New drug discovery (IPF preclinical testing)

 

New drugs begin in the laboratory with scientists, including chemists and pharmacologists, who identify cellular and genetic factors that play a role in specific diseases. They search for chemical and biological substances that target these biological markers and are likely to have drug-like effects. Out of every 5,000 new compounds identified during the discovery process, only five are considered safe for testing in human volunteers after preclinical evaluations. After three to six years of further clinical testing in patients, only one of these compounds is ultimately approved as a marketed drug for treatment. The following sequence of research activities begins the process that results in development of new medicines:

  • Target Identification. Drugs usually act on either cellular or genetic chemicals in the body, known as targets, which are believed to be associated with disease. Scientists use a variety of techniques to identify and isolate individual targets to learn more about their functions and how they influence disease. Compounds are then identified that have various interactions with the drug targets that might be helpful in treatment of a specific disease.
  • Target Prioritization/Validation. To select targets most likely to be useful in the development of new treatments for disease, researchers analyze and compare each drug target to others based on their association with a specific disease and their ability to regulate biological and chemical compounds in the body. Tests are conducted to confirm that interactions with the drug target are associated with a desired change in the behavior of diseased cells. Research scientists can then identify compounds that have an effect on the target selected.
  • Lead Identification. A lead compound or substance is one that is believed to have potential to treat disease. Laboratory scientists can compare known substances with new compounds to determine their likelihood of success. Leads are sometimes developed as collections, or libraries, of individual molecules that possess properties needed in a new drug. Testing is then done on each of these molecules to confirm its effect on the drug target.
  • Lead Optimization. Lead optimization compares the properties of various lead compounds and provides information to help biopharmaceutical companies select the compound or compounds with the greatest potential to be developed into safe and effective medicines. Often during this same stage of development, lead prioritization studies are conducted in living organisms (in vivo) and in cells in the test tube (in vitro) to compare various lead compounds and how they are metabolized and affect the body.

 

  • Pre Clinical Testing for IPF Study
  • Pharmacokinetics (pK) Testing, Research and Studies
  • Genotoxicity Screening Testing
  • Pharmaceutical Half-Life Testing
  • Pharmaceutical Clearance Testing
  • Pharmaceutical Nonclinical Safety Studies (NCSS)
  • Pharmacological Profile Testing Studies
  • Pharmaceutical Acute Toxicity Testing Studies
  • Pharmaceutical Bioavailability Testing Studies
  • Pharmaceutical Bioequivalence Studies Testing
  • Pharmaceutical Metabolism Testing and Studies
  • Pharmaceutical Absorption Testing Studies
  • Pharmacological Characterization Testing Studies
  • Pharmaceutical ADME Testing Studies
  • Pharmaceutical Lead Optimization Testing Research
  • Pharmaceutical Dose Range Determination Testing
  • Pharmaceutical Pre-Clinical Efficacy Testing
  • Pharmaceutical Short-term Toxicity Studies
  • Disease Models Testing
  • Pharmaceutical Reference Testing
  • Hemodynamic Evaluation Testing
  • QT Prolongation Studies
  • Pharmaceutical Lead Identification Testing
  • Pharmaceutical Lead Optimization Testing
  • Biomarkers Research Testing
  • Pharmaceutical Radioimmunoassays (RIA) Testing
  • Immunological Testing
  • Clinical Pathology
  • Inhalation Studies Testing
  • Pharmaceutical Metabolic Stability Studies Testing
  • Pharmaceutical Metabolic Rate Studies Testing
  • Protein Binding Studies Testing
  • Preclinical Toxicology Studies
  • Product Safety Studies Testing
  • Vaccine Safety Studies Testing
  • Immunogenecity Research Testing
  • Efficacy Studies Testing
  • Interspecies Comparison Studies
  • Metabolite Identification Studies Testing
  • Pharmaceutical Chromatographic Method Research and Development
  • Pharmaceutical Absorption Studies Testing
  • In-Vivo Drug Studies Testing
  • In-Vitro Drug Screening Studies
  • In-Vitro Studies Testing
  • In-Vitro Drug-Drug Interactions Testing
  • In Vivo Pharmacokinetics Studies
  • In-Vitro ADMET Studies
  • Cytotoxicology Studies Testing
  • Neuropharmacology Studies
  • Neurotoxicity Studies
  • Drug Concentration Testing
  • Drug Sensitivity Testing
  • Drug Resistance Testing
  • Pharmaceutical Radioactivity Testing
  • Cardiac Profiling Studies
  • Pharmaceutical Infusion Studies
  • Electrophysical Testing
  • Electrophysiology Characterization Testing
  • Pharmaceutical Solubility Assay Testing
  • Permeability Assay Testing
  • In Vitro Efficacy Models Studies
  • Pharmaceutical Feasibility Studies
  • Toxicokinetic Studies Testing
  • Nephelometry Testing
  • Caco-2 Testing
  • Cytochrome P450 isozymes Induction Testing
  • Hepatocytes Testing
  • Pharmaceutical Alternate Dosing Studies
  • Pharmaceutical Single Dose Toxicity Studies
  • Pharmaceutical Repeated Dose Toxicity Studies
  • Pharmaceutical Acute Toxicity Studies
  • LC-MS/MS Testing
  • FDA Pharmaceutical CMC Testing
  • Pharmaceutical Method Development and Validation
  • Pharmaceutical Characterization Research Studies
  • Pharmaceutical Physical Properties Testing
  • Pharmaceutical Chemical Properties Testing
  • Pharmaceutical Formulation and Development Testing
  • Pharmaceutical Solid State Characterization Testing
  • Pharmaceutical Stability Studies
  • Pharmaceutical Forced Degradation Studies Testing
  • Pharmaceutical Photostability Testing
  • Pharmaceutical Identity Testing
  • Pharmaceutical Potency Testing
  • Pharmaceutical Formulation Testing
  • Pharmaceutical Preformulation Testing
  • Pharmaceutical Chemical Characterization Testing
  • Pharmaceutical Process Chemistry Research
  • Pharmaceutical Medicinal Chemistry Research
  • Pharmaceutical Custom Synthesis Research
  • Pharmaceutical Process Research
  • Pharmaceutical Process Optimization Testing