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Biopharmaceutics Modeling and Simulations
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 The aim of this book is to provide a systematic understanding of biopharmaceutical modeling. Probably, this is the first book challenging this difficult task. Biopharmaceutical modeling demands a wide range of knowledge. We need to understand the physical theories, the physiology of the gastrointestinal tract, and the meaning of drug parameters. This book covers the wide range of scientific topics required to appropriately perform and evaluate biopharmaceutical modeling. In this book, oral absorption of a drug is mainly discussed. However, the same scientific framework is applicable for other administration routes such as nasal and pulmonary administrations. Oral absorption of a drug is a complex process that consists of dissolution, precipitation, intestinal wall permeation, and gastrointestinal transit. In addition, drug metabolism can also occur in the intestinal wall and the liver before drug molecules enter into systemic circulation. Historically, a reductionist approach has been taken to understand the oral absorption of a drug. Each process of oral absorption was reduced to its subprocesses up to the molecular level. However, understanding each piece of the puzzle is insufficient in understanding the whole picture of oral absorption. It is critically important to reconstruct the whole process of oral absorption and understand the interrelationship between each piece that comprises oral absorption of a drug. In the field of biology, computational systems biology has been emerging since the millennium [1]. In systems biology, the interactions between biological molecules are investigated in both reductionist and constitutive approaches tunderstand the quantitative relationship between a disease state and each molecular process. In this book, a similar approach is applied for the oral absorption of a drug. In the first section of this book, the whole picture of oral absorption is discussed. As the central dogma of oral drug absorption, the interplay of dissolution rate, solubility, and permeability of a drug is discussed in a comprehensive manner without using mathematics. Even though the discussion in the first section is only a conceptual and qualitative outline, correct understanding of this central dogma will be of great benefit for drug discovery and development. The central dogma of oral drug absorption is the basis of the biopharmaceutical classification system (BCS), which is widely used in drug discovery and development [2]. We then move forward to each theory that comprises the entire oral absorption model. In this book, the entire mathematical framework is called the “gastrointestinal unified theoretical framework (GUT framework).” The concept of “concentration” is first discussed in detail, as it is critically important for understanding biopharmaceutical modeling. Then, theories of solubility, dissolution, precipitation, membrane permeation, and drug metabolisms are discussed. Each theory is described based on the unified definition of drug concentration and then incorporated into the GUT framework. We then move forward to the physiological and drug property data that is used for biopharmaceutical modeling. The quality of biopharmaceutical modeling heavily relies on the quality of input data. The input data are roughly categorized into drug property and physiological parameters. These data are reviewed from the viewpoint of their use in biopharmaceutical modeling. Before moving on to the discussions about practical applications of biopharmaceutical modeling in drug research, the validity of biopharmaceutical modeling is critically reviewed. A step-by-step approach has been taken to validate the biopharmaceutical modeling employing Occam’s razor as a leading principle. As the applications of biopharmaceutical modeling in drug research, biopharmaceutical classification system, dose/particle size dependency prediction, selection of solid form and enabling formulation, food effect prediction, etc. are then discussed. Next, the strategy to use biopharmaceutical modeling in drug research and regulatory application is discussed. Introduction of good simulation practice for biopharmaceutical modeling would be an emergent issue for regulatory application. Many figures and tables are provided to make it easy to understand biopharmaceutical modeling. In addition, more than 900 references are cited. I hope that readers will enjoy reading this book and that this book will be a helpful reference for biopharmaceutical modeling. I would like to thank Mr. Jonathan Rose of John Wiley & Sons, Inc. for giving me this opportunity to write a book about biopharmaceutical modeling. I would like to thank Dr. Takashi Mano and Dr. Ravi Shanker for carefully reading my manuscript and giving me valuable advice. They also supported the investigation of biopharmaceutical modeling at Pfizer. I also thank Dr. Brian Henry, Dr. Mark McAllister, and Ms. Nicola Clear for their kind support at Pfizer. The scientific discussion with the Pfizer biopharmaceutics group members improved my understanding of this subject. The suggestions from Prof. Steve Sutton, Dr. Kazuko Sagawa, and Ms. Kelly Jones about in vivo physiology are greatly appreciated. Ms. Joanne Bennett kindly lectured me about the cell culture models. I would like to thank Dr. Claudia da Costa Mathews, Dr. Hannah Pearce, Dr. Sue Mei Wong, Mr. Simon Pegg, Mr. Neil Flanagan, Mr. Mike Cram, Mr. Unai Vivanco, Ms. Sonia Patel, and Mr. Richard Manley for investigating the enabling formulations and physchem screening. I would like to thank the Pfizer Pharmaceutical Science members for supporting and inspiring me to pursue the sciences and practical drug research work. I would like to thank Dr. Tomomi Mastuura for her instructions about pharmacokinetics. I would like to thank Dr. Stefan Steyn for implementation of biopharmaceutical modeling in early drug discovery. Thanks also goes to the Pfizer Nagoya Pharm R&D members. Mr. Shohei Sugimoto, Dr. Toshiyuki Niwa, Dr. Naofumi Hashimoto, Mr. Akinori Ito, Dr. Takashi Kojima, Mr. Omura Atsushi, and Mr. Morimichi Sato kindly taught me solid-state chemistry and enabling formulations. I would like to thank Mr Arimich Okazaki, Mr. Yohei Kawabata, Ms. Keiko Kako, Dr. Sumitra Tavornvipas, Ms. Akiko Suzuki, Ms. Tomoko Matsuda, and Ms. Shiho Torii for kindly working together toward progress of the science at the Nagoya site. I would like to thank Dr. Ryusuke Takano of Chugai Pharm. for his excellent works on biopharmaceutical sciences. I also would like to thank the Chugai physicochemical and pharmacokinetics group members, especially Mr. Hirokazu Hamada, Dr. Noriyuki Takata, Dr. Akiko Koga, Mr. Ken Goshi, Dr. Kazuya Nakagomi, Mr. Ro Irisawa, Ms. Harumi Onoda, Dr. Hidetoshi Ushio, Dr. Yoshiki Hayashi, Dr. Yoshiaki Nabuchi, Dr. Minoru Machida, and Dr. Ryoichi Saito. They brought me up as an industrial scientist. I would like to thank Dr. Ken-ichi Sakai and Mr. Kouki Obata for working with me toward progress of the sciences at Chugai. I would like to thank Dr. Alex Avdeef for finding a young scientist at a rural countryside in Japan and introducing him to the world. I greatly appreciate the kind support from the UK physicochemical scientist community, especially, Dr. John Comer, Dr. Karl Box, Dr. Alan Hill, Dr. Nicola Colclough, Dr. Toni Llinas, Dr. Darren Edwards, and other scientists. Their kind support made my UK life enjoyable and fruitful. I would also like to thank Prof. Amin Rostamihochaghan, Dr. David Turner, Dr. Sibylle Neuhoff, and Dr. Jamai Masoud of SimCYP. I would like to thank Prof. Per Artursson, Dr. Manfred Kansy, Dr. Bernard Faller, Dr. Edward Kerns, and Dr. Li Di for discussions about PAMPA. I would like to thank Dr. Lennart Lindfors for constructive discussions. I greatly appreciate the mentorship of Prof. Katsuhide Terada and Prof. Shinji Yamashita. I also would like to thank Dr. Makoto Kataoka and Dr. Yoshie Masaoka for the collaboration works. Finally, I would like to express my greatest thanks to my wife, Hitomi.Without her dedicated support, I could not have gone through the tough task of writing a book like this. I sincerely dedicate this book to her. Kiyo Sugano |
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