Effect Of Food On Pharmacokinetics Of Meloxicam

The primary objective of the study was to investigate the effect of food on the pharmacokinetics of MELOXICAM. Cmax, Tmax and AUC of MELOXICAM were defined as the main parameters for the assessmentof bioavailability and bioequivalence of MELOXICAM administered in fasting and fed conditions. The 90% CI for the fed/fasting MELOXICAM did not contained within the acceptance interval (80, 125) and, therefore, it can be concluded that the rate of systemic exposure to MELOXICAM does not fit the claim of bioequivalence between administration in fasting and fed conditions. 

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Basic Pharmacokinetics

This is the essential guide to the study of absorption, distribution, metabolism and elimination of drugs in the body. Pharmacokinetics and biopharmaceutics courses have been included in pharmacy curricula in the USA and Europe for several years. Pharmacokinetics is the study of absorption, distribution, metabolism and elimination of drugs in the body. Pharmacists must understand this to ensure appropriate drug regimen for patients. The scope and the intent of this textbook is to provide the reader with a basic intuitive understanding of the principles of pharmacokinetics and biopharmaceutics and how these principles, along with the equations presented in each chapter, can be applied to achieve successful drug therapy. The application of pharmacokinetics principles and equations are illustrated by providing the reader with data available in the literature. As pharmacokinetics is basically mathematical in nature, a chapter has been included to provide the reader with a basic review of the mathematical principles and graphing techniques necessary to understand pharmacokinetics. At the start of each chapter, important objectives are listed to accentuate and identify the key points of the chapter. When an important and clinically applicable equation appears in the text, a paragraph will follow explaining the significance and therapeutic applications of that equation. Additionally, this paragraph includes and explains relevant factors influencing parameters in an equation. When applicable, at the end of an important equation, a general profile illustrating the relationship between the two variables of an equation will be presented. This approach should make the subject matter much more accessible to the student. Each chapter concludes with related problem sets and problem solving exercises for the student to work through. This should enable the reader to become more adept at solving pharmacokinetic problems arising in drug therapy and understanding the applications and utility of equations in clinical pharmacokinetics and practice. As you can see from the contents, the book is organised into eighteen chapters, the first consists of mathematical principles necessary to understand pharmacokinetics and an overview of the subject matter. The remaining chapters are organised in an order which should be easy for the reader to follow. Clearance and other essential fundamental pharmacokinetic parameters are introduced early in the book as the student will need to apply these concepts in subsequent chapters. A uniform set of notation will be adopted throughout the textbook (a table of which will be at start of the book).

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Contemporary Drug Synthesis

An integrated and insightful look at successful drug synthesis in today’s drug discovery market

The pharmaceutical industry is unquestionably vibrant today, with drug synthesis making a vital contribution. Whether in the early developmental stages of identifying and optimizing a lead, or the latter stages of process development and cost-effective scale-up, the ability to design elegant and economical synthetic routes is often a major factor in the eventual viability and commercial success of a drug.

Contemporary Drug Synthesis examines how leading researchers and manufacturers have integrated chemistry, biology, pharmacokinetics, and a host of other disciplines in the creation and development of leading drugs. Authored by four of the pharmaceutical industry’s most respected scientists, this timely volume:

Focuses on the processes that resulted in high-profile drugs including Lipitor, Celebrex, Viagra, Gleevec, Nexium, Claritin, and over a dozen others Provides an in-depth introduction to each drug, followed by a detailed account of its synthesis Organizes the drugs into fourteen therapeutic areas for clarity and ease of use Process chemists provide an essential bridge between chemistry and the marketplace, creating scientifically practical drug processes while never losing sight of the commercial viability of those processes. Contemporary Drug Synthesis meets the needs of a growing community of researchers in pharmaceutical research and development, and is both a useful guide for practicing pharmaceutical scientists and an excellent text for medicinal and organic chemistry students.

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Real World Drug Discovery: A Chemist's Guide to Biotech and Pharmaceutical Research

Drug discovery increasingly requires a common understanding by researchers of the many and diverse factors that go into the making of new medicines. The scientist entering the field will immediately face important issues for which his education may not have prepared him: project teams, patent law, consultants, target product profiles, industry trends, Gantt charts, target validation, pharmacokinetics, proteomics, phenotype assays, biomarkers, and many other unfamiliar topics for which a basic understanding must somehow be obtained. Even the more experienced scientist can find it frustratingly difficult to get an overview of the many factors involved in modern drug discovery and often only after years of exploring does a whole and integrated picture emerge in the mind of the researcher.

Real World Drug Discovery: A Chemists Guide to Biotech and Pharmaceutical Research presents this kind of map of the landscape of drug discovery. In a single, readable volume it outlines processes and explains essential concepts and terms for the recent science graduate wondering what to expect in pharma or biotech, the medicinal chemist seeking a broader and more timely understanding of the industry, or the contractor or collaborator whose understanding of the commercial drug discovery process could increase the value of his contribution to it.

Key Features:

- Interviews with well-known experts in many of the fields involved, giving insightful comments from authorities on many of the sub-disciplines important to cutting edge drug discovery.

- Helpful suggestions gleaned from years of experience in biotech and pharma, which represents a repository drug discovery "lore" not previously available in any book.

- "Periodic Table of Drugs" listing current top-selling drugs arranged by target and laid out so that structural similarities and differences are plain and clear, with regular updates available at the book's website.

- Extensive use of diagrams to illustrate concepts like biotech startup models, preteomic profiling for target identification, Gantt charts for project planning, etc.

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Pharmacokinetics: Regulatory, Industrial, Academic Perspectives

Offering a unique, multidisciplinary approach, this state-of-the-art Second Edition details the rapidly changing role that clinical and non-clinical pharmacokinetics and drug metabolism play in the discovery and development of drug therapies -- emphasizing often overlooked regulatory, scientific, and economic issues.

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High-Throughput Analysis in the Pharmaceutical Industry

High throughput analysis plays a critical role in the pharmaceutical industry. The ever-shortening timelines and high costs of drug discovery and development have brought about the need for high throughput approaches to methods that are currently used in the industry. Written and edited by well-known contributors who remain active in this line of research, this book systematically describes high throughput analysis for the pharmaceutical industry, including advanced instrumentation and automated sample preparation. The text discusses various techniques, including HPLC, MALDI-MS, and LC-MS/MS methods, with an emphasis on the later stage of drug development, including pharmacokinetics.

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Pharmacokinetics, Second Edition

Bible of Pharmacokinetics

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Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics: Homogeneous and Heterogeneous Approaches

The state of the art in Biopharmaceutics, Pharmacokinetics, and Pharmacodynamics Modeling is presented in this book. It shows how advanced physical and mathematical methods can expand classical models in order to cover heterogeneous drug-biological processes and therapeutic effects in the body. The book is divided into four parts; the first deals with the fundamental principles of fractals, diffusion and nonlinear dynamics; the second with drug dissolution, release, and absorption; the third with empirical, compartmental, and stochastic pharmacokinetic models, and the fourth mainly with nonclassical aspects of pharmacodynamics. The classical models that have relevance and application to these sciences are also considered throughout. Many examples are used to illustrate the intrinsic complexity of drug administration related phenomena in the human, justifying the use of advanced modeling methods.

This timely and useful book will appeal to graduate students and researchers in pharmacology, pharmaceutical sciences, bioengineering, and physiology.

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Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

Safety aspects have become an outstanding issue in the process of drug discovery and development. Until 15 years ago, drug discovery and evaluation was a sequential process starting with the selection of the most active compound from a series of newly synthesized compounds by means of special pharmacological assays. Safety aspects were addressed by pharmacological testing of the selected compound in high doses in tests directed at indications other than the intended indication of the new compound. These tests were followed by pharmacokinetic studies, which were mainly aimed at confirming of a suitable half-life time and at oral activity. Safety aspects relied mostly on toxicity studies, which however gave information on changes of organ structure rather than on organ function. Toxicological and pharmacokinetic studies were adapted to the progress of studies in clinical pharmacology and clinical trails.

This "sequential" strategy has been abandoned for several reasons:

- Some negative effects on organ function, e.g. ventricular tachy-arrhythmia, were detected too late. On the other hand, negative findings in chronic toxicity studies in animals turned out to be irrelevant for human beings.

- New scientific approaches, e.g. combinatorial chemistry, high-throughput screening, in silico models, pharmaco-genomics and pharmaco-proteomics offered new possibilities.

- There are several examples which show that the "druggability" of compounds was considerably underestimated when the probability of success of a new project was assessed.

The success rate in the pharmaceutical industry and the introduction of new chemical entities to the market per year dropped dramatically, whereas the development time for a new compound increased, sometimes exceeding the patent protection. A change of strategy was therefore adopted, involving the following changes:

- Parallel instead of sequential involvement of the various disciplines (multidimensional compound optimization).

- The term "Safety Pharmacology" was coined. The International Conference on Harmonization (ICH) founded a Safety Pharmacology Working Group. Easily accessible and the most informative tests now have to be selected.

- Exposure of a drug to the body by pharmacokinetic studies on absorption, distribution, metabolism and excretion has to be investigated at an early stage of development and can contribute to the selection of a compound for development.

Toxicology experienced major achievements by the introduction of new methods, e.g., in silico methods, toxicogenomics and toxicoproteomics.

The book is a landmark in the continuously changing world of drugs. As such it is important reading for many groups: not only for all students of pharmacology and toxicology but also for physicians, especially those involved in clinical trials of drugs, and for pharmacists who have to know the safety requirements of drugs.

The book is absolutely essential for scientists and managers in the pharmaceutical industry who are involved in drug finding, drug development and decision making in the development process.

In particular, the book will be of use for government institutions and committees working on official guidelines for drug evaluation worldwide.

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Dose Optimization In Drug Development

This reference provides a concise overview of the key principles in dose selection and optimization and demonstrates applicability to recent successful new drug applications. Compiling key issues and current research on safety, efficacy, and clinical pharmacology, and PK-PD, this volume critically highlights the multidisciplinary nature of drug development and spans the fields of pharmacokinetics, clinical pharmacology, biostatistics, and experimental medicine.

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Ophthalmic Drug Delivery Systems, Second Edition

Extensively revised and updated, this second edition compares conventional and innovative drug delivery systems. The book covers significant ophthalmic advances and breakthroughs in gene therapy, ocular microdialysis, vitreous drug disposition modelling, and receptor/transporter targeted drug delivery. It examines procedures in pharmacokinetic/pharmacodynamic modeling for the determination of appropriate dosing regimens, covers new developments in animal modeling, and discusses current regulations governing patenting, commercial product release, and human testing. This in-depth reference lays the groundwork for overcoming constraints on the delivery of ophthalmic drugs.

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Pharmacokinetics in Drug Discovery and Development

Pharmacokinetics has evolved from its origin into a complex discipline with numerous subspecialties and applications in patient management, drug development, and regulatory issues. This expansion has made it difficult for any one individual to become a full-fledged expert in all areas. Fulfilling the need for a wide-ranging guide to the many existing subspecialties in this field, Pharmacokinetics in Drug Discovery and Development details the different areas in the field providing the ideal comprehensive, quick access text and reference. After an introduction of basic principles, the book is divided into sections that cover industrial and regulatory applications, clinical applications, and research applications. The following sections cover such topics as PK/PD approaches, clinical pharmacokinetic monitoring, population pharmacokinetics, linear systems approaches, and more. Fourteen authors, each an expert in his/her area of expertise, provide an extensive background into the subspeciality with emphasis on the section's theme. Covering the many sub-disciplines and providing pharmacokinetic concepts, terminology, and approaches, Pharmacokinetics in Drug Discovery and Development serves as a resource for professionals throughout this field.

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Pharmaceutical Technology. Controlled Drug Release, Volume 2

Extends the concepts of Volume 1 to include drug properties, design and optimization, coating and the effect of food and pharmacokinetics. This volume also reflects the growing interest in biodegradable polymers in oral and topical formulations.

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Foundations of Pharmacokinetics

This book is divided into two parts; in the first part the principles and the methods of pharmacokinetics are described in detail, while in the second the main pharmacokinetic parameters are described, giving for each of them the definition, the principal properties, and the methods of determination. An appendix contains the important mathematical instruments used in the main part of the book, namely the operational calculus and the convolution integral.

The first part begins with the definition of pharmacokinetics, then continues with the description of the experimental method as applied to the modeling of pharmacokinetic systems. The bulk of this part is the description of the first compartmental models used in the '30's, the more modern compartmental equations developed later, the integral equations and the matrix equations.

In the second part there is a careful distinction among pharmacokinetic parameters, i.e., parameters that represent a true pharmacokinetic property, model parameters, i.e., parameters that represent a property of a specific model, and incidental parameters, i.e., parameters that represent only the result of a particular experiment. Special care is taken to distinguish between the definition of a parameter, and the properties that derive from that definition; a considerable emphasis is also given to the fact that each method for the determination of a parameter is dependent on the specific model it is based on.

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