Research ArticleTechnology/Application
Artificial Intelligence Algorithm Qualification: A Quality by Design Approach to Apply Artificial Intelligence in Pharma
Toni Manzano, Cristina Fernàndez, Toni Ruiz and Hugo Richard
PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 100-118; DOI: https://doi.org/10.5731/pdajpst.2019.011338
Toni Manzano
1Bigfinite, Corcega 301, Barcelona 08008, Spain; and
2AI Xavier University, 3800 Victory Pkwy, Cincinnati, OH 45207.
Cristina Fernàndez
1Bigfinite, Corcega 301, Barcelona 08008, Spain; and
Toni Ruiz
1Bigfinite, Corcega 301, Barcelona 08008, Spain; and
Hugo Richard
1Bigfinite, Corcega 301, Barcelona 08008, Spain; and

References
- 1.↵
- Huang M.-H.,
- Rust R. T.
- 2.↵
- Penrose R.,
- Mermin N. D.
- 3.↵
- Naimat A.
- 4.↵
- Kaur N.,
- Sood S. K.
- 5.↵Data Science: Opportunities to Transform Chemical Sciences and Engineering: Proceedings of a Workshop—In Brief. The National Academies Press: Washington, DC, 2018.
- 6.↵
- Price W. N.
- 7.↵, Quality Guideline Q8(R2): Pharmaceutical Development, Step 4. ICH: Geneva, 2009.
- 8.↵
- Herwig C.,
- Wölbeling C.,
- Zimmer T.
- 9.↵, Quality Guideline Q9: Quality Risk Management, Step 4. ICH: Geneva, 2005.
- 10.↵, ICH Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology. EMA: London, 1995.
- 11.↵
- Peterson J. J.,
- Snee R. D.,
- McAllister P. R.,
- Schofield T. L.,
- Carella A. J.
- 12.↵
- Zhang G.,
- Hu M. Y.,
- Patuwo B. E.,
- Indro D. C.
- 13.↵Review of Particle Physics. Phys. Rev. D 2018, 98 (3), 030001.
- 14.↵
- Diamantidis N.,
- Karlis D.,
- Giakoumakis E.
- 15.↵
- Hastie T.,
- Tibshirani R.,
- Friedman J.
- 16.↵
- Smith R.,
- Ventura D.,
- Prince J. T.
- 17.↵
- Saurwein F.,
- Just N.,
- Latzer M.
- 18.↵
- Chu L. P.
- 19.↵
- Kent A.,
- Williams J.
- 20.↵
- 21.↵
- Gao J.,
- Tao C.,
- Jie D.,
- Lu S.
- 22.↵, Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments. PIC/S: Geneva, 2018.
- 23.↵
- Witjas-Paalberends E. R.,
- van Laarhoven L. P. M.,
- van de Burgwal L. H. M.,
- Feilzer J.,
- de Swart J.,
- Claassen E.,
- Jansen W. T. M.
- 24.↵
- Barlow M.
- 25.↵, Annex 5: Guidance on Good Data and Record Management Practices. WHO, 2016.
- 26.↵, ‘GXP' Data Integrity Guidance and Definitions, Rev. 1. MHRA: London, 2018.
- 27.↵, European Pharmacopoeia (Ph. Eur.), 9th edition, Council of Europe: Strasbourg, France, 2017.
- 28.↵
- Menzies T.
- 29.↵, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)—Discussion Paper and Request for Feedback. FDA, 2019.
- 30.↵, HMA-EMA Joint Big Data Taskforce. Summary Report; EMA/105321/2019. EMA: London, 2019.
- 31.↵
- Guinée J. B.,
- Lindeijer E.
- 32.↵
- 33.↵
- 34.↵
- Frankish K.,
- Ramsey W. M.
- 35.↵
- Moor J.
- 36.↵
- Markarian J.
- 37.↵
- Mockute R.,
- Desai S.,
- Perera S.,
- Assuncao B.,
- Danysz K.,
- Tetarenko N.,
- Gaddam D.,
- Abatemarco D.,
- Widdowson M.,
- Beauchamp S.,
- Cicerello S.,
- Mingle E.
- 38.↵Case study: Artificial Intelligence and Machine Learning: Revolutionising Drug Development; IMED Annual Review, 2017.
- 39.↵
- Ferreira A. P.,
- Tobyn M.
- 40.↵Analysis Techniques for System Reliability—Procedures for Failure Mode and Effects Analysis (FMEA); IEC 60812:2006(E); IEC: Geneva, 2006.
- 41.↵, USP 29—NF 24, USP: Rockville, MD, 2006.
- 42.↵
- McCarthy J.
- 43.↵, Quality Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, Step 2. ICH: Geneva, 2017.
- 44.↵
- Rowley A.,
- Turpin R.,
- Walton S.
- 45.↵
- Norton M.,
- Karczub D.
- 46.↵
- Liu F. T.,
- Ting K. M.,
- Zhou Z.-H.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 1
January/February 2021
Artificial Intelligence Algorithm Qualification: A Quality by Design Approach to Apply Artificial Intelligence in Pharma
Toni Manzano, Cristina Fernàndez, Toni Ruiz, Hugo Richard
PDA Journal of Pharmaceutical Science and Technology Jan 2021, 75 (1) 100-118; DOI: 10.5731/pdajpst.2019.011338
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