Journal of Bioequivalence & Bioavailability

Boujbel Lassaad

Publications

• 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 AmineAlSwisi 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»
  DOI: 10.35248/0975-0851.19.11.386

  Abstract PDF