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