PDA journal of pharmaceutical science and technology
Variability Assessment Methods for Lyophilized Drug Product, A Case Study.
Ajay Babu Pazhayattil, Marzena Ingram, Prasanna Sagar, Kishorkumar Kotini, Abhijit Bodhe, Mallinath Harwalkar, Satish Joshi, Subrata Chakraborty, Rajesh Sreedharan Nair, Ahmed Shaaban Elsaid
Published: 202510.5731/pdajpst.2025-000046.1
Abstract
Lyophilization is a critical process, removing water and or solvent through sublimation to ensure the stability and longevity of injectable drug products. The complexity of the lyophilization process, involving multiple stages such as freezing, prima…
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