Plan­ning a clin­i­cal sup­ply pro­gram? Don’t over­look pri­ma­ry pack­ag­ing.

Im­age cour­tesy of Catal­ent Phar­ma So­lu­tions © 2017 Catal­ent, Inc. All rights re­served



When plan­ning a clin­i­cal tri­al, pri­ma­ry pack­ag­ing — the ma­te­ri­als that come in­to di­rect con­tact with the study drug — may not seem like a big pri­or­i­ty for drug de­vel­op­ment ex­ec­u­tives. And that would be a mis­take.

As we’ll learn, pack­ag­ing and pre­sen­ta­tion is cru­cial to study suc­cess. Drug sta­bil­i­ty, reg­u­la­to­ry strat­e­gy, and pa­tient-cen­tered de­sign are just some of the fac­tors to con­sid­er. In this Deep Dive, we talked with sci­en­tif­ic ex­perts at con­tract de­vel­op­ment and man­u­fac­tur­er Catal­ent and ex­plored these ques­tions:

  • How does pack­ag­ing change from small phase I tri­als to large mul­ti-cen­ter phase III ef­forts?
  • What are the best pack­ag­ing strate­gies to achieve longer sta­bil­i­ty?
  • What are the dif­fer­ences be­tween the US and Eu­rope for ex­piry dates on pack­ag­ing?
  • Can you best source com­para­tor ther­a­pies with­out be­ing charged a for­tune?
  • How can de­vel­op­ers best pack­age for ad­her­ence?

Plan­ning a clin­i­cal sup­ply pro­gram? Keep read­ing for an­swers to these ques­tions and many more.

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