The DOI matches its Crossref record.
Quality by Design: Concepts for ANDAs
Open accessAbstract
Quality by design is an essential part of the modern approach to pharmaceutical quality. There is much confusion among pharmaceutical scientists in generic drug industry about the appropriate element and terminology of quality by design. This paper discusses quality by design for generic drugs and presents a summary of the key terminology. The elements of quality by design are examined and a consistent nomenclature for quality by design, critical quality attribute, critical process parameter, critical material attribute, and control strategy is proposed. Agreement on these key concepts will allow discussion of the application of these concepts to abbreviated new drug applications to progress.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cited by
Understanding pharmaceutical quality by design
Yu, L. X., Amidon, G., Khan, M. A., Hoag, S. W., Polli, J., Raju, G. K., & Woodcock, J. (2014) · The AAPS Journal · doi:10.1208/s12248-014-9598-3 · Cited by 1,475
Self-citationMascia, S., Heider, P. L., Zhang, H., Lakerveld, R., Benyahia, B., Barton, P. I., Braatz, R. D., Cooney, C. L., Evans, J. M. B., Jamison, T. F., et al. (2013) · Angewandte Chemie International Edition · doi:10.1002/anie.201305429 · Cited by 599
Grangeia, H. B., Silva, C., Simões, S. P., & Reis, M. S. (2020) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/j.ejpb.2019.12.007 · Cited by 257
Metadata
- Authors
- Lionberger, R. A., Lee, S. L., Lee, L., Raw, A., & Yu, L. X.
- Venue
- The AAPS Journal
- Published
- 2008-05-09
- Volume
- 10
- Issue
- 2
- Pages
- 268-276
- ISSN
- 1550-7416 (ISSN-L)
- OpenAlex
- W1998154903
- Cited by
- 391
- References
- 0
- FWCI
- 7.74
- Type
- journal article
- Language
- en
- Open access
- hybrid
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
How to cite
Cite CoChat for the checks on this page, and the paper for its own findings.
- This page
- CoChat. (2026). Citation check: Quality by Design: Concepts for ANDAs. https://app.cochat.ai/papers/10.1208/s12248-008-9026-7
- The paper
- Lionberger, R. A., Lee, S. L., Lee, L., Raw, A., & Yu, L. X. (2008). Quality by Design: Concepts for ANDAs. The AAPS Journal. https://doi.org/10.1208/s12248-008-9026-7
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
