The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the fifth international EUFEPS/AAPS conference

Mehta, Mehul; Schug, Barbara; Blume, HH; Beuerle, Gerald; Jiang, Wenlei; Koenig, Janet; Paixão, Paulo; Tampal, Nilufer; Tsang, Y-C; Wedemeyer, Ralph-Steven; Welink, Jan

doi:10.1016/j.ejps.2023.106566

Cited by 4 publications

(6 citation statements)

References 53 publications

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“…As a comparison, approximately 69.8% of EMA PSGs for IR solid oral products recommend a fasting BE study, 14.3% recommend a fed BE study, and 15.9% recommend both fasting and fed BE studies (Table 2). The PK BE study recommendation with regard to food represents an area that is significantly different between FDA and EMA, and other regulatory agencies 11–13 …”

Section: Resultsmentioning

confidence: 99%

“…The PK BE study recommendation with regard to food represents an area that is significantly different between FDA and EMA, and other regulatory agencies. [11][12][13] There may be special consideration in the products' labeling on how to take the drug product for ODTs, chewable and effervescent tablets, oral powders, and troches/ lozenges. Administrative instructions were found to not be consistent among different products of the same dosage form.…”

Section: Special Administration Considerations In Ema Psgsmentioning

confidence: 99%

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Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development

Kotsybar,

Hakeem,

Zhang

et al. 2023

Clinical Translational Sci

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Immediate‐release (IR) solid oral drug products constitute a significant portion of approved drug products and products under development. Bioequivalence (BE) assessment for these oral products is important for establishing therapeutic equivalence for generic products to their respective comparator products. In December 2022, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published the first new draft guideline on BE for IR solid oral dosage forms (M13A). To support the development of ICH M13A, we comprehensively reviewed the landscape of oral IR products approved by the U.S. Food and Drug Administration (FDA) and compared BE recommendations for these products in the current U.S. FDA and European Medicines Agency (EMA) BE guidances. We utilized databases including Drugs@FDA, Orange Book, and product‐specific guidances (PSGs) published on the U.S. FDA and EMA websites to collect information. Oral IR products account for 46% of all FDA‐approved new drug applications currently listed in Orange Book with 82.5% solids, 0.9% semi‐solids, and 16.6% liquids. For all published U.S. FDA PSGs for solid oral IR products, in vivo BE studies with pharmacokinetic (PK) endpoints account for 88% of BE approaches recommended. Of these PK BE studies, 86.5% recommended fasting and fed BE studies, while only 15.9% EMA PSGs recommended both fasting and fed BE studies. This review helps clarify the scope of U.S. solid oral IR products impacted by the new ICH M13A draft guideline and demonstrates how recommendations in draft ICH M13A could significantly harmonize BE recommendations for IR oral products to facilitate global drug development.

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Section: Resultsmentioning

confidence: 99%

Section: Special Administration Considerations In Ema Psgsmentioning

confidence: 99%

Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development

Kotsybar,

Hakeem,

Zhang

et al. 2023

Clinical Translational Sci

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“…However, in pharmacokinetic applications, including bioequivalence studies, many samples are analyzed regularly. To manage some scenarios, including transferring the samples to the legal authorities, the bioequivalence centers must be forced to comply with regulations to ensure the reliability of the data. , …”

Section: Introductionmentioning

confidence: 99%

“…To manage some scenarios, including transferring the samples to the legal authorities, the bioequivalence centers must be forced to comply with regulations to ensure the reliability of the data. 20,21 In this study, levofloxacin (LEV) was selected as a model molecule, and a liquid chromatography−mass spectrometry (LC-MS)-based analytical method was developed for the quantification of LEV in rabbit blood plasma based on intravenous (IV) administration. Although LC-MS methods have been reported to analyze LEV from plasma in previous studies, this study is the first to analyze the FPSE of LEV from blood plasma.…”

Section: Introductionmentioning

confidence: 99%

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Adapting Fabric Phase Sorptive Extraction as an Innovative Multitool for Sample Transfer and Extraction in Pharmacokinetic Analysis Followed by LC-MS Determination of Levofloxacin in Plasma Samples

Ekin Dolaksız,

Kaynak,

Kabir

et al. 2024

ACS Omega

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Fabric phase sorptive extraction (FPSE) is a simple microextraction technique that allows analytes to be rescued from matrix components while using a small volume of samples to analyze complex biological systems. This study used FPSE as a microextraction tool and a sample storage and transfer device. Levofloxacin as a model molecule was applied intravenously (IV) to New Zealand male rabbits. The samples were simultaneously extracted by using FPSE and protein precipitation methods. The final solutions were analyzed using LC-MS equipped with an ACE C18 LC Column (150 mm × 4.6 mm, 5 μm) at 25 °C employed in isocratic elution mode using solution A (0.1% formic acid in water)/solution B (0.1% formic acid in acetonitrile) (80:20, v/v). The total analysis time was less than 15 min. The developed method was validated using the ICH M10 bioanalytical method validation and study sample analysis guidelines. The results obtained using FPSE were statistically identical to those obtained using protein precipitation. The plasma samples applied onto FPSE (10 μL onto 1.0 cm × 1.0 cm Biofluid Sampler) were stored in three different temperatures [refrigerator (2−8 °C), at ambient temperature (20 ± 5 °C), and in the stability cabinet (40 °C, 75% humidity)] and three different storage conditions (Eppendorf tubes, plastic containers, and straw paper envelopes). Levofloxacin in plasma samples adsorbed by FPSE biofluid sampler remained stable at 2−8 °C in Eppendorf tubes for at least 1 week. This study showed that FPSE could be used as a sample storage and transfer device for pharmacokinetic applications that need to work with small sample volumes and discard aggressive cold chains to store and transfer the plasma samples.

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Open forum conference on the ICH M13A bioequivalence guideline

Blume,

Wedemeyer,

Seidlitz

et al. 2024

European Journal of Pharmaceutical Sciences

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The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the fifth international EUFEPS/AAPS conference

Cited by 4 publications

References 53 publications

Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development

Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development

Adapting Fabric Phase Sorptive Extraction as an Innovative Multitool for Sample Transfer and Extraction in Pharmacokinetic Analysis Followed by LC-MS Determination of Levofloxacin in Plasma Samples

Open forum conference on the ICH M13A bioequivalence guideline

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