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Check out significance of Bioavailability (BA) and Bioequivalence (BE) in Clinical Research studies

Various therapeutic compounds are evaluated for bioavailability during the drug discovery process. Low bioavailability can be detrimental for a variety of reasons. Compounds having limited bioavailability may not reach therapeutic levels in systemic circulation, which may be costly or hazardous. During drug discovery, these difficulties are examined, and the molecule with the best bioavailability and therapeutic value is chosen for future development. Pharmacovigilance refers to the monitoring of drugs over patients based on their effects or adverse effects.

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Check out significance of Bioavailability (BA) and Bioequivalence (BE) in Clinical Research studies

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  1. Checkoutsignificanceof Bioavailability (BA) and Bioequivalence(BE)inClinical Research studies Theconcepts such as Bioavailability(BA)and Bioequivalence(BE)playacrucialroleindetermining the dosagelevels ofnewdrugs to theclinicaltrialparticipants.Thisisamajorpartoftheclinical research studiesasthe wholetrialprocesses arecompletelydependentonthe effectivenessof newlydeveloped drugs.Thus,theclinical researchcourseistheperfectstarting for interestedstudentstogetin-detailed conceptsof each clinical processes. Meaning: Bioavailabilityis the relativequantity ofadrugwithrespecttoanadministereddosageandtherate of dosage withintenttoenter insystemiccirculation. Drugbioavailabilityisdeterminedby measuringthe concentrations of the active ingredient (API) and its metabolites in plasma or serum. The API concentration also influencesactive componentreleasefromtherapeutic molecules,aswellas absorption,circulation,metabolism, andelimination. Whereas Bioequivalence meanswhen takenatthesame molardose, adrugproduct'sextentandrate of absorption arenotstatisticallyvery different fromthoseofthe reference product.These studiesare carriedouttoevaluatetheefficacyofanovelmedicationproductthat maycontainanumber of differentdiluents or inactivechemicals.Drugbioequivalenceisassessedby determining ifdifferent formulationsallowthe sameamount ofactivecomponentandeffectivenessinthebody. RelevanceofBA/BEstudies DrugDevelopment Varioustherapeuticcompoundsareevaluatedforbioavailabilityduringthedrugdiscoveryprocess.Low bioavailabilitycanbedetrimental foravarietyofreasons.Compoundshavinglimited bioavailabilitymay notreachtherapeuticlevelsinsystemiccirculationormay needavery largedose,whichmay becostly orhazardous. Thesechemicalsmayrequirefurtherchemical modifications toincreasebioavailability. During drug discovery, these difficulties are examined, and the molecule with the best bioavailability and therapeutic value ischosenforfuturedevelopment.The observationofdrugsover thepatients on basisoftheireffectsoradverseeffectscomesinpharmacovigilance.Furthermore,theseconceptsare focusedin detail inthe pharmacovigilancecourse. Whenitcomes tothedevelopment ofnewdrugs,itisalways a mandatory taskof clinicaltrialregulators tointroduce theregulationandprotocolsrelated to thepatientand drugsafety.Thishelpsinsteering clearofanyadverseeventsinthepossiblefuturesituations.Thus aregulatory affairscourseallows individuals tolearn aboutthein-field protocols that facilitate the safety of drugs andpatients. PreclinicalResearch Theresearchersrigorously adheretopreclinicalbioavailabilityandbioequivalencestudyrequirements, resulting insecureexecution andmeaningfuldata acquisition. After preclinicaltesting,the mostsafe and effectivemedicationcandidates arechosenforfuturedevelopment. ClinicalResearch

  2. Whenadrugcandidateenterstheclinicalphase,asuitableformulationwiththe highestbioavailability is created.Becausetheinitialresearchmustbeginwithalow doselevel,tabletsaremanufactured with onlythelowdoselevels.Higherdosagesare provided andshowntobesafeas thetrial develops.Atthis point,themedicinemustbereformulatedwithagreaterAPIcontent.Toclaimthatthesemanytablets ofthelowerdosearebioequivalenttoasingletabletofthehigherdose,theFDArequires bioequivalence studiestobecompleted. Conclusion: IncorporationofBA/BEstudiesinto clinicalresearchis detrimentalasitprovides abaseforfurther exploration in medicine.Thiscouldbemasteredbytakingupprofessionalcourses thatcoverallthe topicsofclinical researchand help studentsgainperceptiveinsights.

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