Acute toxicity tests are an area of focus for developing alternative assays and approaches to address animal welfare concerns. In the context of this document, acute toxicity studies refer to studies involving a single exposure to a test chemical and include those assessing systemic toxicity as ...
This method provides information on health hazard likely to arise from a short-term exposure to solid or liquid test substance by the dermal route. This Test Guideline is intended primarily for use with rodents (rat, rabbit or guinea pig may be ...
This book covers basic aspects of different nanoparticles, including type of materials, lipid, polymeric and inorganic structures, synthesis strategies, as well as the main physicochemical characterization techniques. Moreover, this book addresses applications for both treatment and diagnosis of diseases, highlighting in vitro and in vivo findings and clinical evaluation. The chapters highlight the main barriers for drug delivery which can benefit from nanoencapsulation: the topical and oral routes. The main innovations in the field, such as gene therapy and functionalization of nanoparticles with a variety of moieties, including monoclonal antibodies for selective delivery, are discussed and illustrated with examples. Finally, the application of nanoparticles for drug delivery to cancer is reviewed considering toxicology and regulatory aspects.
A principle of the method is that in the main study only moderately toxic doses are used, and the administration of doses that are expected to be lethal should be avoided. This Guideline is intended primarily for use with rat. Groups of animals of a ...
Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".
This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of important addresses of national and international health authorities.
This open access book presents recent advances in the pure sciences that are of significance in the quest for alternatives to the use of animals in research and describes a variety of practical applications of the three key guiding principles for the more ethical use of animals in experiments – replacement, reduction, and refinement, collectively known as the 3Rs. Important examples from across the world of implementation of the 3Rs in the testing of cosmetics, chemicals, pesticides, and biologics, including vaccines, are described, with additional information on relevant regulations. The coverage also encompasses emerging approaches to alternative tests and the 3Rs. The book is based on the most informative contributions delivered at the Asian Congress 2016 on Alternatives and Animal Use in the Life Sciences. It will be of value for those working in R&D, for graduate students, and for educators in various fields, including the pharmaceutical and cosmetic sciences, pharmacology, toxicology, and animal welfare. The free, open access distribution of Alternatives to Animal Testing is enabled by the Creative Commons Attribution license in International version 4: CC BY 4.0.
Agricultural trade is a major factor determining food security in Caribbean countries. In these small open economies, exports are essential, whilst imports provide a large part of the food supply. This book examines various dimensions of trade policy and related issues and suggests policies to address trade and food security and rural development linkages. It is as a guide and reference documents for agricultural trade policy analysts, trade negotiators, policy-makers and planners in both the public and private sectors.
