Advancing product quality: a summary of the second FDA/PQRI conference
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Unlike traditional drug formulations, similar physicochemical properties of nano-based pharmaceuticals are often not a predictor of similar in vivo behavior.
“Unlike in traditional drug formulations, similar physicochemical properties of nano-based pharmaceuticals are not often a predictor of similar in vivo behavior [288, 293, 295]”
From Polymeric micelles for the delivery of poorly soluble drugs: From nanoformulation to clinical approval. (2020) · cites this paper as [295]
The “Characterization of Complex Drug Formulations Containing Nanomaterials” section says size alone is insufficient to characterize these products and that other attributes often affect performance. It does not establish that similar physicochemical properties often fail to predict similar in vivo behavior, or make the claimed comparison with traditional formulations. No page number is available in our copy. (LLM, conf=0.82)
Experimental — accuracy not yet measuredThere is no distinct or definitive set of critical quality attributes that can accurately predict in vivo similarity of two distinct nano-based pharmaceuticals or biologic products.
“That is, there is not a distinct or definitive set of critical quality attributes (CQAs), which can accurately predict the in vivo similarity of two distinct nano-based pharmaceuticals or biologic products.”
From Polymeric micelles for the delivery of poorly soluble drugs: From nanoformulation to clinical approval. (2020) · cites this paper as [295]
The “Characterization of Complex Drug Formulations Containing Nanomaterials” section says CQAs are product-specific and that attributes beyond size can affect product performance. The “Biosimilar Product Assessment” section likewise describes product-specific assessment of quality attributes. Neither section establishes the stronger claim that no set of CQAs can accurately predict in vivo similarity between two nano-based pharmaceuticals or biologic products. The indexed passages provide no page numbers. (LLM, conf=0.84)
Experimental — accuracy not yet measuredA wide variety of evidence, including long-term clinical monitoring and extensive PK data, is needed to show equivalence of nano-based pharmaceuticals.
“Thus, a wide variety of evidence is needed to show equivalence which includes long term clinical monitoring and extensive PK data [288, 293–295].”
From Polymeric micelles for the delivery of poorly soluble drugs: From nanoformulation to clinical approval. (2020) · cites this paper as [295]
The section “Characterization of Complex Drug Formulations Containing Nanomaterials” (page unavailable) supports the need to assess multiple product-specific attributes, including size distribution, morphology, drug release, and surface charge. It does not say that long-term clinical monitoring or extensive PK data are needed to demonstrate equivalence of nano-based pharmaceuticals; the PK studies mentioned elsewhere concern biosimilars. (LLM, conf=0.85)
Experimental — accuracy not yet measured
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Cites
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Cited by
Sorted by citations
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- Authors
- Yu, L. X., Akseli, I., Allen, B., Amidon, G., Bizjak, T. G., Boam, A., Caulk, M., Doleski, D., Famulare, J., Fisher, A. C., Furness, S., Hasselbalch, B., Havel, H., Hoag, S. W., Iser, R., Johnson, B. D., Ju, R., Katz, P., Lacana, E., Lee, S. L., Lostritto, R., McNally, G., Mehta, M., Mohan, G., Nasr, M., Nosal, R., Oates, M., O’Connor, T., Polli, J., Raju, G. K., Ramanadham, M., Randazzo, G., Rosencrance, S., Schwendeman, A., Selen, A., Seo, P., Shah, V., Sood, R., Thien, M. P., Tong, T., Trout, B. L., Tyner, K., Vaithiyalingam, S., VanTrieste, M., Walsh, F., Wesdyk, R., Woodcock, J., Wu, G., Wu, L., Yu, L., & Zezza, D.
- Affiliations
- United States Food and Drug Administration (US)
- Boehringer Ingelheim (United States) (US)
- Eli Lilly (United States) (US)
- University of Michigan (US)
- Roche (United States) (US)
- University of Maryland, Baltimore (US)
- Perrigo (United States) (US)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- GlaxoSmithKline (United States) (US)
- Pfizer (United States) (US)
- Teva Pharmaceuticals (United States) (US)
- Massachusetts Institute of Technology (US)
- Amgen (United States) (US)
- Novartis (United States) (US)
- Corresponding author
- Yu, Lawrence X.
- Yu, Louis
- ORCID
- Venue
- The AAPS Journal
- Published
- 2016-02-09
- Volume
- 18
- Issue
- 2
- Pages
- 528-543
- ISSN
- 1550-7416 (ISSN-L)
- PMC
- PMC4779106
- OpenAlex
- W2265041591
- Cited by
- 33
- References
- 20
- Citations by year
- 2026: 3 · 2025: 5 · 2023: 2 · 2022: 4 · 2021: 2 · 2020: 2 · 2019: 3 · 2018: 6 · 2017: 3 · 2016: 2 · 2015: 1
- FWCI
- 9.08
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- The AAPS Journal (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute of General Medical Sciences (R01GM113832)
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
- Keywords
- FDA, quality risk management, abbreviated new drug application, new drug applications, quality metrics, dissolution testing, continuous production, 3D-printed drugs, biosimilars, quality by design, generic drugs, pharmaceutical quality assurance, regulatory guidelines
- MeSH terms
- Chemistry, Pharmaceutical, Congresses as Topic, Drug Industry, Humans, Quality Control, United States, United States Food and Drug Administration
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