Bioequivalence Evaluation of Orally Disintegrating Strips of Rizatriptan in Male Volunteers Under Fasting Conditions

Sapkal, Nidhi; Daud, Anwar; Bonde, Minal; Gawande, Mangesh; Gurav, Nilambari

doi:10.22159/ijap.2021v13i5.41602

Cited by 2 publications

(2 citation statements)

References 13 publications

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“…The accurate forecast was likewise determined by a fold error of less than two. In other research, a stricter technique known as the average bioequivalence criterion (90% confidence interval within 80-125%) was also used [79,80]. It is important to note that the intended usage and regulatory implications should strongly influence the scope of model validation and verification.…”

Section: Verification Of Modelmentioning

confidence: 99%

Virtual Bioequivalence in Pharmaceuticals: Current Status and Future Prospects

C.,

H.,

K. K.

2023

Int J App Pharm

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Virtual bioequivalence studies (VBE) can assess the similarity and potential differences in pharmacokinetic and clinical performance between test and reference formulations based on the translational relationship between in vitro, in silico, and in vivo. The crucial data from clinical trials can be delivered with the help of virtual bioequivalence research, which will speed up the creation of novel and generic medications. Virtual bioequivalence study regulation, however, has not yet reached its complete development. The current status of VBE studies in the market is booming and many pharmaceutical industries have started adapting to its benefits in submitting bioequivalence results for approval from regulatory bodies. FDA had regulated the guidelines for virtual bioequivalence, which the various regulatory agencies accept for the approval of filing ANDA. The importance of implementing VBE has benefited at present in saving cost and time; low workforce and failures can be neglected. Determining the framework for virtual bioequivalence studies for all medications and discussing the potential uses of virtual bioequivalence in the future to support the waiver and optimization of in vivo clinical trials are the main objectives of this review article.

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Section: Verification Of Modelmentioning

confidence: 99%

Virtual Bioequivalence in Pharmaceuticals: Current Status and Future Prospects

C.,

H.,

K. K.

2023

Int J App Pharm

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“…The dried extract was then reconstituted in 500 µl of diluents acetonitrile (ACN): Milli-Q Water (50:50), transported to an autosampler vial for LC-MS/MS analysis, and 10 µl of volume was injected. [25][26][27]…”

Section: Plasma Extraction Was Performed By Liquid-liquid Extraction ...mentioning

confidence: 99%

Determination of Metformin and Sitagliptin in Healthy Human Volunteers' Blood Plasma and Its Bioequivalence Study Under Fasting Condition

Das¹,

Halder

Bose³

et al. 2022

Int J App Pharm

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Objective: Metformin hydrochloride and sitagliptin are the oral anti-hyperglycemic medications used to treat type 2 diabetes and are used in combination to treat patients. In this work, we have developed a bioanalytical method for simultaneous estimation of both the drugs form some formulation and subsequently the validation of the developed method metformin and sitagliptin in human plasma. Methods: The stability studies were done as per USFDA and EMA guidelines. The sample extraction approach presented here was a straightforward liquid extraction. The linearity range of metformin was 11.72 ng/ml to 3000 ng/ml, and sitagliptin was 4.68 ng/ml. to 1200 ng/ml. For metformin, the LOD was 1.0 ng/ml, and LLOQ was 11.72 ng/ml. and for sitagliptin, the LOD was 0.75 ng/ml, and LLOQ was 4.68 ng/ml. LC-ESI-MS/MS was used to develop and validate this method using the Phenomenex Kinetex C18 column. Milli-Q water containing 10 mmol Ammonium Acetate (pH =3.6) and Acetonitrile containing 0.1% Formic Acid (pH =2.4) as solvent systems for the estimation of Sitagliptin in a single dose. Metoprolol is used as an Internal Standard. Results: The total chromatographic run time was only 7.0 min, and the elute time of metformin and sitagliptin was 3.94 min and 3.97 min, respectively. Relative Bioavailability was found at 101.14% for Metformin and 96.96% for Sitagliptin. The overall results show that the Cmax, AUC0-t, and AUC0-∞ for metformin and sitagliptin were within the acceptable limit of 80%-125%. Conclusion: This bioanalytical method was successfully applied in the bioequivalence study. The study design was a randomized, open-label, two treatment, two-period, two sequences, single-dose, crossover bioequivalence study under fasting conditions.

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Bioequivalence Evaluation of Orally Disintegrating Strips of Rizatriptan in Male Volunteers Under Fasting Conditions

Cited by 2 publications

References 13 publications

Virtual Bioequivalence in Pharmaceuticals: Current Status and Future Prospects

Virtual Bioequivalence in Pharmaceuticals: Current Status and Future Prospects

Determination of Metformin and Sitagliptin in Healthy Human Volunteers' Blood Plasma and Its Bioequivalence Study Under Fasting Condition

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