Now in a revised edition, Comparative Pharmacokinetics: Principles, Techniques, and Applications presents the principles and techniques of comparative and veterinary pharmacokinetics in a detailed yet practical manner. Developed as a tool for ensuring that pharmacokinetics studies are properly designed and correctly interpreted, the book provides complete coverage of the conceptual basis of pharmacokinetics as used for quantifying biological processes from the perspectives of physiology and medicine. New chapters have been added on quantitative structure permeability relationships and bioequivalence, and a number of existing chapters have been significantly revised and expanded to provide a current resource for veterinary and comparative pharmacokinetics.

The human–animal bond has evolved and diversi?ed down the ages. Dogs, cats and even horses, have long ful?lled the role of faithful companion and indeed, as exempli?ed by the introduction of seeing and hearing dogs, there may be a critical level of co-dependency between the species. In the twenty-?rst century, the animal types that are kept as pets in many parts of the world are extensive ranging from reptiles through rodents to ruminants and beyond. As would be predicted by the nature of the relationship, the approach to treatment of a companion animal is often closely aligned to that which would have been offered to their owner. However, an increasing awareness of welfare issues, such as the recognition that animals expe- ence pain and the proven bene?ts of disease prevention in intensive farming units, together with the growth in zoos and wildlife parks, has increased the likelihood of food producing and non-domesticated animals receiving medicinal products during their life-time. Although many of the individual drugs or classes of drugs administered to animals are the same as, or derived from, those given to man, the safe and effective use of drugs in animals often cannot be achieved by simply transposing knowledge of drug action on, or behaviour in, the body from one species to another. The impact of the anatomical, physiological and pathophysiological variability that spans the animal kingdom can often profoundly alter drug response.

The major objective of this handbook is to compile-in tabular form-the pharmacokinetic parameters of antimicrobial drugs used in food animals. This unique publication represents data from the FARAD (Food Animal Residue Avoidance Databank) databank, established by the authors under the auspices of the U.S.D.A. and contains significant amounts of previously unavailable information. This updated, one-of-a-kind volume even features additional data on laboratory rodents, dogs, cats, and horses in order to facilitate broader interspecies extrapolations. This easy-to-use reference is timely as well as invaluable to animal scientists, veterinarians, pharmacologists, and toxicologists who work with antimicrobials in chickens, turkeys, dairy and beef cattle, swine, goats, and sheep.

Handbook of Comparative Pharmacokinetics and Residues of Veterinary Therapeutic Drugs is a unique compilation of comparative pharmacokinetic data for veterinary therapeutic drugs. The book features an excellent introductory chapter on basic veterinary pharmacokinetics and includes pharmacological data taken from hundreds of primary research references. These data are presented in standardized units and are arranged in conveniently organized tables so that comparisons between data can be made easily. Much of the data is new and was taken from articles in which data was not subjected to pharmacokinetic analysis.

New developments in testosterone therapy are summarized here by internationally renowned experts. They review both basic and clinical knowledge in fourteen chapters. The book begins with the biochemistry of testosterone, its biosynthesis, metabolism and mechanisms of action in target organs. Three chapters deal with specific aspects of testosterone action, namely its role in spermatogenesis, its psychotropic effects and its effects on bones. Syndromes caused by androgen resistance are described in order to highlight the importance of properly functioning enzymes and receptors in the target organs. Causes and symptoms of male hypogonadism, the major indication for testosterone treatment, are described. Five chapters are devoted to the pharmacology, pharmacokinetics and clinical uses and abuses of testosterone preparations. The new transdermal testosterone application is described in detail. Side effects of testosterone treatment are reviewed. The possible role of androgens in the development of prostatic hypertrophy and carcinoma is discussed extensively since this question is of major concern to the clinician.

The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.

The definitive advanced-level clinical pharmacokinetics text is now in its Fourth Edition, with new emphasis on the relationship between pharmacokinetics and pharmacodynamics. Written by 70 leading researchers and practitioners, this book is a rigorous yet practical text on the application of pharmacokinetic methods, pharmacodynamic principles, and pharmacotherapeutic data for optimal, individualized drug therapy. This edition includes case studies that apply concepts to actual patient problems. New chapters cover tacrolimus, mycophenolic acid, sirolimus, antipsychotics, and critical evaluation of therapeutic drug monitoring methods. Other new features include more drawings and reference tables and an appendix on outcome studies with therapeutic drug monitoring.

The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.

Drug Disposition and Pharmacokinetics The most up-to-date edition of a leading reference in drug disposition and pharmacokinetics In this new, fully-revised edition of Drug Disposition and Pharmacokinetics: Principles and Applications for Medicine, Toxicology and Biotechnology the authors deliver an authoritative and comprehensive discussion of the fate of drug molecules in the body, as well as its implications for pharmacological and clinical effects. The text offers a unique and balanced approach that combines discussion of the specific physical and biological factors affecting the absorption, distribution, metabolism, and excretion of drugs, with mathematical assessments of plasma and body fluid concentrations. The book assumes little prior knowledge and is an ideal reference for practicing professionals in industry as well as researchers and academics. This latest edition provides readers with a new introductory chapter, as well as new chapters covering monoclonal antibodies, the role of stereochemistry in drug disposition and pharmacokinetics, DMPK in non-human species, and the recent use of AI in drug development. Readers will also find: Thorough introductions to drug disposition, pharmacokinetics, and pharmacokinetic modeling In-depth treatments of the kinetics of drug elimination and the relationship between concentration and effect, including PK–PD modeling Comprehensive discussions of predictive pharmacokinetics and the disposition of biological molecules, including peptides and monoclonal antibodies Detailed examinations of the effects of sex, pregnancy, age, and disease, as well as drug monitoring in therapeutics and the use of AI in drug development and treatment Perfect for professionals and researchers working with the scientific aspects of drug disposition in human and veterinary medicine, toxicology, and pharmacology. Drug Disposition and Pharmacokinetics will earn a place in the libraries of students of senior-level courses in pharmacy.