b'CHALLENGES IN EARLY PHASECLINICAL PHARMACOLOGY STUDIES:A FOCUS ON CNS AGENTSTherearemanychallengesassociatedwithearlyphasedrug development as you work towards successful NDA submission, and a good CRO partner takes pride in helping you overcome them in the most efficient, seamless manner possible. Drugs that are centrally active (the parent drug or metabolite[s]) may require additional evaluations tocharacterizethedrugeffectsanduniquesafetycharacteristics related to abuse potential, physical dependency, driving impairment, etc.Notallcentrallyactingdrugsrequireadditionalassessments; however, strategic direction early in a drug development program can help determine if such studies may be needed, or waived. Letsdiveintothechallengeofhavingsufficientandappropriate data on hand for your end of Phase II (EOP2A) meeting with the FDA, when working on an NDA for a CNS-active drug.'