Preclinical research and development

The principal issue in the drug discovery process is the high failure rate in the clinical trials, mainly due to liabilities related to poor pharmacokinetics (PK), poor efficacy, and high toxicity. The earlier lead optimization (LO) phase then represents a crucial step in the drug discovery process, since it involves the preparation and the selection of suitable drug candidates. In view of the increasing need for speed in the preclinical research and development, the determination of activity and selectivity is performed simultaneously with the evaluation of pharmacokinetic and toxicity properties. This multiparametric approach allows the early selection of the compounds with the best overall balanced druglike profile [1]. 

Preclinical Research and Development, AllChemle Inc., Wayne, Pennsylvania, U.S.A. 

The traditional view of drug development represents the process as 4 discrete stages designated as (a) discovery, (b) preclinical research and development, (c) clinical research and development and (d) post-marketing pharmacovigi-lance [1],... 

The preclinical research and development starts after the discovery and the isolation of a promising compound in the laboratory. The biological activity and safety is extensively studied in the laboratory and tested on animals. This phase is usually completed in 6 years. 

Figure 1.3. A simplified illustration of the involvement, collaboration, and interrelationship of different functional areas in a preclinical research and development organization. The bullet points summarize the major developability factors examined at different stages.

Chemical Approach Employed During Preclinical Research and Development (Route A)... 

Preclinical Research and Development 3 North Dunlap Street Memphis, TN 38163 USA... 

The compound supply for development cannot be met through the isolation and purification of discodermolide from Discodermia sp. (which must be harvested using manned submersibles). Attempts to reproducibly isolate a discodermolide-producing microorganism for fermentation have not been successful to date. Therefore, all discodermolide used for late preclinical research and development activities as well as for the ongoing... 

ANDRZEJ DEKUNDY Merz Pharmaceuticals GmbH, Preclinical Research and Development, Frankfurt Am Main, Germany... 

Preclinical research and development—using biological systems, up to and including animal models, to explore the causes of diseases and the potential safety and efficacy of new therapeutic agents. 

Analytical methods are important not only in the development and manufacture of commercial biopharmaceutical drugs, they also play a vital role in the whole drug development life cycle. Drug discovery and preclinical research require development and application of analytical methodologies to support identification, quantitation, and characterization of lead molecules. It is difficult to perform a comparative potency assay on lead molecules if one does not know how much of each is going into the assay or how pure the molecule is. Analytical methods are typically developed, qualified, and validated in step with the clinical... 

After working as a resident in medicine in a city hospital, he joined the Department of Pharmacology of Farbwerke Hoechst AG, Frankfurt as a pharmacologist and endocrinologist in 1958. In 1969 he was nominated as Director of the Department of Pharmacology at Hoechst, in 1977 Head of Pharma Research Experimental Medicine, in 1980 Head of Pharma Research, Preclinical Evaluation and Development, and in 1989 Head of the Decision Board on Pharmaceutical Development. At present, he is working as a Consultant for Pharmaceutical and Medical Research and Development. 

The preclinical research, clinical development, and approval times are explicitly given. 

---