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Therapeutic Innovation & Regulatory Science
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June 20, 2020
A Quantitative Study of US FDA Inspection Data for Drug Manufacturing Sites
Ajay Babu Pazhayattil, Marzena Ingram, Naheed Sayeed
PDA Journal of Pharmaceutical Science and Technology
|
April 18, 2026
Application of Stage 3a Heightened Monitoring to Close Process Knowledge Gaps of Legacy Injectable Products: A Commercial Scale Case Study
Ajay Babu Pazhayattil, Avinash Joshi, Marzena Ingram
PDA Journal of Pharmaceutical Science and Technology
|
February 16, 2020
A Semiquantitative Risk Assessment Methodology Fit for Biopharmaceutical Life Cycle Stages
Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Shu Chen, et al.
AAPS Pharmscitech
|
September 10, 2015
Stage 2 Process Performance Qualification (PPQ): a Scientific Approach to Determine the Number of PPQ Batches
Ajay Pazhayattil, Daniel Alsmeyer, Shu Chen, et al.
AAPS Pharmscitech
|
October 8, 2016
Assessment Methodology for Process Validation Lifecycle Stage 3A
Naheed Sayeed-Desta, Ajay Babu Pazhayattil, Jordan Collins, et al.
PDA Journal of Pharmaceutical Science and Technology
|
November 24, 2025
Variability Assessment Methods for Lyophilized Drug Product, A Case Study
Ajay Babu Pazhayattil, Marzena Ingram, Prasanna Sagar, et al.
Page
of 1
Search research articles
Search
Showing results (1-10 of 6) with videos related to
Sort By:
Page
of 1
Therapeutic Innovation & Regulatory Science
|
June 20, 2020
A Quantitative Study of US FDA Inspection Data for Drug Manufacturing Sites
Ajay Babu Pazhayattil, Marzena Ingram, Naheed Sayeed
PDA Journal of Pharmaceutical Science and Technology
|
April 18, 2026
Application of Stage 3a Heightened Monitoring to Close Process Knowledge Gaps of Legacy Injectable Products: A Commercial Scale Case Study
Ajay Babu Pazhayattil, Avinash Joshi, Marzena Ingram
PDA Journal of Pharmaceutical Science and Technology
|
February 16, 2020
A Semiquantitative Risk Assessment Methodology Fit for Biopharmaceutical Life Cycle Stages
Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Shu Chen, et al.
AAPS Pharmscitech
|
September 10, 2015
Stage 2 Process Performance Qualification (PPQ): a Scientific Approach to Determine the Number of PPQ Batches
Ajay Pazhayattil, Daniel Alsmeyer, Shu Chen, et al.
AAPS Pharmscitech
|
October 8, 2016
Assessment Methodology for Process Validation Lifecycle Stage 3A
Naheed Sayeed-Desta, Ajay Babu Pazhayattil, Jordan Collins, et al.
PDA Journal of Pharmaceutical Science and Technology
|
November 24, 2025
Variability Assessment Methods for Lyophilized Drug Product, A Case Study
Ajay Babu Pazhayattil, Marzena Ingram, Prasanna Sagar, et al.
Page
of 1