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Medical Research Studies
Research Library
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PRA
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During clinical drug development there can be several situations where the use of radiolabeled medication or other compounds is required or favorable to accomplish the study objectives. Read how human ADME studies and “microdose” studies are used to assess absolute bioavailability (BA).
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PRA
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Hepatic impairment trials are generally included as part of the clinical development of a drug. Learn practical information for pharma and biotech professionals on similarities and differences between FDA and EMEA guidance on hepatic trials; categorization standards for hepatic trials; and solutions and guidance for those conducting hepatic trials.
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PRA
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Renal impairment trials are typically included as part of the clinical development of a drug. This whitepaper, based on years of experience executing renal trials, provides practical information for pharma and biotech professionals. In this whitepaper, you’ll gain knowledge of:
- Similarities and differences between FDA and EMEA guidance on renal trials.
- Recommended timing for renal ...
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CRI Lifetree, Inc
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Email: mayers.douglas@idenix.com IDX719, HCV NS5A Inhibitor, Demonstrates Pan-Genotypic Activity after 1774
Three Days of Monotherapy in Genotype 1, 2, 3 or 4 HCV-Infected Subjects
D. Mayers1, B. Vince2, J. Hill3, E. Lawitz4, W. O’Riordan5, L. Webster6, D. Gruener7, R.S. Mofsen8, A. Murillo9, E. Donovan1, J. Chen1, J.F. McCarville1, J. Z. Sullivan-Bólyai1 and X.J. Zhou1 ´
1Idenix ...
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PRA
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The Netherlands offers pharmaceutical firms a favorable environment for receiving expedited study review. Clinical studies can be rapidly initiated in The Netherlands due to Dutch government regulations for clinical research. Based on years of experience operating in the Netherlands, this whitepaper will:
- Outline the regulatory guidelines for studies in The Netherlands.
- Highlight ...
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