Handbook of Bioequivalence Testing
Abstract
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m
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Disintegration is directly related to dissolution and subsequent bioavailability of a drug.
“Disintegration must be directly related to dissolution and subsequent bioavailability of a drug [45].”
From In vitro quality evaluation of leading brands of ciprofloxacin tablets available in Bangladesh (2017) · cites this paper as [45]
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In vitro quality evaluation of leading brands of ciprofloxacin tablets available in Bangladesh
Uddin, M. S., Mamun, A. A., Hossain, M. S., Asaduzzaman, M., Sarwar, M. S., Rashid, M., & Herrera-Calderon, O. (2017) · BMC Research Notes · doi:10.1186/s13104-017-2507-y · Cited by 31 · see citing works
- Authors
- Niazi, S. K.
- Corresponding author
- Niazi, Sarfaraz K.
- ORCID
- Niazi, Sarfaraz K.
- Venue
- CRC Press eBooks
- Publisher
- CRC Press
- Published
- 2007-08-22
- OpenAlex
- W2890544003
- Cited by
- 77
- References
- 0
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 2 · 2023: 2 · 2022: 15 · 2021: 9 · 2020: 3 · 2019: 3 · 2018: 4 · 2017: 2 · 2016: 9 · 2015: 2 · 2014: 5 · 2013: 3 · 2012: 4
- FWCI
- 0.75
- Type
- book
- Language
- en
- Open access
- closed
- Locations
- CRC Press eBooks (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- bioequivalence testing, generic drugs, bioequivalence study design
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 ›
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