A Critical Overview of FDA and EMA Statistical Methods to
Compare In Vitro Drug Dissolution Profiles of Pharmaceutical
Products

J 2021

A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products

MUSELÍK, Jan; A. KOMERSOVA; Kateřina KUBOVÁ; K. MATZICK; B. SKALICKA et al.

Základní údaje

Originální název

A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products

Autoři

MUSELÍK, Jan; A. KOMERSOVA; Kateřina KUBOVÁ ; K. MATZICK a B. SKALICKA

Vydání

Pharmaceutics, BASEL, MDPI, 2021, 1999-4923

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30104 Pharmacology and pharmacy

Stát vydavatele

Švýcarsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 6.525

Kód RIV

RIV/00216224:14160/21:00119760

Organizační jednotka

Farmaceutická fakulta

DOI

https://doi.org/10.3390/pharmaceutics13101703

UT WoS

000714524900001

EID Scopus

2-s2.0-85117888064

Klíčová slova anglicky

drug dissolution; dissolution profile comparison; EMA and FDA strategy

Štítky

rivok, ÚFT

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 14. 4. 2022 15:25, JUDr. Sabina Gajdzioková

Anotace

V originále

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.

Návaznosti

MUNI/A/1574/2020, interní kód MU

Název: Pokročilé technologie pro přípravu a hodnocení částicových systémů

Investor: Masarykova univerzita, Pokročilé technologie pro přípravu a hodnocení částicových systémů

QK1810221, projekt VaV

Název: Využití mikročástic jako nosičů hormonálně aktivních látek v řízené reprodukci ryb.

Investor: Ministerstvo zemědělství ČR, Využití mikročástic jako nosičů hormonálně aktivních látek v řízené reprodukci ryb.

Citovat

MUSELÍK, Jan; A. KOMERSOVA; Kateřina KUBOVÁ; K. MATZICK a B. SKALICKA. A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products. Pharmaceutics. BASEL: MDPI, 2021, roč. 13, č. 10, s. 1-12. ISSN 1999-4923. Dostupné z: https://doi.org/10.3390/pharmaceutics13101703.

@article{1805119,
   author = {Muselík, Jan and Komersova, A. and Kubová, Kateřina and Matzick, K. and Skalicka, B.},
   article_location = {BASEL},
   article_number = {10},
   doi = {https://doi.org/10.3390/pharmaceutics13101703},
   keywords = {drug dissolution; dissolution profile comparison; EMA and FDA strategy},
   language = {eng},
   issn = {1999-4923},
   journal = {Pharmaceutics},
   title = {A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products},
   url = {https://www.mdpi.com/1999-4923/13/10/1703},
   volume = {13},
   year = {2021}
}

TY  - JOUR
ID  - 1805119
AU  - Muselík, Jan - Komersova, A. - Kubová, Kateřina - Matzick, K. - Skalicka, B.
PY  - 2021
TI  - A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products
JF  - Pharmaceutics
VL  - 13
IS  - 10
SP  - 1-12
EP  - 1-12
PB  - MDPI
SN  - 19994923
KW  - drug dissolution
KW  - dissolution profile comparison
KW  - EMA and FDA strategy
UR  - https://www.mdpi.com/1999-4923/13/10/1703
N2  - 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.

ER -

MUSELÍK, Jan; A. KOMERSOVA; Kateřina KUBOVÁ; K. MATZICK a B. SKALICKA. A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products. \textit{Pharmaceutics}. BASEL: MDPI, 2021, roč.~13, č.~10, s.~1-12. ISSN~1999-4923. Dostupné z: https://doi.org/10.3390/pharmaceutics13101703.

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