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Variability Assessment Methods for Lyophilized Drug Product, A Case Study

Year: 2025

Type: article

Source: PDA Journal of Pharmaceutical Science and Technology

DOI: 10.5731/pdajpst.2025-000046.1

Authors: Ajay Babu Pazhayattil, Marzena Ingram, Prasanna Sagar, Kishorkumar Kotini, Abhijit Bodhe, Mallinath Harwalkar, Satish Joshi, Subrata Chakraborty, Rajesh Sreedharan Nair, Ahmed Shaaban Elsaid

Institutions: Intas Pharmaceuticals (India), Hetero Drugs (India), University of Nottingham, University of Nottingham Malaysia Campus, Thermo Fisher Scientific (United States), Thermo Fisher Scientific (Israel)

Language: English

Topic: Analytical Methods in Pharmaceuticals

Subfield: Analytical Chemistry

Field: Chemistry

Domain: Physical Sciences

Open Access status: closed

OpenAlex ID: W4416581855

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