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Key Factors to Design Quality Stability Program for Drug Product and API Kim Huynh-Ba PHARMALYTIK Pharmalytik© OVERVIEW • Stability role in the drug development process…

Documents Stability Q1(R2). Role Of Stability Safety and efficacy of drug product are established during...

Slide 1 Stability Q1(R2) Slide 2 Role Of Stability Safety and efficacy of drug product are established during development via clinical studies Quality is established for…

Documents Stability Q1(R2)

Stability Q1(R2) Role Of Stability ⢠Safety and efficacy of drug product are established during development via clinical studies ⢠Quality is established for identify,…