qps cro clinical trials clinical bioanalysis biomarkers drug elisa clinical research dmpk toxicology contract research lc-ms/ms translational medicine drug development preclinical trial pk assay development ria immunogenicity bioanalytical services in vivo qwba development pharmacodynamic neutralizing antibody multiplexing genotyping cell based assays anti drug antibodies in vitro pharmacogenomics rnai therapeutics monoclonal antibodies clinical trial bioequivalence adme tlm pgx late phase gene therapy transdermal research models biologics imaging bioavailability phase 1 gcp icp-ms neuropharmacology dermal preclinical research early phase clinical oncology pk studies assay early stage clinical transgenic biosimilar act biosimilars patients trials proteins marg ind first-in-man clinical pharmacology icp biosimilar nab sad mad fim ddi lc-icp/ms large molecule immunology immunobioanalysis pharmaceutical laboratories ind program management glp discovery contract research organization biotech study data phase ii-iv operations medical devices late stage clinical operations pet-studies quantitative whole-body autoradiography late phase clinical generics fda skin delivery drug metabolism respiratory drug development programs nce in vivo studies neuroscience program follow on biologics filgrastim be-study autoradiography small molecules large molecules cns pediatrics ich metabolism peptides phenotyping metabolic profiling human mass balance early stage safety pharmacology phase i candidate selection study ms ada rituximab ame protein binding biotransformation systemic delivery sensitization safety risk assessment irritation cutaneous adhesion small molecule sample analysis oglionucleotides monclonal antibodies dried blood spots analytical validation analytical method development vaccine studies pharmaceuticals pharmaceutical product development microdosing toxicity safety tests reproductive toxicology histopathology genetic toxicology generic toxicology general toxicology gene mutation assay fertility clinical pathology chromosome abberration assay biocompatibility testing aaalac rats non-transgenic neuronal tissue culture neurodegenerative diseases mode of action mice ko generation drug profiling animal immune response biotherapeutic pharmacology smoking trials respiratory trials research studies negative pressure room infection control covid-19 contamination radiotracers radioactive drugs drug efficacy metabolic reaction phenotyping mass balance vedotinantibody drug conjugates toxin maytansine linker dm1 brentuximab auristatine antibody adc biomolecules antibody drug conjugates protein biotherapeutics gene interference oligonucleotides gene therapy approvals pharmacokinetics qpcr genetics participants strategies pediatric trials somatropin epoetin alfa chmp tau protein knock out bbb amyloid beta abeta pk/pd sirnas sirna rnai rna interference gene-silencing dsrnas dsrna cell-specific population pop pk pk analysis regulations nda submission drug approval transdermal delivery systems white paper topical tdds route patch ointments lotions gels formulation foams diseases dermatology creams clinical trial site mabs mass spectrometry lba ligand binding c14 metabolite identification metabolite profiling metabolic pathways tissue distribution investigational drug route and rate of excretion radiolabel austria patient recruitment. patient studies lps challenge spirometry asthma allergy copd pulmonology poc-studies imp gmp eu annex 13 impd ib ccmo ethics committee clinical trial application ec cta trial submission early clinical research the netherlands advantages timeline regulatory animal models behavioral drug candidate drugs biologicals nbe in vitro studies batbi baseline-adjusted transferrinbound iron baseline-adjusted total iron bati be-studies fe(oh)3 ferric hydroxide hemoglobin cytochrome iron iron sucrose accurate healthy timely volunteers data first in human europe usa tissue pharmacokinetics rtpcr phosphor imaging quantitative real-time pcr micro-autoradiography brain distribution huntington’s disease radiolabeled drugs cyclodextrin niemann-pick disease microautoradiography radioactivity autoradioluminography food effect ba pd drug interaction mra diabetes elderly be thresholds third molar extraction model quantitative sensory testing qst m3 neuropathic heat investigation cold healthy volunteers ich gcp pain mechanical pressure nociceptive mri prodromal ad alzheimer's alzheimer distribution absorption excretion enzymes iodinated 125i compounds antibodies biotechnology reaction metabolic radioquantification plasma protein binding program management phase ii proof of concept lc-icp-ms gyros
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