Early Drug Development: Strategies and Routes to by Mitchell N. Cayen PDF

By Mitchell N. Cayen

ISBN-10: 0470170867

ISBN-13: 9780470170861

ISBN-10: 0470613173

ISBN-13: 9780470613177

The point of interest of early drug improvement has been the submission of an Investigational New Drug software to regulatory firms. Early Drug improvement: concepts and Routes to First-in-Human Trials courses drug improvement organisations in getting ready and filing an Investigational New Drug (IND) software. via explaining the nuts and bolts of preclinical improvement actions and their interaction in successfully deciding upon profitable scientific applicants, the publication is helping pharmaceutical scientists be sure what sorts of discovery and preclinical study experiences are wanted in an effort to aid a submission to regulatory businesses.

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Although it is important to generate competitive bids for study conduct from two or more CROs, those companies selected to submit bids should be high-quality organizations with an established positive reputation. CRO providers can be located by attending relevant scientific meetings. Sponsors should make independent inquiries about the CRO and/or to arrange for qualified personnel to visit the CRO site for a due-diligence evaluation. , whether economics has resulted in recent staff reductions or changes that may affect their operations) • Experience in specific study and/or therapeutic area • Operational efficiency and flexibility • Relations with regulatory agencies (including results of recent FDA inspections and severity of FD-483 citations, which should be requested for review) • Record keeping (including sample-handling procedures) and documentation [including standard operating procedures (SOPs)] • Management oversight of operations • Quality and efficiency of quality assurance oversight of operations and review of data (if applicable) • Quality of written documentation If overall quality, experience, and level of service are deemed to be similar, cost and other variables, such as turnaround time, should affect the selection.

The promising young field of toxicogenomics is emerging as a possible alternative to animal toxicology testing. , the effect on gene expression in hepatocytes) with the hope that this discipline can be employed to reduce the use of whole animals. The dilemma is whether such in vitro models or toxicity biomarkers can be roughly equivalent to the classically used in vivo models and whether cell-based screens can ever replace animal testing. Perhaps toxicogenomics may best be employed at the early screening stages as a predictive toxicology tool to eliminate NCEs in the discovery phase.

These guidances, designated with the prefix letter “S,” refer to nonclinical safety, but not clinical safety, and describe the short- and long-term toxicity studies for small-molecule drugs and biopharmaceutics. Included are genotoxicity tests, reproductive toxicology, immuntoxicity evaluations, and carcinogenicity studies. Also included in this category are support functions such as toxicokinetics, safety pharmacology (including QT-interval prolongation), and tissue distribution studies. 2. Quality.

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Early Drug Development: Strategies and Routes to First-in-Human Trials by Mitchell N. Cayen

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