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Boujbel Mohamed Amine
Les Laboratoires Medis, Nabeul, Tunisia
Publications
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Research Article
Biopharmaceutics Classification System (BCS) Based Biowaiver Studies of Lenalidomide Capsules (25 mg) – An Alternative to In vivo Bioequivalence Studies for Generic Oncology Drug Products
Author(s): AlSwisi Mahmoud*, Boujbel Lassaad and Boujbel Mohamed Amine
Lenalidomide, commercialized as Revlimid®, is an immunomodulatory drug, approved as a therapy for Multiple Myeloma and deletion 5q Myelodysplastic syndromes. This molecule shows a promising therapeutic potential in other hematologic malignancies. According to the European Medicines Agency (EMA), lenalidomide is considered as a fully absorbed drug substance, however, there is no sufficient data on solubility that enables its BCS classification. Therefore, as per the International Council for Harmonization (ICH) guideline, a solubility study has been done by Les Laboratoires Medis to prove that lenalidomide is a highly soluble compound. This demonstration requires the investigation in different buffer solutions within the range of pH 1- 6.8 (including pKa) at 37 ± 1°C and we have proceeded with a nominal concentration (1.0 mg/ml) which repr.. View more»