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Review ArticleReview

A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management

Maria Ana Martins da Cruz Borges Batalha, Daniel Alexandre Marques Pais, Rui Alexandre Estrela de Almeida and Ângela Sofia Gomes Martinho
PDA Journal of Pharmaceutical Science and Technology September 2024, 78 (5) 604-612; DOI: https://doi.org/10.5731/pdajpst.2023.012922
Maria Ana Martins da Cruz Borges Batalha
Valgenesis Portugal, Lda
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Daniel Alexandre Marques Pais
Valgenesis Portugal, Lda
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Rui Alexandre Estrela de Almeida
Valgenesis Portugal, Lda
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Ângela Sofia Gomes Martinho
Valgenesis Portugal, Lda
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Article Information

vol. 78 no. 5 604-612
DOI 
https://doi.org/10.5731/pdajpst.2023.012922
PubMed 
39164115

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 22, 2024.

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  • previous version (August 20, 2024 - 13:20).
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© PDA, Inc. 2024

Author Information

  1. Maria Ana Martins da Cruz Borges Batalha*,1,
  2. Daniel Alexandre Marques Pais2,
  3. Rui Alexandre Estrela de Almeida and
  4. Ângela Sofia Gomes Martinho
  1. Valgenesis Portugal, Lda
  1. ↵* Corresponding Author: Rua Castilho, No. 50, 4th floor, 1250-071, Lisbon, Portugal; Telephone: +351216062788; E-mail: maria.batalha{at}valgenesis.com
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PDA Journal of Pharmaceutical Science and Technology: 78 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 5
September/October 2024
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A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management
Maria Ana Martins da Cruz Borges Batalha, Daniel Alexandre Marques Pais, Rui Alexandre Estrela de Almeida, Ângela Sofia Gomes Martinho
PDA Journal of Pharmaceutical Science and Technology Sep 2024, 78 (5) 604-612; DOI: 10.5731/pdajpst.2023.012922

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A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management
Maria Ana Martins da Cruz Borges Batalha, Daniel Alexandre Marques Pais, Rui Alexandre Estrela de Almeida, Ângela Sofia Gomes Martinho
PDA Journal of Pharmaceutical Science and Technology Sep 2024, 78 (5) 604-612; DOI: 10.5731/pdajpst.2023.012922
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  • Article
    • Abstract
    • Introduction
    • Regulatory Context of AI and ML in Healthcare
    • AI and ML for Early Drug Development and Process Design
    • AI and ML for Process Performance Qualification
    • AI and ML for Continued Process Verification
    • The Use of Digital Twins Throughout the Product Life Cycle
    • AI and ML for Risk Assessment Throughout the Product Life Cycle
    • Final Remarks
    • Conflict of Interest Declaration
    • Footnotes
    • References
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More in this TOC Section

  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
  • Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
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Keywords

  • Life cycle management
  • Artificial Intelligence
  • machine learning
  • Pharma 4.0
  • Digitalization
  • Pharma and biopharma

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