How Do I Get My Compound Into Phase I?
How Do I Get My Compound Into Phase I?

The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert

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    A large pharmaceutical company with globally distributed preclinical R&D operations including externalized services implemented an advanced assay/ study tracking and optimization system in conjunction with its enterprise electronic lab notebook.

  • Brochure: Norwich Clinical Services

    Norwich Clinical Services is a contract research organization that provides Bioanalytical Services, Pharmacovigilance and Clinical Research Programs to the pharmaceutical and biotech industries.

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  • White Paper: Foreign Clinical Trial Data Given the high cost of moving a promising drug candidate through years of clinical trials, it’s no wonder that more and more drug manufacturers have begun conducting at least some of their clinical trials in foreign countries. With lower costs and shorter recruiting times, the use of foreign sites is appealing to all drug developers, but especially to those involved in generic and “fast-track” approval programs.
  • White Paper: Understanding the 505(b)(2) Approval Pathway 505(b)(2) is a new drug application which gains approval for new drugs in a fraction of the time and cost required by traditional paths.
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