Читать книгу Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations - Sheila Annie Peters - Страница 10

PREFACE TO THE SECOND EDITION

I am excited to bring out this much improved second edition, encouraged by the success of the first edition of “Physiologically‐Based Pharmacokinetic (PBPK) Modeling and Simulations: Principles, Methods, and Applications in the Pharmaceutical Industry”. The applications of PBPK modeling and simulations have exponentially grown since the publication of the first edition of the book in 2012. Since that time, a surge in PBPK regulatory submissions has prompted the regulatory agencies to release guidelines for the reporting of PBPK modeling results that accompany submissions.

The adverse impact of the COVID‐19 pandemic on global economies is still being evaluated. Pharma companies have had their fair share of losses too. Clinical studies for various indications have been affected by stretched healthcare infrastructure, recruitment challenges, lockdown, logistics issues, and confounding disease influence on outcomes. Along with World Health Organization's SOLIDARITY trial and Institut national de la santé et de la recherche médicale (INSERM)'s Discovery trial, nearly thousand clinical studies related to COVID‐19 have been registered worldwide in the first half of 2020. In a race against time to bring innovative medicines to the market, a heightened need for Model‐Informed Drug Development (MIDD) and the totality of evidence it advocates has become apparent. The applications of PBPK modeling, an important component of MIDD, supporting dose optimization and assessment of benefit‐risk ratios have been further catalyzed by the pandemic.

The book is intended to serve the interests of a broad and diverse audience from academia, industry, and regulatory agencies. Similar to the first edition of the book, this second edition has a section that covers the principles underlying pharmacokinetics, drug interactions, and physiological modeling of pharmacokinetic processes as well as interindividual variability for small molecule drugs and biologics. The second part exposes the reader to the powerful applications of PBPK modeling along the value chain in drug discovery and development. To facilitate potential use of the book in courses or workshops, a new third section providing case studies in the different areas of application of PBPK modeling has been introduced in this edition at the request of readers and reviewers. Most of these case studies are built using PK‐Sim®, a comprehensive software tool within the Open Systems Pharmacology Suite for the physiologically based pharmacokinetic modeling of small and large molecules.

In addition to introducing a third section to the book, this second edition simplifies complex topics and provides a balanced view of the vast potential of PBPK modeling alongside current challenges. Section‐I provides substantially revised and reordered content with updated literature in all chapters. A new chapter has been added on Nonclinical, Clinical and Model Informed Drug Development. Chapters in Section‐II are entirely new and focus on the vast array of applications in the field. Two‐thirds of the figures in the second edition are either revised or new.

I hope that the inclusion of recent advances in PBPK modeling and the revisions made in the current edition will serve to benefit and engage the readers.