b'THE ALTASCIENTISTOur most recent issues of The Altascientist tackle popular subjects in both preclinical and clinical research, including a case study.Challenges and KeyPlanning Your Preclinical Considerations in FIH Trials Assessment for a Successful First-in-human(FIH)trialsintheInvestigational New Drug (IND) earlyphasesofdrugdevelopmentApplication representacriticalmilestoneintheThere are many challenges associated approvalofmedicines,allowingwithearlydrugdiscoveryand sponsors to determine potential risksdevelopment. With timelines, budget associated to the drug at each stepand market competition being critical of its development and determine thefactors, advancing your best candidate safe dose range in the course of itsforregulatorysubmissionsrequires clinical progression. a careful assessment of efficacy and In this issue, we discuss: toxicity prior to entering human trials.Key aspects in successful FIH studyIn this issue, we discuss:designs Preparing an IND submission The importance of checklistaccess to patient Preclinical programpopulations considerations,Integrating adaptive including FAQsdesigns in FIH trialsEstimating timelinesBenefits of working Selecting the rightwith a CRO with CRO for yourexpertise in both programpreclinical andclinical researchA case studyREQUEST YOUR COPY REQUEST YOUR COPYView all previous issues of The Altascientist '