Download presentation
1 -

A human absorption metabolism and excretion hAME study is conducted to


disposition in the body and to characterize its metabolitesWhen it comes to radiolabeled hAME studies Frontage is your one-stop-shop The combination of our in-house clinical and DMPK experts provides

sophia/ sophie's Recent Documents

Decline testing orto provide recordsRequired to selfisolate for 14 da
Decline testing orto provide recordsRequired to selfisolate for 14 da

Fully vaccinatedPartially vaccinatedUnvaccinatedNone8 DaysDay 8 negative test8-day self-isolation notest required unlesssymptomaticVaccinationStatus of TravellerSelf-IsolationRequirementsTestingRequir

published 0K
TheBasicsofGraphicalModelsDavidMBleiColumbiaUniversitySeptember3020161
TheBasicsofGraphicalModelsDavidMBleiColumbiaUniversitySeptember3020161

Graphicalmodelsprovideamoreeconomicrepresentationofthejointdistribu-tionbytakingadvantageoflocalrelationshipsbetweenrandomvariables2DirectedgraphicalmodelsAdirectedgraphicalmodelisadirectedacyclicgrap

published 0K
IN THE SUPREME COURT OF FLORIDAPRENTICE STANLEYPetitionerCASE NO SC11D
IN THE SUPREME COURT OF FLORIDAPRENTICE STANLEYPetitionerCASE NO SC11D

PETITIONERS BRIEF ON JURISDICTIONON PETITION FOR DISCRETIONARY REVIEW FROM THE FOURTH DISTRICT COURT OF APPEAL OF FLORIDACAREY HAUGHWOUTPublic DefenderFifteenth Judicial Circuit of FloridaAnthony Calv

published 0K
Never immerse the motor base in water Empty the jug and fill it with w
Never immerse the motor base in water Empty the jug and fill it with w

MW 62200IM indd 62012/07/11 125211 PMMW 62200IM indd 52012/07/11 125211 PMMW 62200IM indd 42012/07/11 125211 PMTo eliminate a choking hazard for young with care 150 remember the blades are

published 1K
Deprivation
Deprivation

of LibertySafeguardsDoLSFactsheet 483LPMay 2021part of the Mental Capacity Act 2005 which applies in England and Wales The DoLS procedure protects a person receiving care whose liberty has been limite

published 0K
MemorandumofUnderstanding between the Consumer FinancialProtection Bur
MemorandumofUnderstanding between the Consumer FinancialProtection Bur

during these Chief Data MOU All activities undertaken in connection with this MOU are subject to the availability of personnel resources and funds F Third Parties Nothing in this MOU creates or afford

published 0K
RECRUITMENTAPM  520Employment of Near RelativesRev 10109Page 1The e
RECRUITMENTAPM 520Employment of Near RelativesRev 10109Page 1The e

RECRUITMENTAPM - 520Employment of Near RelativesRev 6/3/85Page 2520-16RestrictionA member of the University staff shall not participate in the processes of reviewand decision-making on any matter conc

published 0K
In This Issue
In This Issue

1page 12009 Post-Convention NewsPresident146s MessageRaymond A Bologna MDpage 2President146s MessagePresident-Elect146s ReportIndustry OpportunitiesTreasurer146s ReportSecretary146s ReportOSMA Reportp

published 0K
Download Section

Download - The PPT/PDF document "" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.






Document on Subject : "A human absorption metabolism and excretion hAME study is conducted to"— Transcript:

1 A human absorption, metabolism and excre
A human absorption, metabolism and excretion (hAME) study is conducted to identify compound disposition in the body, and to characterize its metabolites. When it comes to radiolabeled hAME studies, Frontage is your one-stop-shop. The combination of our in-house clinical and DMPK experts provides our clients full support, with a comprehensive approachAfromA�n�t�alAplann�ngAforAthe�rAhAbEAstudyAthroughA�nalAstudyAreportIA Full Service Radiolabeled hAME Studies to Support your Drug Development Programs 2 Frontage Clinical Services Approach: Purpose built clinical facility with a dedicated unit to conduct hAME studies. Expert hAME study protocol development/review, along with data management and biometrics support services. Rapid recruitment from a large database of healthy volunteer subjects, and study conduct by highly skilled and experienced research team. Dedicated, restricted access ward to accommodate up to 8 subjects in our 160-bed Phase 1 unit. •On-sitecompoundingpharmacyfordoseprepara�on. •Experiencednuclearpharmacisttopreparedosesonsitefororalorinjec�onadministra�on. •Collec�onandprocessingofsubjectbloodandexcreta. •Seamlessintegra�onwithFrontageDMPKforsampleanalysisandreal-�meradioac�vitycoun�ng thatallowsfor

2 40069;melysubjectrelease. Frontage Colla
40069;melysubjectrelease. Frontage Collaborates With Clients To Design Studies That: •Determinethepharmacokine�cs,routesofelimina�onandclearanceofpoten�altherapeu�c agent. •Iden�fymetabolitesinvariousbiologicalmatricesusinghighresolu�onmassspectrometry,other analy�caltechniquessuchashigh�eldNMR,andbycomparisonwithsynthe�cstandards. •Obtaintherela�veexposureofmajormetabolitesandcon�rmadequatecoverageinpreclinical toxicology species. •Maximizecumula�verecoveryoftotalradioac�vityinexcreta(massbalance). Frontage Labs Highly Experienced DMPK Team Approach: •FollowingQWBA,radia�ondosimetryreportthatisbasedoncurrentregulatoryrecommenda�ons is provided prior to hAME study conduct. •detailedanaly�calprotocolisprovidedfortheanalysisofsamplestosupportthehAMEstudy. •Dailyrepor�ngofmassbalancedatatodemonstraterecoveryandexcre�onpathwaysofadministered radioac�vity.Furthermore,dailymassbalancedatatoensurethe�melyreleaseofsubjectswhomeet the discharge criteria. •DMPK-to-Clinicaltransi�onofinforma�onwithinFrontagefostersminimaldelaysinrepor�ngdata andenhances�melinee�ciencies. •Metaboliteiden��ca�o

3 n,characteriza�onandpro
n,characteriza�onandpro�lingofsamplesbyindustry’sleadingexperts equippedwiththestate-of-the-artinstrumenta�on. 3 Metabolite Profiling Recovery of the Administered Radioactivity uFusBIEvlFalCovlrKF(NFoDFAosl)cEFlF(oour) oFal FBcBs AECDB QWBA with MCID Analysis 4 Final Deliverables: ICHE3-formatted Clinical Study Report with pharmacokinetic, metabolite characterization and mass balance data, and CDISC-compliant datasets and e-submission documents. The Frontage Difference: Experience the benefits and added value of Frontage’s complete suite of clinical and analytical services for hAME studies - seamless conduct and precise analysis by the most client-focused experts in the industry. C-Drug ReceiptRat Tissue Distribution (QWBA)Final Recovery ReportFinal PK and Metabolite ID ReportFinal Clinical Study ReportProtocol ReviewFinal Dosimetry ReportContract Award / Protocol Concept SheetFinal Protocol / ICF / IRB SubmissionSample Analysis PlanDatabase LockDraft PK and Metabolite ID ReportFirst Subject DosedLast Subject CompleteDaily Recovery Analysis 6.5 mos2 mos 3 mos3 mos 1 mo4 mos hAME Study Timeline Frontage Laboratories, Inc. is a contract research organization (CRO) that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goal

4 s. Comprehensive services include drug m
s. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China, and other countries. FOR MORE INFORMATION, CONTACT US AT : sales @ frontagelab.com OR VISIT US AT: frontagelab.com Frontage Laboratories, Inc. Headquarters, Bioanalytical and DMPK Services 700 Pennsylvania Drive Exton, PA 19341 P: ( 610 ) 232 - 0100 FAX: ( 610 ) 232 - 0101 Frontage Clinical Services, Inc. Clinical Research Center 200 Meadowlands Parkway Secaucus, NJ 07094 To participate in a clinical study: 1.877.298.9071 TOLL - FREE: 1.888.227.9499 FAX: 201.552.2597 Frontage hAME Team •Expertsta�withanaverageof25years’experienceinQWBA,dosimetry,hAME,andearlyphase clinical studies. •QAsta�tosupportallaspectsofhAMEstudies. •science-driventeamofscien�ststoprovidescien��cinputanddeliverhighqualitydatain �melymanner. •Provenhistoryof�exibility,focusoncommunica�on,andsuccessfulexecu�onofallpre-clinical and clinical studie