Unsuspected polymorphic metabolism of rupatadine via its primary metabolite, desloratadine

Srinivas, Nuggehally R.

doi:10.3132/pcrj.2009.00004

Cited by 3 publications

(1 citation statement)

References 6 publications

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“…Additionally, the existence of such genetic polymorphism may go unnoticed for considerable time due to lack of appropriate study population as evidenced by lack of literature citations on this aspect of rupatadine's metabolism until recently. [14,17] While more publications of these types of DDI studies would provide a strong base to appreciate the complexities involved in the polymorphic metabolism of primary metabolite(s), it is prudent to adopt a study design that provides the right balance in achieving the study objectives if existence of polymorphic metabolism is suspected in the disposition of primary metabolite without risking a study failure to unsuspected "polymorphic" metabolism.…”

Section: Bioequivalence Study Design Considerationsmentioning

confidence: 99%

Assessment of polymorphic metabolite data in bioavailability/bioequivalence studies - considerations and challenges

Srinivas¹

2011

Asian J Pharm

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B ioavailability (BA)/ bioequivalence (BE) studies are the cornerstone for the approval of generic drugs. While BA/BE assessment involving the pharmacokinetic data of the parent compound has been routinely performed, the introduction of the assessment of metabolite(s) data, alone or in addition to parent compound, has also emerged. In this context, the assessment of BA/BE of metabolite(s) may pose additional complexities and challenges, if the metabolic pathway is under the influence of a polymorphic enzyme. This communication provides brief perspectives on the challenges and study design considerations for the assessment of polymorphic metabolite in BA/BE studies.

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Section: Bioequivalence Study Design Considerationsmentioning

confidence: 99%

Assessment of polymorphic metabolite data in bioavailability/bioequivalence studies - considerations and challenges

Srinivas¹

2011

Asian J Pharm

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Metabolic considerations of drugs in the treatment of allergic diseases

García‐Martín

Cantó

Agúndez

2013

Expert Opinion on Drug Metabolism & Toxicology

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Poly-functional anti-allergic activities of anti-histamine drug - rupatadine

Гущин¹

2012

Russian Journal of Allergy

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Rupatadine is a new agent for the management of diseases with allergic inflammatory conditions. Rupatadine is a dual inhibitor of H 1- and platelet-activating factor (PAF)-receptors and possesses a broader profile of antiallergic properties inhibiting allergy target cells and secretion of different mediators involved in the early- and late-phase of allergic response. Rupatadine is a real example of poly-functional anti-allergic remedy.

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Unsuspected polymorphic metabolism of rupatadine via its primary metabolite, desloratadine

Cited by 3 publications

References 6 publications

Assessment of polymorphic metabolite data in bioavailability/bioequivalence studies - considerations and challenges

Assessment of polymorphic metabolite data in bioavailability/bioequivalence studies - considerations and challenges

Metabolic considerations of drugs in the treatment of allergic diseases

Poly-functional anti-allergic activities of anti-histamine drug - rupatadine

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