Journal of Bioequivalence & Bioavailability

Dalia Jawhari

Publications

• Research Article
  Bioequivalence of a New Generic Formulation of Erlotinib Hydrochloride 150 mg Tablets versus Tarceva in Healthy Volunteers under Fasting Conditions
  Author(s): Dalia Jawhari, Mahmoud Alswisi, Mahmoud Ghannam and Jamil Al HalmanDalia Jawhari, Mahmoud Alswisi, Mahmoud Ghannam and Jamil Al Halman
  
  Erlotinib is a potent and highly selective inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase used in the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) and was recently approved for use in combination with gemcitabine. A single center, randomized, single dose, laboratory-blinded, 2-period, 2‑sequence, crossover design bioequivalence study was conducted in 36 fasting, healthy volunteers to compare pharmacokinetics profile of a new Erlotinib generic formulation (Erlotinib tablets 150 mg, Hikma Pharmaceuticals) with those of the reference product(Tarceva, OSI Pharmaceuticals, USA). The study was performed by CRO PHARMA MEDICA RESEARCH INC. (Canada) in accordance with Good Clinical Practices and the applicable regulatory requirements. One tablet of each formulation was administered with water after a 10 hour overnigh.. View More»
  DOI: 10.4172/jbb.1000190

  Abstract PDF