But the cores of the book are the CP and PKPD aspects, which deal with principles of ADME and PKPD modeling for biologics and how they impact preclinical development, first‐in‐human dose selection, and clinical development. With such a wide range of topics, even an experienced scientific practitioner in this area is likely to find something new to engage them and expand their knowledge. Also, a wide variety of biologic modalities are covered in different chapters-antibody‐drug‐conjugates (ADC), bispecific antibodies, pH‐dependent antibodies, blood–brain barrier‐penetrating biologics-which will help break up the myth of a monolithic biologic modality. This helps provide an overview of these topics without delving into depth and thus turn off a casual reader. In spite of the breadth of the science covered in the book, most of the chapters that deal with subjects not many PK practitioners will be familiar with are relatively short and crisp, dealing only with the core principles. The authors have to be congratulated for their endeavor to stitch these topics together in a single book-although the organization of the chapters with these specialized non‐PK topics spread out among the more PK‐focused ones left this reader slightly confused. Chapters such as the one on immunogenicity (Chapter 11) provide a good background for the reason behind the differences in development strategy for biologics. This new book is the first to emerge with the ambitious objective of providing a “grand tour” of all things biologics ADME/PKPD/CP with an understandable focus on monoclonal antibodies (mAbs)-the dominant member of the biologics family.Īt the outset, one is impressed with the scope of the book it provides an outline of very diverse topics, starting with the basics of protein engineering and how these are used to design and manipulate the ADME properties of recombinant and synthetic proteins (Chapters 2 and 3). 1, 2 While these publications have aided better understanding of this subject within the general PKPD population, a more thorough discussion of these aspects in the context of the underlying biochemical, biological, and technological processes that influence these properties for biologics has been lacking. Reviewed by Balaji Agoram For more than a decade, clinical pharmacology (CP), absorption‐distribution metabolism, and excretion (ADME), and pharmacokinetics‐pharmacodynamics (PKPD) properties of biologics have received particular attention from experts within the field through increasing numbers of publications and the occasional book dealing with general aspects of CP or PK science.
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