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European Pharmaceutical Contractor
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The development process of new drugs is constantly being improved by defining new strategies and implementing new techniques. It is now recognised that the major causes for dropping drug candidates during development are the compound's pharmacokinetic (PK) properties or its absorption-distribution-metabolism-elimination (ADME) characteristics. The most frequently encountered problems in this respect include poor or highly variable absorption, polymorphic metabolic pathways and significant drug interactions.
Consequently, attrition rates can be increased by evaluating the PK/ADME properties of the compounds at the earliest possible stage; first in vitro, then in animals, and then in humans. Furthermore, in silico techniques are now emerging for very early prediction of ADME properties based on chemical structure and inferred physico-chemical properties. High-throughput screening, which was at one time mainly geared towards safety and efficacy predictors, is now also incorporating PK/ADME surrogate markers, such as binding to isolated transporters and metabolic enzymes.
In animals, toxicokinetics has developed as a specific discipline in order to allow full interpretation of the function of toxicology data in real exposure instead of dose. Microdosing is a technique that allows the evaluation of PK/ADME properties in man, prior to setting up the standard phase IA/B single and repeated escalating dose studies (1). Finally, the standard mass balance study in man, using radioisotopically labelled drugs is now often done much earlier in the clinical development process. This article is dedicated to discussing several aspects of these mass balance studies, such as:
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By Dr Xavier Deroubaix, Project Director of Phase I and Dr Alain Coquette, Head of the Department of Biology at SGS Biopharma, Belgium
Dr Xavier Deroubaix has worked for SGS Biopharma for 15 years; first as a Scientific Associate in charge of pharmacokinetic and biostatistical aspects of human PK studies, then as Head of Project Management of Phase I studies. In 1997, he became Head of the Clinical Pharmacology Division, covering the project management and organisation of Phase I/PK studies, bioanalysis, immunoanalysis and radioanalysis. He is now Project Director of Phase I.
Dr Alain Coquette began his career in 1985 as an Assistant at the Department of Experimental Immunology, Faculty of Medicine, Free University of Brussels, Belgium, where he obtained his PhD. In 1991, he joined the Laboratoires Simon SA as Head of the Department of Microbiology and Experimental Cellular Biology. In 1996, he joined SGS Biopharma as Head of the Department of Biology. Dr Coquette has published 48 scientific papers in the area of cellular immunology, toxicology and pharmacology, and since 1999 he has worked as a Professor at the University Notre-Dame de la Paix in Namur, Belgium.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
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