Laszlo Endrenyi - Böcker

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development 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 pre- and post-approval issues.

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 International Congress of Biochemistry. Biochemists, pharmacolo­ gists,> and statisticians came together and discussed many of the topics presented in this volume. Participants in the symposium believed that it would be use­ ful to publish a collection of the presentations together with some additional material. The present volume is the result. It is an attempt to convey some of the interdisciplinary concerns involv­ ing mechanistic, and especially kinetic, model building. The coverage is by no means exhaustive: many principles, methods, and problems are not included. Even the applications are limited to biochemistry and pharmacology. Still, the symposium highlighted areas of current interest. These included questions of weighting, robust parameter estimation, pooled data analysis, model identification, and the design of experiments. These topics, which are of interest in many fields of science, are discus3ed also in the present volume.