Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Gemcitabine Accord 100 mg/mL concentrate in original vials after first opening and after dilution with 0.9% sodium chloride solution in polyolefine (PO) bags at concentrations of 0.1 mg/mL and 10 mg/mL. Methods:…

concentrated solution, diluted infusion solution, gemcitabine, physicochemical stability

DOI: 10.5639/gabij.2024.1302.026

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of undiluted Idarubicin Accord in punctured original vials and polypropylene syringes as well as after dilution with water for injection (WFI) in polyolefine (PO) bags at three different concentrations (0.1 mg/mL, 0.62 mg/mL,…

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

DOI: 10.5639/gabij.2024.1302.013

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of undiluted Irinotecan Accord concentrate in punctured original glass vials, in polypropylene (PP) syringes, and after dilution with 0.9% sodium chloride solution or 5% glucose solution in polyolefine (PO) bags at different concentrations…

concentrated solution, diluted infusion solution, irinotecan, physicochemical stability

DOI: 10.5639/gabij.2024.1302.016

Author byline as per print journal: Irene Krämer, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Methotrexate Accord 25 mg/mL concentrate in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution in 100 mL non-PVC bags containing 0.1 mg/mL and 20 mg/mL methotrexate stored at different…

concentrated solution, diluted infusion solution, methotrexate, physicochemical stability

DOI: 10.5639/gabij.2024.1302.029

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To assess the physicochemical stability of Mitoxantrone Accord after dilution with 0.9% sodium chloride infusion solution to concentrations of 0.1 mg/mL and 0.6 mg/mL in polyolefine (PO) bags. Methods: Test solutions were aseptically prepared and stored light protected…

diluted infusion solution, HPLC, mitoxantrone, physicochemical stability

DOI: 10.5639/gabij.2024.1302.014

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Oxaliplatin Accord 5 mg/mL in punctured original vials and after dilution with 5% glucose solution in polyethylene (PE) bottles and polyolefine (PO) bags at different concentrations and different storage conditions. Methods: Test…

concentrated solution, diluted infusion solution, oxaliplatin, physicochemical stability

DOI: 10.5639/gabij.2024.1302.022

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Abstract: In this study, the physicochemical stability of Pemetrexed Accord 25 mg/mL concentrate and its diluted infusion solutions was examined under various storage conditions. Pemetrexed Accord 25 mg/mL remained physicochemically stable for 28 days when stored protected from light in…

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

DOI: 10.5639/gabij.2024.1302.030

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Topotecan Accord 1 mg/mL concentrate diluted with 0.9% sodium chloride solution or 5% glucose solution in non-PVC and polyolefine (PO) bags to three different concentrations (0.025 mg/mL, 0.1 mg/mL, 0.5 mg/mL) and…

diluted infusion solution, HPLC, physicochemical stability, topotecan

DOI: 10.5639/gabij.2024.1302.017

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Vinorelbine Accord in original vials after first puncture and after dilution to concentrations between 0.1 mg/mL and 3.0 mg/mL in commonly used infusion fluids and containers. Methods: Test solutions were prepared aseptically,…

HPLC, physicochemical stability, vinorelbine

DOI: 10.5639/gabij.2024.1302.019

Editor's Letter

Published on 10 September 2024

What to look forward to in GaBI Journal, 2024, Issue 2

Issue 2 of Volume 13 of GaBI ­Journal starts with a Review Article by Paul et al., titled ‘Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries’. The review focuses on treatment of non-communicable diseases as these disproportionately affect people living in low- and middle-income countries compared to high-income countries. Challenges…

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2024.1302.007

Abstract:This paper examines the repercussions of recent quality and regulatory crises in Japan’s generic pharmaceutical sector, focusing on incidents involving Sawai Group Holdings (Sawai GHD) and other manufacturers. It provides a comprehensive analysis of the consequences stemming from lapses in good manufacturing practice (GMP) compliance, particularly highlighted by the case of teprenone capsules 50 mg…

Author(s): Takanao Hashimoto, PhD, Akihiko Ozaki, MD, PhD, Hiroaki Saito, MD, Erika Yamashita, Tetsuya Tanimoto, MD, Professor Mihajlo Jakovljevic, MD, PhD, MAE

COVID-19 pandemic, drug shortages, generic drugs, good manufacturing practice, pharmaceutical policy

DOI: 10.5639/gabij.2024.1303.036

Abstract:US Food and Drug Administration’s (FDA) current thinking on interchangeability has evolved since the legal designation was first created in 2010. Based on experience, FDA now acknowledges that clinical switching studies are not generally needed for the interchangeability designation as quality, safety and efficacy are established by biosimilarity already. Approval pathways for biosimilars and interchangeable…

Author(s): Gillian R Woollett, MA, DPhil, Joseph P Park, PhD

biosimilars, BPCIA, interchangeability, market exclusivity, quality, switching

DOI: 10.5639/gabij.2024.1303.035