Investigation on the need of multiple dose bioequivalence studies for prolonged-release generic products

García‐Arieta, Alfredo; Morales‐Alcelay, Susana; Herránz, Marta; Torre-Alvarado, José María de la; Blázquez-Pérez, Antonio; Suárez-Gea, Ma Luisa; Álvarez, C.

doi:10.1016/j.ijpharm.2011.11.022

Cited by 13 publications

(9 citation statements)

References 8 publications

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“…Moreover, bioequivalence need only be tested in normal healthy subjects, not the intended patient population. In addition, single‐dose studies in healthy volunteers may not predict steady‐state bioequivalence in patients, particularly for modified‐release forms . Administrative claims data and health records can be used to surveil health services use and drug discontinuation after brand‐to‐generic switching, along with other postmarketing data, as surrogates for equivalence testing.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, single-dose studies in healthy volunteers may not predict steadystate bioequivalence in patients, particularly for modified-release forms. 36 Administrative claims data and health records can be used to surveil health services use and drug discontinuation after brandto-generic switching, 37 along with other postmarketing data, as surrogates for equivalence testing. However, there are relatively few randomized trials, like the present one, comparing clinical outcomes of generic and brand drugs.…”

Section: Discussionmentioning

confidence: 99%

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Bioequivalence and Therapeutic Equivalence of Generic and Brand Bupropion in Adults With Major Depression: A Randomized Clinical Trial

Kharasch

Neiner

Kraus

et al. 2019

Clin Pharma and Therapeutics

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Controversy persists about bupropion XL 300 mg generic equivalence to brand product. A prospective, randomized, double‐blinded crossover in 70 adults with major depression in stable remission taking any bupropion XL 300 mg tested bioequivalence and therapeutic equivalence of available XL 300 mg products. After a 4‐week lead‐in on patients' existing bupropion, four 6‐week phases evaluated brand and three generics. Patients were uninformed of switching. Drug overencapsulation ensured blinding. There were no differences between any generic and brand, or between generics, in peak plasma concentration (Cmax) and area under the plasma concentration‐time curve over the 24‐hour dosing interval (AUC0–24) for racemic bupropion or major metabolites. All generics met formal bioequivalence criteria for bupropion and metabolites. There were no differences between generics and brand, or between generics, in depression symptoms or side effects, assessed by every 3‐week in‐person interview and daily smartphone‐based self‐report. There were no differences in patients' perceptions of bupropion products. Results show three bupropion XL 300 mg generic products are both bioequivalent and not therapeutically different from brand drug and each other.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Bioequivalence and Therapeutic Equivalence of Generic and Brand Bupropion in Adults With Major Depression: A Randomized Clinical Trial

Kharasch

Neiner

Kraus

et al. 2019

Clin Pharma and Therapeutics

View full text Add to dashboard Cite

show abstract

“…It was recently demonstrated that steadystate studies can detect differences between formulations when single doses are not able to do so (45). Consequently, it is unclear whether, for these MR formulations, single-dose BE investigations fully ensure their therapeutic equivalence.…”

Section: Single or Multiple Drug Administrationmentioning

confidence: 99%

“…However, another recent study found that C τ was, in some cases, not sensitive to detect differences between MR products and that multiple-dose studies rather than single-dose investigations were necessary to ensure therapeutic equivalence (45).…”

Section: Single or Multiple Drug Administrationmentioning

confidence: 99%

Metrics for the Evaluation of Bioequivalence of Modified-Release Formulations

Endrényi

Tóthfalusi

2012

AAPS J

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Abstract. Metrics are discussed which are used for the evaluation of bioequivalence of modifiedrelease formulations. In order to ensure the therapeutic equivalence of the compared drug products, it would be important to contrast measures which are additional to area under the curve (AUC) and C max . For delayed-release products, the assessment of lag times is informative. For extended-release dosage forms, comparisons of the half-value duration and the midpoint duration time are useful. For some modified-release formulations with complicated, multiphasic concentration profiles, the comparison of partial AUCs is important. In determinations of the bioequivalence of extended-release dosage forms, investigations performed under steady-state conditions rather than after single dosing can yield enhanced probability of therapeutic equivalence, especially with substantial accumulation of the drug products. In steady-state investigations of bioequivalence, evaluation of the trough concentration and of the peak trough fluctuation is informative.

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“…Prilikom procene potrebe za izvođenjem studije bioekvivalencije treba uzeti u obzir parametre koji se odnose kako na lekovitu supstancu, tako i na farmaceutski oblik leka. [40,56,57]. Ovakav način ispitivanja se primenjuje i u slučaju veoma niskih koncentracija leka, kao i nedostatka dovoljno osetljive analitičke metode za merenje koncentracije leka u biološkom materijalu [35].…”

Section: Studije Biološke Ekvivalentnostiunclassified

Biopharmaceutical characterization of levothyroxine sodium immediate-release tablets

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Investigation on the need of multiple dose bioequivalence studies for prolonged-release generic products

Cited by 13 publications

References 8 publications

Bioequivalence and Therapeutic Equivalence of Generic and Brand Bupropion in Adults With Major Depression: A Randomized Clinical Trial

Bioequivalence and Therapeutic Equivalence of Generic and Brand Bupropion in Adults With Major Depression: A Randomized Clinical Trial

Metrics for the Evaluation of Bioequivalence of Modified-Release Formulations

Biopharmaceutical characterization of levothyroxine sodium immediate-release tablets

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