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Excipients knowledge management IFPAC 2016

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We are defining the problem too narrowly. Our paradigm of pharmaceutical quality sifted long-ago. We have harmonized on a regulatory methodology for QbD (e.g., ICH Q8). However, with the prevailing ontological gaps (for example as illustrated in the continuing challenges posed with the current FDA’s Inactive Ingredient Database) - How good are the scientific explanations in regulatory submissions? Is quality risk-assessment - metaphysical or an epistemological category?

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Excipients knowledge management IFPAC 2016

  1. 1. EXCIPIENTS KNOWLEDGE MANAGEMENT: CHALLENGES & SOLUTIONS AJAZ S. HUSSAIN, PH.D., THE NATIONAL INSTITUTE OF PHARMACEUTICAL TECHNOLOGY & EDUCATION IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 1
  2. 2. Outline • PharmaHUB: NIPTE-FDA Excipients Knowledge BaseBackground • Constraints on effective use and reuse of prior knowledge in regulatory decision-makingChallenge • Are we defining the problem too narrowly?Question • An opportunity to collaborate and build on the work already done - NIPTE-FDA Excipients Knowledge BaseAnswers IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 2
  3. 3. NIPTE-FDA Excipients Knowledge Base An online resource that offers a searchable repository for excipient property measurement data Funded FDA U01 grant; NSF funding used to set up PharmaHub database infrastructure Neutral forum to bring excipient suppliers and users together to share knowledge to improve excipient usage and performance IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 3 Prabir K Basu; Mansoor A Khan; Steve Hoag; Carl Wassgren; Ann Christine Catlin; Sudheera R. Fernando; Sumudinie Fernando; Kristine Margaret Alston; Ting Wang; Linas Mockus (2011), "NIPTE-FDA Excipients Knowledge Base," https://pharmahub.org/resources/458
  4. 4. PHARMAHUB IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 4
  5. 5. Computational environment with visualization and data mining tools IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 5
  6. 6. Outline • PharmaHUB: NIPTE-FDA Excipients Knowledge BaseBackground • Constraints on effective use and reuse of prior knowledge in regulatory decision-makingChallenge • Are we defining the problem too narrowly?Question • An opportunity to collaborate and build on the work already done - NIPTE-FDA Excipients Knowledge BaseAnswers IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 6
  7. 7. Constraints on effective use and reuse of prior knowledge in the regulatory context • Challenges illustrated in the gaps and issues with the ‘Inactive Ingredient Database’ • Excipient functionality and process capability can no longer be ignored for many “complex’ drug delivery systems • Constraints in ability to account for excipient variability in the context of impact on CQA’s, risk assessment and ‘Black Swan’ (per Brian Carlin) • CGMP deviations, investigations and effectives of CAPA IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 7
  8. 8. Outline • PharmaHUB: NIPTE-FDA Excipients Knowledge BaseBackground • Constraints on effective use and reuse of prior knowledge in regulatory decision-makingChallenge • Are we defining the problem too narrowly?Question • An opportunity to collaborate and build on the work already done - NIPTE-FDA Excipients Knowledge BaseAnswers IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 8
  9. 9. Are we defining the problem too narrowly? Current status of ‘Substances In Regulatory Practice’ • Global Ingredients Archive System (GInAS) • ISO 11238 (ISO IDMP), some challenges FDA’s Inactive Ingredient Database - status? •Substance Registration System (SRS) •Generic listing vs. Specific Grade listing – max. precedent levels •Listing of Mixtures? •The UNII code confusing, the National Library of Medicine yet to finalize standards for assigning UNII codes for polymers •Individual Grades vs. Family Data •Legal status of the IID, and FDA communications of changes to the IID •DMF Implications, impact on ANDAs – ‘Delays’ & ‘Refuse to File Letters’ IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 9
  10. 10. What about? EMA-FDA pilot program for parallel assessment of Quality- by-Design applications IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 10
  11. 11. ICH Q8 outlined a Methodology for QbD; however Some methods we use (e.g., excipient COA/USP) may no longer be adequate Our epistemology (explanations – how do you know what you know) is too often unconvincing We have significant ontological gaps and we risk black swans IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 11 Paradigm shifted long-ago from ‘compounding’ to manufacturing & from testing –to-document quality to Quality by Design In the context of knowledge sharing ontology is a specification of a conceptualization (enabling knowledge sharing and reuse); in philosophy it refers to the subject of existence http://www-ksl.stanford.edu/kst/what-is-an- ontology.html
  12. 12. Outline • PharmaHUB: NIPTE-FDA Excipients Knowledge BaseBackground • Constraints on effective use and reuse of prior knowledge in regulatory decision-makingChallenge • Are we defining the problem too narrowly?Question • An opportunity to collaborate and build on the work already done - NIPTE-FDA Excipients Knowledge BaseAnswers IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 12
  13. 13. We are defining the problem too narrowly • We have harmonized on a regulatory methodology for QbD (e.g., ICH Q8) Our paradigm of pharmaceutical quality sifted long-ago • How good are the scientific explanations in regulatory submissions? • Risk-assessment - metaphysical or an epistemological category? However, with the prevailing ontological gaps (for example as illustrated in the continuing challenges posed with the current FDA’s Inactive Ingredient Database) IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 13
  14. 14. Speed to market and getting it right the first time: Improve pharmaceutical knowledge management IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 14 Venkat Venkatasubramanian; Rex Reklaitis; Leaelaf Hailemariam; Shuo-Huan Hsu; Pradeep Suresh (2007), "Pharmaceutical Informatics," https://pharmahub.org/resources/30
  15. 15. Summary • Shifted long ago; regulatory methodology outlined for QbDParadigm • Serious gaps; unconvincing epistemologyOntology? • Our risk-assessment - metaphysical or an epistemological category?Risk • Work already done on the NIPTE-FDA Excipients Knowledge BaseLeverage IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 15 In the context of knowledge sharing ontology is a specification of a conceptualization (enabling knowledge sharing and reuse)
  16. 16. NIPTE-FDA Excipients Knowledge Base Contact at NIPTE • Stephen W. Hoag, Ph.D. • University of Maryland, Baltimore • School of Pharmacy • Phone 410-706-6865 • Email: shoag@rx.umaryland.edu IFPAC® Annual Meeting, Jan. 24 - Jan. 27, 2016 . Arlington, VA, U.S.A 16

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