Drug Metabolism in Drug Design and Development Basic Concepts and Practice
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7 REGULATORY CONSIDERATIONS OF DRUG METABOLISM AND DRUG INTERACTION STUDIES XIAOXIONGWEI ANDMINGSHEZHU 7.1 INTRODUCTION Historic ...
bioanalysis in preclinical and clinical studies and for safety evaluation in vitro and in toxicological animal species. To avoid ...
TABLE 7.1 Selected ICH and the US FDA guidances relevant to drug metabolism and drug–drug interaction studies. Regulatory guidan ...
7.2.1 Toxicokinetic Studies The ICH published a guidance for toxicokinetics in 1995 entitled ‘‘the Assessment of Systemic Exposu ...
7.2.2 Use of Radiolabeled Materials The FDA regulation of the use of radiolabeled drugs in drug development was published in 21 ...
The ‘‘Metabolite in Safety Testing’’ (MIST) document was published by a committee of the Pharmaceutical Research and Manufacture ...
investigational new drug should be defined during drug development and that its interactions with other drugs should be explored ...
agencies, and academia (Bjornsson et al., 2003; Tucker et al., 2001). A detailed description of GLP can be found on the FDA guid ...
format of an NDA is described in 21 CFR 314.50 section. A summary of the application, technical sections, samples and labeling, ...
ADME studies with radiolabeled material. Comparative metabolic profiling data, especially metabolite profiles in plasma across s ...
comparative metabolite profiling. On the contrary, if the metabolism rate of a test drug in hepatocytes is relatively low, resul ...
Information obtained from metabolite profiling includes the number, relative concentrations, and structures of metabolites prese ...
Active Metabolites or Pharmacologically Active Metabolites The term refers to a metabolite that has target pharmacological activ ...
validated bioanalytical assay in selected clinical and nonclinical studies. However, metabolite monitoring in clinical and noncl ...
used for toxicological testing, (2) genotoxicity studies that consist of onein vitro assay to detect point mutations and another ...
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