Preclinical studies, enabling

In development the same types of major questions always remain to be answered in appropriate preclinical studies, even if the nature of those experiments has changed as greater understanding and more searching techniques have enabled more precise or more specific questions to be asked. This generalization can be illustrated by the history of the industrial production of interferon and antilymphocyte antibody. 

This section mainly addresses the purpose and technical aspects of preclinical studies which are described and recommended in the registration guidelines of the EEC, Japan and the USA. The following brief descriptions of commonly used test procedures cannot replace the detailed study of guidelines by those who conduct these trials. They are intended to give the less experienced an idea about the safety standards, which have to be fulfilled by a medicinal product and about the purpose and conduct of these tests. This enables scientists in research and development to judge essential parts of a project for themselves and to make better and informed decisions. It also assists in planning time and cost of a project. 

Clinicians and regulators need to be reassured that information concerning all of these different aspects is available to enable clinical trials to progress and ultimately to support regulatory decisions on whether a new drug can be approved for marketing. Preclinical studies of potential... 

It is possible that some researchers will want to use an assay kit for a different species than the kit is intended to be used for. This is most likely to occur if a human diagnostic assay is used to measure animal samples. In drug development, all new chemical entities (NCEs) will be evaluated in preclinical studies, so relevant assays are required to support these studies, that is, TK/PK and PD analysis. There can be advantages of using the same analytical method across different species, for example, to enable comparability of data. 

Most successful PEG-anticancer prodrugs in preclinical studies have been probably PEG conjugates with taxanes camp-tothecin (CPT) (Prothecan ) and paclitaxel (PCL) ° ° which have been approved by FDA for clinical studies. This approval was based on detailed study of conjugation reactions of taxanes with PEG and study of optimal spacers enabling controlled drug release including the benzyl elimination and trimethyl lock... 

The gold rush in clinical trials has to stop, and prospective randomized clinical trials with a central data registry must be conducted, Only if current standards for clinical trials are met, will cell therapy be taken seriously by a large, and of course, skeptical community. Creating a consensus for preclinical and clinical data standards and conducting the studies would enable... 

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