FDA re­vis­es 1999 draft guid­ance on pop­u­la­tion phar­ma­co­ki­net­ics

The FDA on Thurs­day re­leased re­vised draft guid­ance to help keep spon­sors in­formed on the da­ta and mod­el re­quire­ments for pop­u­la­tion phar­ma­co­ki­net­ics (PK) analy­ses sub­mit­ted as part of new drug ap­pli­ca­tions and bi­o­log­ic li­cense ap­pli­ca­tions.

Since the orig­i­nal pop­u­la­tion PK guid­ance was pub­lished in 1999, the FDA says the num­ber of ap­pli­ca­tions rel­e­vant for pop­u­la­tion PK analy­sis has in­creased and, “The so­phis­ti­ca­tion and re­li­a­bil­i­ty of pop­u­la­tion PK analy­sis meth­ods have im­proved.”

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