


An Effective Approach to Assess Bioequivalence of Fingolimod in Normal Healthy Volunteers Using 0.5 mg Study Dose
An Effective Approach to Assess Bioequivalence of Fingolimod in Normal Healthy Volunteers Using 0.5 mg Study Dose PRESENTED TO: BioPharma Services Inc.PRESENTED BY: R. Chandani, J. He, F. Trabelsi PURPOSE Fingolimod is indicated for the treatment of patients with...
Challenge with New FDA Requirement for Partial AUCs for Bioequivalence Assessment of Modified-Release Products
Challenge with New FDA Requirement for Partial AUCs for Bioequivalence Assessment of Modified-Release Products PRESENTED TO: BioPharma Services Inc., Toronto, ON, CanadaPRESENTED BY: Juan He, Priscila Pequeno, Yu Ding, Rabiya Chandani, Negar Gharavi, and Fethi...
Clinical Study Program for 505(b)2 NDA Application – The Fast Path to Approval
Clinical Study Program for 505(b)2 NDA Application – The Fast Path to Approval PRESENTED AT: CSPS Annual Conference, Toronto, Canada (June 2009)PRESENTED BY: Juan He*, Masood Bhatti, and Lorelei Lutter, BioPharma Services Inc. Toronto, ONT, Canada ABSTRACT The...
The investigation of variability of the pharmacokinetics of mesalamine from mesalamine formulations
The investigation of variability of the pharmacokinetics of mesalamine from mesalamine formulations PRESENTED TO: BioPharma Services Inc.PRESENTED BY: Juan He*, Masood Bhatti, and Lorelei Lutter ABSTRACT Purpose: Mesalamine, which is also called 5-aminosalicylic acid...
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