Articles

Review Article

Published on 18 November 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

authorization, best practice, harmonization, pharmaceuticals, recognition

DOI: 10.5639/gabij.2024.1303.034

2.050 views

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Interview

Published on 07 November 2024

Transforming health care: 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 (Middle East and North Africa)

DOI: 10.5639/gabij.2024.1303.037

929 views

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Special Report

Published on 06 May 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

Abstract: The physicochemical stability of Azacitidine Accord, a pyrimidine analogue antineoplastic agent, was assessed after reconstitution with cold water for injection (WFI) and storage in original glass vials and polypropylene...

Author(s): Irene Krämer, PhD, Frank Erdnuess, PhD, Judith Thiesen, PhD

azacitidine, physicochemical stability, suspension for injection

DOI: 10.5639/gabij.2024.1302.023

1.175 views

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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

727 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

804 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

1.267 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

1.118 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

1.010 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

924 views

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Special Report

Published on 11 September 2024

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 determine the physicochemical stability of Epirubicin Accord 2 mg/mL concentrate in original...

concentrated solution, diluted infusion solution, epirubicin, physicochemical stability

DOI: 10.5639/gabij.2024.1302.012

693 views

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Special Report

Published on 11 September 2024

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 determine the physicochemical stability of Doxorubicin Accord 2 mg/mL concentrate in original...

concentrated solution, diluted infusion solution, doxorubicin, physicochemical stability

DOI: 10.5639/gabij.2024.1302.011

1.077 views

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Special Report

Published on 11 September 2024

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 determine the physicochemical stability of Etoposide Accord concentrate in punctured vials and...

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

DOI: 10.5639/gabij.2024.1302.018

797 views

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