Organization Of The Book

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, recom-binantly 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 macro-molecules into safe and effective biophar-maceuticals. 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 phamaco-logical responses and genetic variations grows, it is important to learn how phar-macogenetic 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 proteo-mics 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 biotechnology-driven 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.

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