Pharmacokinetic Parameter and Statistics CalculationsĬlosely related fields in the biochemical pharmacology discipline include clinical pharmacokinetics, pharmacodymamics, pharmacology, and toxicokinetics.Dose Administration Routes and Regimens.Preclinical Toxicology and Toxicokinetics.Pharmacokinetics (PK) is the analysis and description of the disposition of a drug in the body, encompassing development of the mathematical description of all dispositional processes in the body, defined as ADME – absorption, distribution, metabolism, and elimination. FDA Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application (1987).FDA S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (1995).EMA ICH Topic E 6 (R1) Guideline For Good Clinical Practice Step 5 (2002).FDA Nonclinical Safety Evaluation of Drug or Biologic Combinations (2006).FDA M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (2010).EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples (2012).FDA Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (2013).EMA Guideline For Good Clinical Practice E6(R2) Step 2B (2015).EMA Guideline For Good Clinical Practice E6(R2) Step 5 (2016).FDA S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling (2018).Learning Center Importance Of Bioavailability And Bioequivalence In Drug Development.Learning Center Complete Guide On IND Enabling GLP Toxicology Studies.Learning Center Drug Discovery and Development Process.
NorthEast BioLab Appoints VP of Business and Corporate Development.NorthEast BioLab Announces Facility Expansion.NorthEast BioLab Launches Strategic Investment Program for Preclinical-Stage Biotech Aimed at Accelerating Innovation.Clinical Trial Sample Management and Storage.Bioequivalence and Bioavailability Studies.Drug Metabolism and Pharmacokinetics (DMPK).Method Development, Validation, and Transfer.Liquid Chromatography Mass Spectrometry.
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