Znowelizowana wytyczna European Medicines Agency na temat badań równoważności biologicznej Journal title: CHEMIK nauka-technika-rynek Authors: Monika Bogiel Subject(s):
THE BIOPHARMACEUTICAL CLASSIFICATION SYSTEM (BCS): PRESENT STATUS AND FUTURE PROSPECTIVES Journal title: International Research Journal of Pharmacy (IRJP) Authors: Vikaas Budhwaar , Arun Nanda Subject(s):
Amended guideline of the European Medicines Agency on the investigation of bioequivalence Journal title: CHEMIK nauka-technika-rynek Authors: Monika Bogiel Subject(s):
Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications Journal title: The AAPS Journal Authors: Sandra Suarez-Sharp, Poonam R. Delvadia, Angelica Dorantes, John Duan, Anna Externbrink, Zongming Ga... Subject(s): Medicine
Survey of International Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products Journal title: The AAPS Journal Authors: April C. Braddy, Barbara M. Davit, Ethan M. Stier, Dale P. Conner 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
Scientific Perspectives on Extending the Provision for Waivers of In vivo Bioavailability and Bioequivalence Studies for Drug Products Containing High Solubility-Low Permeability Drugs (BCS-Class 3) Journal title: The AAPS Journal Authors: Salomon Stavchansky Subject(s): Medicine