Safety Testing of Drug Metabolites: Mist Guidance Impact on the Practice of Industrial Drug Metabolism

[1]  M Pirmohamed,et al.  Role of drug disposition in drug hypersensitivity: a chemical, molecular, and clinical perspective. , 1998, Chemical research in toxicology.

[2]  A. Vickers.  Tissue slices for the evaluation of metabolism-based toxicity with the example of diclofenac. , 2009, Chemico-biological interactions.

[3]  Abigail Jacobs,et al.  Drug metabolites in safety testing. , 2003, Toxicology and applied pharmacology.

[4]  Albert P. Li,et al.  Metabolism Comparative Cytotoxicity Assay (MCCA) and Cytotoxic Metabolic Pathway Identification Assay (CMPIA) with cryopreserved human hepatocytes for the evaluation of metabolism-based cytotoxicity in vitro: proof-of-concept study with aflatoxin B1. , 2009, Chemico-biological interactions.

[5]  Current opinion: safety evaluation of drug metabolites in development of pharmaceuticals. , 2007, The Journal of toxicological sciences.

[6]  Vinod P. Shah,et al.  Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays , 2007 .

[7]  Jianwen Fang,et al.  Filling and mining the reactive metabolite target protein database. , 2009, Chemico-biological interactions.

[8]  Deepak Dalvie,et al.  Assessment of three human in vitro systems in the generation of major human excretory and circulating metabolites. , 2009, Chemical research in toxicology.

[9]  Karen L Davis-Bruno,et al.  A regulatory perspective on issues and approaches in characterizing human metabolites. , 2006, Chemical research in toxicology.

[10]  F. Guengerich,et al.  Safety Assessment of Stable Drug Metabolites , 2006 .

[11]  F. Sistare,et al.  Safety assessment of drug metabolites: implications of regulatory guidance and potential application of genetically engineered mouse models that express human P450s. , 2009, Chemical research in toxicology.

[12]  T. Baillie.  Approaches to the assessment of stable and chemically reactive drug metabolites in early clinical trials. , 2009, Chemical research in toxicology.

[13]  K. Pang,et al.  Safety testing of metabolites: Expectations and outcomes. , 2009, Chemico-biological interactions.

[14]  Shelby Anderson,et al.  Predicting circulating human metabolites: how good are we? , 2009, Chemical research in toxicology.

[15]  Chungping Yu,et al.  A rapid method for quantitatively estimating metabolites in human plasma in the absence of synthetic standards using a combination of liquid chromatography/mass spectrometry and radiometric detection. , 2007, Rapid communications in mass spectrometry : RCM.

[16]  J. Collins,et al.  A Regulatory and Industrial Perspective of the Use of Carbon-14 and Tritium Isotopes in Human ADME Studies , 1994, Pharmaceutical Research.

[17]  T. Baillie,et al.  Drug metabolites in safety testing. , 2002, Toxicology and applied pharmacology.

[18]  R Scott Obach,et al.  Metabolites in safety testing (MIST): considerations of mechanisms of toxicity with dose, abundance, and duration of treatment. , 2009, Chemical research in toxicology.

[19]  C. Yeung,et al.  Qualitative Analysis of the Role of Metabolites in Inhibitory Drug‐Drug Interactions: literature evaluation based on the Metabolism and Transport Drug Interaction Database , 2009, Chemical research in toxicology.

[20]  C. Hop,et al.  Plasma-pooling methods to increase throughput for in vivo pharmacokinetic screening. , 1998, Journal of pharmaceutical sciences.

[21]  Thomayant Prueksaritanont,et al.  Complicating factors in safety testing of drug metabolites: kinetic differences between generated and preformed metabolites. , 2006, Toxicology and applied pharmacology.

[22]  R Scott Obach,et al.  Metabolites and safety: What are the concerns, and how should we address them? , 2006, Chemical research in toxicology.

[23]  R. Abbott,et al.  Conference report: European Bioanalysis Forum. , 2009, Bioanalysis.

[24]  D. Luffer-Atlas.  Unique/Major Human Metabolites: Why, How, and When to Test for Safety in Animals , 2008 .

[25]  Albert P. Li.  Overview: Evaluation of metabolism-based drug toxicity in drug development. , 2009, Chemico-biological interactions.

[26]  W Griffith Humphreys,et al.  Safety assessment of drug metabolites: Characterization of chemically stable metabolites. , 2006, Chemical research in toxicology.

[27]  L. Stevens,et al.  Biomedical accelerator mass spectrometry: recent applications in metabolism and pharmacokinetics , 2008, Expert opinion on drug metabolism & toxicology.

[28]  Mingshe Zhu,et al.  Recent advances in applications of liquid chromatography-tandem mass spectrometry to the analysis of reactive drug metabolites. , 2009, Chemico-biological interactions.

[29]  A. Atrakchi.  Interpretation and considerations on the safety evaluation of human drug metabolites. , 2009, Chemical research in toxicology.

[30]  Philip Timmerman,et al.  Which human metabolites have we MIST? Retrospective analysis, practical aspects, and perspectives for metabolite identification and quantification in pharmaceutical development. , 2009, Chemical research in toxicology.

[31]  Dominic P. Williams,et al.  Clearing the MIST (metabolites in safety testing) of time: The impact of duration of administration on drug metabolite toxicity. , 2009, Chemico-biological interactions.

[32]  R Scott Obach,et al.  SEEING THROUGH THE MIST: ABUNDANCE VERSUS PERCENTAGE. COMMENTARY ON METABOLITES IN SAFETY TESTING , 2005, Drug Metabolism and Disposition.

[33]  R. Obach,et al.  What is the Objective of the Mass Balance Study? A Retrospective Analysis of Data in Animal and Human Excretion Studies Employing Radiolabeled Drugs , 2007, Drug metabolism reviews.

[34]  S. O. Mueller,et al.  Species-specific toxicity of diclofenac and troglitazone in primary human and rat hepatocytes. , 2009, Chemico-biological interactions.

[35]  Jianyao Wang,et al.  Nuclear magnetic resonance spectroscopy as a quantitative tool to determine the concentrations of biologically produced metabolites: implications in metabolites in safety testing. , 2009, Chemical research in toxicology.

[36]  F. Guengerich.  Introduction: Human metabolites in safety testing (MIST) issue. , 2009, Chemical research in toxicology.

[37]  R A Hamilton,et al.  Determination of mean valproic acid serum level by assay of a single pooled sample , 1981, Clinical pharmacology and therapeutics.

[38]  Adedayo Adedoyin,et al.  Obtaining exposures of metabolites in preclinical species through plasma pooling and quantitative NMR: addressing metabolites in safety testing (MIST) guidance without using radiolabeled compounds and chemically synthesized metabolite standards. , 2009, Chemical research in toxicology.