024.1302.020

638 views

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Special Report

Published on 11 September 2024

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 determine the physicochemical stability of undiluted Cisplatin Accord 1 mg/mL in punctured...

cisplatin, concentrated solution, diluted infusion solution, HPLC, physicochemical stability

DOI: 10.5639/gabij.2024.1302.021

716 views

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Special Report

Published on 11 September 2024

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 determine the physicochemical stability of Cytarabine Accord 100 mg/mL in punctured original...

concentrated solution, cytarabine, diluted infusion solution, physicochemical stability

DOI: 10.5639/gabij.2024.1302.024

611 views

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Special Report

Published on 11 September 2024

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 determine the physicochemical stability of Docetaxel Accord infusion solutions 0.3 mg/mL and...

diluted infusion solution, docetaxel, HPLC, physicochemical stability

DOI: 10.5639/gabij.2024.1302.028

609 views

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