Preclinical development, drug

The topic of preclinical assessment of a clinical candidate has been reviewed in Chapter 29. The topic is mentioned here because the decision as to whether it is safe to take a candidate drug into humans is ultimately a medical judgment that can only be made by individuals responsible for clinical drug development. Preclinical safety assessments are designed to provide the knowledge needed to decide whether it is reasonably safe to study a drug candidate in humans. The term reasonably safe is used in this context because that is what an FDA reviewer must answer when reviewing an IND application. 

Abernethy DR. Research challenges, new drug development, preclinical and clinical trials in the ageing population. Drug Safety 1990 5(Suppl 1/714. 

Throughout drug development, preclinical animal studies are used to predict and assure the safety of human clinical trials. The preclinical program proceeds ahead of the clinical program to provide the necessary safety/toxicity information in a timely manner. The sponsor must relate the drug product... 

Boyd MR (1997) Drug Development Preclinical Screening, Clinical Trial and Approval. In Teicher B (ed.) Cancer Drug Discovery and Development, Vol. 2, p 23. Humana Press, Totowa, NJ... 

Since drug development has turned into a systematic and rational task of optimizing molecules and their interactions with proteins, cells, and organisms, combinatorial chemistry has become a significant part of this endeavor. Combinatorial methods are mainly employed in the initial (preclinical) stages of drug development. 

E. Lipka and G. L. Amidon, Setting bioequivalence requirements for drug development based on preclinical data optimizing oral drug delivery systems, J. Controlled Release, 62, 41 (1999). 

Preclinical drug development also involves animal testing [61]. Data from one rodent species and one nonrodent species are usually collected to determine the absorption, metabolism, and toxicity characteristics of the compound. Both short-term (2 weeks to 3 months) and long-term (up to several years) studies are done. The long-term studies are particularly useful for... 

The criteria used by the CBER and CDER regulators in assessing product performance during the drug development process are similar, i.e. safety, quality and efficacy. However, the administrative details can vary in both name and content. Upon concluding preclinical trials, all... 

CNS DRUG DESIGN AND PRECLINICAL/CLINICAL DRUG DEVELOPMENT 948... 

The costs of drug development increase as a drug progresses through the development pipeline. Preclinical development is the time when chemical compounds are tested in the laboratory to learn as much as possible about how medicines work "in a test tube." These types of experiments can be done with many compounds in a relatively short time and with relatively low cost. This is also the time that animal testing begins to see whether the chemical compounds are safe. These studies help scientists to determine how medicines will be dosed in humans. They are also important to understand whether any toxicity is related to the medicines. Toxicological tests are time... 

Pravastatin study, 91 Preclinical drug development, 154 Predictive values, 106 reduced, 171-175... 

An autoimmune response is rarely detected during preclinical drug development because of the lack of good predictive animal models for the human immune system. Owing to their low incidence and idiosyncratic nature, autoimmune diseases quite often appear as a serious issue only after product launch [2,22]. 

In Situ and Ex Vivo Nasal Models for Preclinical Drug Development Studies... 

Keywords Nasal drug delivery Preclinical drug development In situ Ex vivo, Drug metabolism Drug transport... 

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