Non-Biological Complex Drugs: The Science and the Regulatory Landscape (AAPS Advances in the Pharmaceutical Sciences Series Book 20)

The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates the challenges associated with NBCD development, as well as the complexity of assessing the effects of manufacturing changes on innovator and follow-on batches of NBCDs. It also touches upon proven marketing authorization requirements for biosimilars that could be effective in evaluating follow-on NBCDs, including a demonstration of control over the manufacturing process and a need for detailed physico-chemical characterization and (pre)clinical tests. This book is meant to be used for years to come as a standard reference work for the development of NBCDs. Moreover, this book aims to stimulate discussions and further our thinking to ensure that decisions regarding the approval of complex drugs are made with relevant scientific data on the table. Front Matter....Pages i-ix Introduction: Defining the Position of Non-Biological Complex Drugs....Pages 1-8 Front Matter....Pages 9-9 Polymeric Micelles....Pages 11-76 Liposomes: The Science and the Regulatory Landscape....Pages 77-106 Glatiramoids....Pages 107-148 Iron Carbohydrate Complexes: Characteristics and Regulatory Challenges....Pages 149-170 Drug Nanocrystals....Pages 171-189 Front Matter....Pages 191-191 Analytical Methods for Determining the Size (Distribution) in Parenteral Dispersions....Pages 193-259 NBCD Pharmacokinetics and Bioanalytical Methods to Measure Drug Release....Pages 261-287 Front Matter....Pages 289-289 Low Molecular Weight Heparins, Biological Drugs close to Non-Biological Complex Drugs....Pages 291-331 Nanoparticle Albumin-Bound Anticancer Agents....Pages 335-354 Front Matter....Pages 353-353 The EU Regulatory Landscape of Non-Biological Complex Drugs....Pages 357-380 Epilogue: What Did We Learn? What Can We Expect in the Future? Concluding Remarks and Outstanding Issues....Pages 381-388 Back Matter....Pages 389-390