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renal function. European Agency for the Evaluation of Medical Products. EMA (2004b) Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population. European Agency for the Evaluation of Medical Products. EMA (2005). Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function. European Agency for the Evaluation of Medical Products. EMA (2008) Note for Guidance on Non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (CPMP/ICH/286/95). EMA (2011) Guideline on Bioanalytical Method Validation. European Agency for the Evaluation of Medical Products. EMA (2012) Guideline on Investigation of Drug Interactions. European Agency for the Evaluation of Medical Products. Falcão, A., et al. (2007) Effect of Gender on the Pharmacokinetics of Eslicarbazepine Acetate (BIA 2-093), a New Voltage-gated Sodium Channel Blocker. Biopharmaceutics and Drug Disposition, 28(5), 249-256. FDA (2000) Guidance for Industry, Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. U.S. Department of Health and Human Services. FDA (2001) Guidance for Industry, Bioanalytical Method Validation. U.S. Department of Health and Human Services. FDA (2003) Guidance for Industry, Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations. U.S. Department of Health and Human Services. FDA (2006) Guidance for Industry, Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling. U.S. Department of Health and Human Services. FDA (2008a) Guidance for Industry, CGMP for Phase I investigational drugs. U.S. Department of Health and Human Services. FDA (2008b) Guidance for Industry: Safety Testing of Drug Metabolites. U.S. Department of Health and Human Services. FDA (2012) Guidance for Industry: Drug Interaction Studies – Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations. U.S. Department of Health and Human Services. Fekete, S., Kohler, I., Rudaz, S., Guillarme, D., (2014) Importance of instrumentation for fast liquid chromatography in pharmaceutical analysis. Journal of Pharmaceutical and Biomedical Analysis, 87, 105-119. Frederick, C.B., Obach, R.S. (2010) Metabolites in Safety Testing: “MIST” for the Clinical Pharmacologist. Clinical Pharmacology & Therapeutics, 87(3), 345-350. Fortuna, A., Alves, G., Falcão, A., Soares-da-Silva, P., (2012) Evaluation of the permeability and P- glycoprotein efflux of carbamazepine and several derivatives across mouse small intestine by the Using chamber technique. Epilepsia, 53(3), 529-538. Fortuna, A., Alves, G., Soares-da-Silva, P., Falcão, A., (2012) Pharmacokinetics, brain distribution and plasma protein binding of carbamazepine and nine derivatives: New set of data for predictive in silico ADME models. Epilepsy Research, 107(1-2): 37-50.
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Biomedical Chemistry: Current Trends and Developments
Title
Biomedical Chemistry: Current Trends and Developments
Author
Nuno Vale
Publisher
De Gruyter Open Ltd
Date
2016
Language
English
License
CC BY-NC-ND 4.0
ISBN
978-3-11-046887-8
Size
21.0 x 29.7 cm
Pages
427
Keywords
Physical Sciences, Engineering and Technology, Chemistry, Organic Chemistry, Green Chemistry
Categories
Naturwissenschaften Chemie
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Biomedical Chemistry: Current Trends and Developments