Pharmacokinetics

Pharmacokinetics

Pharmacokinetics is the study of the time course of drug absorption, distribution, metabolism, and excretion. It also concerns the relationship of these processes to the intensity and time course of pharmacologic(therapeutic and toxicologic) effects of drugs and chemicals. Pharmacokinetics is a quantitative study that requires a preexisting competence in mathematics at least through calculus. It is also a biologic study and can be very useful to the biomedical scientist.
At a fundamental level, pharmacokinetics is a tool to optimize the design of biological experiments with drugs and chemicals. All biologists would benefit from some knowledge of pharmacokinetics whenever they engage in data analysis. It has become increasingly important in the design and development of new drugs and in the reassessment of old drugs. Clinical applications of pharmacokinetics have resulted in improvements in drug utilization and direct benefits to patients.


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Pharmaceutical Drug Analysis

Pharmaceutical Drug Analysis

‘Pharmaceutical Drug Analysis’ will prove to be a valuable and indispensable guide to
those working in Research & Development Laboratories, Quality Assurance Laboratories as well as Drug Testing Laboratories where either new products are being developed or routine analyses are carried out. Academicians and researchers engaged in the evaluation of pharmaceutical drug substances either in pure or dosage forms will also enormously benefit from ‘Pharmaceutical Drug Analysis’ by virtue of its ultimate goal of maintaining very high standards of quantitative analysis.
Finally, I wish to record here my special thanks to the numerous colleagues and friends who have not only extended their invaluable help by providing me with relevant sources of material but also by taking an active participation in the discussion of various chapters.
It is hoped that ‘Pharmaceutical Drug Analysis’ will soon prove to be an invaluable guide to both undergraduate and postgraduate students and to my esteemed colleagues in the teaching profession. Those working in Research & Development Laboratories, Quality Assurance Laboratories and Drug Testing laboratories will also find the book helpful in solving many of their intricate problems.


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Quality Control Methods for Medicinal Plant Materials

Quality Control Methods for Medicinal Plant Materials

World Health Organization (WHO) Guidelines


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An Introduction to Statistical Methods and Data Analysis

An Introduction to Statistical Methods and Data Analysis

An Introduction to Statistical Methods and Data Analysis, Fifth Edition, is a textbook
for advanced undergraduate and graduate students from a variety of disciplines. It is intended to prepare students to deal with solving problems encountered in research projects, decision making based on data, and general life experiences beyond the classroom and university setting. We presume students using this book have a minimal mathematical background (high school algebra) and no prior coursework in statistics. The first eleven chapters present the material typically covered in an introductory statistics course. However, we have provided case studies and examples that connect the statistics concepts to problems of a very practical nature. The remaining chapters cover regression modeling and design of experiments. We develop and illustrate the statistical techniques and thought process needed to design a research study or experiment and then analyze the data collected using an intuitive and proven four-step approach.


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Principles and Practice of Pharmaceutical Medicine

Principles and Practice of Pharmaceutical Medicine

Since the first edition of this book, pharmaceutical medicine has only become more diverse and has also become widely accepted as a recognized medical specialty, for example, with its first graduates of specialist training in the United Kingdom, to add to those of Switzerland, and Mexico. This has been accompanied by pharmaceutical medicine’s rapid progress toward specialty recognition within the European Community, and many changes in the pharmaceutical environment. So, we have taken this book further with this second edition. There are new chapters on European regulations, risk management, the Middle East, Asia and other topical subjects in pharmaceutical medicine. Those chapters that did appear in the first edition have all been brought up to date.
But this book is for all those working in pharmaceutical medicine, regardless of their degrees, titles or affiliations. Although it comprehensively covers the internationally harmonized syllabus for the Diplomas in Pharmaceutical Medicine that are awarded in Belgium, Switzerland and the United Kingdom, this book will also usefully serve those teaching other types of certificates and (usually Master’s) degrees in this field, as well as being a vade mecum for those who are not undertaking academic courses.
We would again like to thank the team at JohnWiley and Sons, Inc., Chichester (UK). Hannah Bradley got this second edition started, but then went off on a tour around the world; the editors strenuously deny that they are the reason why. Lucy Sayer and Juliet Booker have since piloted the ship to the dock-side, successfully cajoling us into getting this edition done before its second decade. Not least, we would like to thank you, the reader, for your continued support and suggestions. So here is our second edition, it is more than a simple update, and it is even less US-centric than before.

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Handbook for Good Clinical Research Practice (GCP)

Handbook for Good Clinical Research Practice (GCP)

Good Clinical Research Practice (GCP) is a process that incorporates established ethical and scientifi c quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects. Compliance with GCP provides public assurance that the rights, safety, and well-being of research subjects are protected and respected, consistent with the principles enunciated in the Declaration of Helsinki and other internationally recognized ethical guidelines, and ensures the integrity of clinical research data. The conduct of clinical research is complex and this complexity is compounded by the need to involve a number of different individuals with a variety of expertise, all of who must perform their tasks skillfully and effi ciently.
The responsibility for GCP is shared by all of the parties involved, including sponsors, investigators and site staff, contract research organizations (CROs), ethics committees, regulatory authorities and research subjects.


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