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Review Essays of Academic, Professional & Technical Books in the Humanities & Sciences


Fundamentals of Nuclear Pharmacy, 5th Edition by Gopal B. Saha (Springer-Verlag) Upon publication of the First Edition, Fundamentals of Nuclear Pharmacy emerged as the standard text and reference in nuclear medicine. Generously supplemented with charts, tables, and more than 100 illustrations, the revised Fifth Edition of this classic text has been thoroughly updated by judiciously replacing obsolete sections with new, cutting-edge material. Each chapter provides the reader with well-delineated descriptions of the subject matter from the basic atomic structure to the clinical uses of radiopharmaceuticals. Previous editions were highly acclaimed for their clarity and accuracy since Dr. Saha sets new standards for making complex theoretical concepts readily understandable for students and practitioners in nuclear pharmacy and nuclear medicine.

New to the Fifth Edition:

  • Expanded discussions on 99Mo-99mTc Generator and internal radiation dosimetry
  • Descriptions of all new clinically useful radiopharmaceuticals, including a section on PET radiopharmaceuticals
  • Extensive updates on the clinical uses of new radiopharmaceuticals
  • Up-to-date descriptions of both the FDA and NRC regulations, plus a section on European regulations
  • A chapter entirely devoted to molecular imaging
  • A section on treatment of non-Hodgkin's lymphoma

The fifth edition of this book has been prompted by its great appreciation in the nuclear medicine community and a constant demand for upgrading with all the new developments in radiopharmaceutical chemistry and clinical nu-clear medicine over the past 6 years. In the revision process, obsolete items have been replaced with new, up-to-date items.

The scope and contents of this edition are the same as those of the past editions. It serves as a textbook on nuclear chemistry and pharmacy for nuclear medicine residents and technologists as well as a reference book for many nuclear medicine physicians and radiologists.

The book has 16 chapters. At the end of each chapter, a set of questions and suggested reading materials related to the chapter are provided. As usual, Chapters 1 to 6 have only minor changes because the basic nature of the subject matter does not change over time. Some minor changes in Chapter 4 reflect the addition of newer equipment. Chapter 7 has been extensively revised by deleting clinically obsolete radiopharmaceuticals and adding new ones. A section on positron emission tomography (PET) radio-pharmaceuticals has been added in this chapter. Chapters 8 to 10 do not have any major changes except updated information, a new absorbed dose list in Table 10.2, and a new section on effective doses in Chapter 10. Chapter 11 is thoroughly revised to include all new, up-to-date U.S. Food and Drug Administration and Nuclear Regulatory Commission regulations and guidelines. A section on European Regulations has been added to the chapter. No revisions have has been made in Chapter 12. Many changes have been made in Chapter 13 by removing obsolete imaging agents and adding new ones for different organs. Currently, molecular imaging has be-come the prime topic of interest in imaging modalities, and so a new chap-ter, Chapter 14, has been added to briefly discuss the subject. The former Chapter 14 has become Chapter 15 with the addition of a new therapeutic radiopharmaceutical. Adverse reactions and iatrogenic alterations in the biodistribution of radiopharmaceuticals are presented in Chapter 16 without any change.

Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs by Rodney J. Ho, Milo Gibaldi (Wiley-Liss) defines biotechnology from the perspective of pharmaceuticals. The first section focuses on the process of transforming a biologic macromolecule into a therapeutic agent, while the second section provides a brief overview of each class of macromolecule with respect to physiological role and clinical application. Additional detail is also provided in the second section for each FDA approved, recombinantly derived biopharmaceutical for each category of macromolecule. The final section looks to the future and the new advances that will enhance our ability to develop new macromolecules into effective biopharmaceuticals. This last section discusses various drug delivery strategies while also describing gene and cell therapy strategies.

The list of biotechnology-based therapeu­tics has rapidly grown since 1982 when FDA approved the first recombinant biotech drug, insulin, for human use. The annual sales of several protein therapeutics have surpassed the billion dollar mark. With the completion of the primary DNA map for the human genome and the progress made in high-throughput technol­ogy for drug discovery, we are about to experience an explosive, never-before-seen growth in the development of therapeutic modalities. Biotechnology, the application of biologic molecules to mimic biologic processes, will play a central role in the dis­covery and development of protein- and gene-based drugs. While there are books discussing various aspects of biotechnol­ogy, there is no single, comprehensive source of information available for pharmaceutical scientists and health care professionals.

The general principles of pharmacology and pharmaceutics have helped us to understand the relationship between clinical outcomes and the physical-chemical properties of traditional drugs and dosage forms. These principles, however, often fail to accommodate the products of biotech­nology. The therapeutic application of protein-based drugs over the past 10 years has provided a much fuller understanding of the intricacies and mechanisms of protein disposition and pharmacologic actions. To fully appreciate the complexities of these macromolecules and their biologic effects, one must understand the fundamental differences in drug design, dosage formulation, and time course of dis­tribution, to target tissues between protein­based drugs and small organic molecules. New strategies have been developed to deliver protein-based drugs and more will follow.

We undertook the considerable task of creating this book because we believe established pharmaceutical scientists, as well as those in training, need to under­stand the principles underlying the discovery, development, and application of drugs of the future. An understanding and appre­ciation of these principles by health scien­tists, physicians, pharmacists, and other health care providers should allow in­formed decisions to improve the pharma­ceutical care of patients. The ability to integrate this knowledge in the clinical setting is essential, especially for the clini­cal pharmacologist and pharmacist. We also believe that a single source of comprehen­sive information about biotechnology is needed to serve the interests of a large population of professionals. This book con­siders biotechnology products from the following perspectives: (1) the integration of pharmacology and biotechnology with medical sciences, (2) the unique aspects of the applications of biologics or macromol­ecules as therapeutic agents, (3) the impact of biotechnology on modern medicine, and (4) the prospect of applying cutting-edge biotechnology and drug systems in shaping the future of medical practice.

Part I focuses on the process of taking a biologic macromolecule such as a protein found naturally in minute quantities from identification of structure and function to a therapeutic agent that can be delivered safely and effectively in a pharmaceutical dosage form to patients for a specific ther­apeutic indication. With the advancement of recombinant DNA technology and the enhancements in automation efficiency and computing power, we have more drug targets than we can exploit to produce, recombinantly or synthetically, drugs or pharmaceuticals that provide health bene­fits. Therefore it is increasingly important for drug industry decision makers, pharma­ceutical scientists, and physicians to acquire the knowledge that has been gained from the experience of transforming biologic macromolecules into drugs. The first part of the book highlights some of the key differences between the discovery and development of small molecules and biopharmaceuticals.

For readers familiar with biotechnology, biopharmaceutics, and the drug develop­ment process, and for those that focus on the application of biopharmaceuticals, Part II provides a brief overview of each class of macromolecule with respect to physiologi­cal role and clinical application. Additional detail for each FDA approved, recombinantly derived biopharmaceutical, and several other interesting therapeutic pro­teins, for each category of macromolecule is provided in monographs. These mono­graphs are organized as follows: (1) general description, (2) indications, (3) dosage form, route of administration, and dosage, (4) pharmacology and pharmaceutics (i.e.., clinical pharmacology, pharmacokinetics, disposition, and drug interactions), (5) therapeutic response, (6) role in therapy, and (7) other clinical applications. Readers seeking pharmacokinetic information and additional details on molecular character­istics of biopharmaceuticals are directed to the appendices.

Part III focuses on the future, on advances that will enhance our ability to develop new and already identified macro­molecules into safe and effective biophar­maceuticals. Using drug delivery strategies to optimize drug distribution profiles, including drug targeting by means of physical-chemical and physiological ap­proaches, as well as optimization of mol­ecular properties by sequence modification and molecular redesign are key strategies needed to improve safety and efficacy and to increase the limited bioavailability of macromolecules that often requires sys­temic or regional administration. This part also describes gene and cell therapies, strategies that are needed when traditional drug therapy is not suitable or effective.

For potent drugs that produce severe toxicity in a small population of patients but are otherwise safe and effective for the majority of patients, laboratory-based genetic tests are in development to identify the at-risk population. As our understand­ing of the relationship between phamacological responses and genetic variations grows, it is important to learn how pharmacogenetic and other factors may allow pharmacists and physicians to consider the cost and benefits of individualized drug selection and dosage regimens. With automation of analytical, robotic, and com­putational techniques, the role of proteomics and genomics in accelerating drug discovery and predicting pharmacophores and perhaps pharmacokinetic properties may allow scientist to reduce to a minimum the number of candidate molecules needed to be synthesized or cloned. Some of these efforts have allowed the chemical synthesis of active-site mimics that are similar to classic drugs.

The book concludes with a chapter on how these scientific advances are being in­tegrated by large and small biotechnology­driven and traditional drug companies to accelerate the drug discovery and develop­ment processes. The pharmaceutical indus­try is nearly universally incorporating biotech strategies as tools to accelerate the development of drug from concepts into products.

Smith and Williams’ Introduction to the Principles of Drug Design and Action edited by H. John Smith (Hardwood Academic Publishers) The second edition of Introduction to the Principles of Drug Design was published in 1988. In the intervening years considerable strides have been made in the approaches to rational drug design as the result of the flood of knowledge coming from advances made in molecular biology. This has provided a better understanding of biological systems in terms of their structural components, cellular signalling, genomic modulation etc., leading to a more informed approach to chemotherapeutic intervention in disease.

In the third edition the aims and objectives, as well as the intended reading audience, remain the same as in previous editions but all the chapters have been revised to take into account of new developments in their subject areas and three new chapters have been included. Chapter 4 dealing with Drug Chirality and its Pharmacological Consequences reviews an ongoing field of considerable importance to pharmacologists and especially industrial concerns in view of the recent requirements imposed by Regulatory Bodies regarding drug registration. Chapter 6 provides a fascinating account of the difficulties inherent in the development of a drug from the bench to the clinic and brings out the trials and tribulations encountered by the multi-disciplinary research teams involved. Chapter 10 on Neurotransmitters, Agonists and Antagonists compensates to some extent for an area neglected in previous editions, that is, the design of drugs for action on the central nervous system, and also provides an account of membrane-bound receptors perhaps overshadowed in previous editions by emphasis on enzyme and DNA related targets.

Chapter 3 on Intermolecular Forces and Molecular Modelling has required expansion and revision due to advances in the techniques relating to ligand-receptor interactions and we are indebted to Zeneca, through Dr M.T. Cox, for their generosity in meeting the considerable cost of reproducing the necessary new colour plates in the book. We also wish to thank Dr Charlie Laughton of the School of Pharmacy, Nottingham University for providing the illustration on the front cover of the book.

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