A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14160%2F21%3A00119760" target="_blank" >RIV/00216224:14160/21:00119760 - isvavai.cz</a>
Alternative codes found
RIV/00216275:25310/21:39918028
Result on the web
<a href="https://www.mdpi.com/1999-4923/13/10/1703" target="_blank" >https://www.mdpi.com/1999-4923/13/10/1703</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.3390/pharmaceutics13101703" target="_blank" >10.3390/pharmaceutics13101703</a>
Alternative languages
Result language
angličtina
Original language name
A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products
Original language description
A drug dissolution profile is one of the most critical dosage form characteristics with immediate and controlled drug release. Comparing the dissolution profiles of different pharmaceutical products plays a key role before starting the bioequivalence or stability studies. General recommendations for dissolution profile comparison are mentioned by the EMA and FDA guidelines. However, neither the EMA nor the FDA provides unambiguous instructions for comparing the dissolution curves, except for calculating the similarity factor f(2). In agreement with the EMA and FDA strategy for comparing the dissolution profiles, this manuscript provides an overview of suitable statistical methods (CI derivation for f(2) based on bootstrap, CI derivation for the difference between reference and test samples, Mahalanobis distance, model-dependent approach and maximum deviation method), their procedures and limitations. However, usage of statistical approaches for the above-described methods can be met with difficulties, especially when combined with the requirement of practice for robust and straightforward techniques for data evaluation. Therefore, the bootstrap to derive the CI for f(2) or CI derivation for the difference between reference and test samples was selected as the method of choice.<p> </p>
Czech name
—
Czech description
—
Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
—
OECD FORD branch
30104 - Pharmacology and pharmacy
Result continuities
Project
<a href="/en/project/QK1810221" target="_blank" >QK1810221: Using of microparticles as carriers of hormonally active substances in artificial reproduction of fish.</a><br>
Continuities
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)
Others
Publication year
2021
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Pharmaceutics
ISSN
1999-4923
e-ISSN
1999-4923
Volume of the periodical
13
Issue of the periodical within the volume
10
Country of publishing house
CH - SWITZERLAND
Number of pages
12
Pages from-to
1-12
UT code for WoS article
000714524900001
EID of the result in the Scopus database
2-s2.0-85117888064