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
In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches Journal title: The AAPS Journal Authors: Ben Forbes, Per Bäckman, David Christopher, Myrna Dolovich, Bing V. Li, Beth Morgan Subject(s): Medicine
Antibody Drug Conjugates: Nonclinical Safety Considerations Journal title: The AAPS Journal Authors: Mary Jane Masson Hinrichs, Rakesh Dixit Subject(s): Medicine
Model-Based Determination of Effective Blood Concentrations of Cyclosporine for Neutrophil Response in the Treatment of Severe Aplastic Anemia in Children Journal title: The AAPS Journal Authors: Michaël Philippe, Emilie Hénin, Yves Bertrand, Dominique Plantaz, Sylvain Goutelle,... Subject(s): Medicine
Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India Journal title: The AAPS Journal Authors: Sau L. Lee, Bhawana Saluja, Alfredo García-Arieta, Gustavo Mendes Lima Santos, Ying Li, Sara... Subject(s): Medicine
Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products: Overview of the IPAC-RS/University of Florida Orlando Inhalation Conference Journal title: The AAPS Journal Authors: Guenther Hochhaus, Craig Davis-Cutting, Martin Oliver, Sau L. Lee, Svetlana Lyapustina Subject(s): Medicine
Drug Delivery Approaches in Addressing Clinical Pharmacology-Related Issues: Opportunities and Challenges Journal title: The AAPS Journal Authors: Hong Wen, Huijeong Jung, Xuhong Li 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
Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars? Journal title: The AAPS Journal Authors: Howard Lee Subject(s): Medicine
Ethinyl Estradiol and Other Human Pharmaceutical Estrogens in the Aquatic Environment: A Review of Recent Risk Assessment Data Journal title: The AAPS Journal Authors: James P. Laurenson, Raanan A. Bloom, Stephen Page, Nakissa Sadrieh Subject(s): Medicine
Similarities and Differences of International Guidelines for Bioequivalence: an Update of the Brazilian Requirements Journal title: The AAPS Journal Authors: Camila Fracalossi Rediguieri, Rodrigo Cristofoletti, Kelen Carine Costa Soares, João Tavares... Subject(s): Medicine
Regulatory Administrative Databases in FDA's Center for Biologics Evaluation and Research: Convergence Toward a Unified Database Journal title: The AAPS Journal Authors: Jeffrey K. Smith 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
A Report from the Pediatric Formulations Task Force: Perspectives on the State of Child-Friendly Oral Dosage Forms Journal title: The AAPS Journal Authors: Anne Zajicek, Michael J. Fossler, Jeffrey S. Barrett, Jeffrey H. Worthington, Robert Ternik, Georgia... Subject(s): Medicine
International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences Journal title: The AAPS Journal Authors: Barbara Davit, April C. Braddy, Dale P. Conner, Lawrence X. Yu Subject(s): Medicine
