Kinetic models have often served as useful examples in develop ing the methodology for the design and analysis of experiments in volving mechanistic models. Thus, it is not surprising that these approaches have been applied quite successfully to kinetic obser vations. Nevertheless, many ideas and methods were developed indepen dently in various fields of science. More often than not, investi gators working in one area have not been aware of relevant advances in others. In order to facilitate the desirable exchange of ideas, a one-day symposium was held in Toronto in conjunction with the XIth...

When a biological drug patent expires, alternative biosimilar products are developed. Biological drugs are different in many respects from drugs based on chemically synthesized small molecules. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is complicated and difficult. This book presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and post-approval issues.