BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements Journal title: The AAPS Journal Authors: Barbara M. Davit, Isadore Kanfer, Yu Chung Tsang, Jean-Michel Cardot Subject(s): Medicine
Antibody Drug Conjugates: Nonclinical Safety Considerations Journal title: The AAPS Journal Authors: Mary Jane Masson Hinrichs, Rakesh Dixit Subject(s): Medicine
How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider Journal title: The AAPS Journal Authors: Huub Schellekens, Sven Stegemann, Vera Weinstein, Jon S. B. de Vlieger, Beat Flühmann, Stefa... Subject(s): Medicine
Drug–Drug Interaction Studies: Regulatory Guidance and An Industry Perspective Journal title: The AAPS Journal Authors: Thomayant Prueksaritanont, Xiaoyan Chu, Christopher Gibson, Donghui Cui, Ka Lai Yee, Jeanine Ballard... Subject(s): Medicine
