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- Comparative dissolution profile is a dissolution profile comparison between reference product and test product for biowaiver considerations and SUPAC after the product is approved.
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When dissolution profiles or a similar term is used in this guidance, data should be generated in a comparative manner as follows: At least 12 dosage units (e.g. tablets, capsules) of each batch must be tested individually, and mean and individual results reported.
Oct 1, 2015 · The objective of this article is to compare and contrast the international expectations associated with the model-independent similarity factor approach to comparing dissolution profiles. This comparison highlights globally divergent regulatory requirements to meet local dissolution similarity requirements. In effect, experiments customized to ...
- Dorys Argelia Diaz, Stephen T. Colgan, Connie S. Langer, Nagesh T. Bandi, Michael D. Likar, Leslie V...
- 2016
- Model-Independent Approach Using A Similarity Or Difference Factor
- Independent Multivariate Confidence Region Procedure (Bootstrap Approach) Method
- Acceptance Criteria
- Limitations/Disadvantages of The Bootstrapping Approach
- Mahalanobis Distance Concept
- Mahalanobis distance: Different Equivalence Procedures
Similarity Factor f2
In 1996, Moore and Flanner proposed two factors (f1 and f2) to compare dissolution profiles. They constitute a simple model-independent approach. f2 is easy to calculate and provides a clear acceptance criterion for dissolution profile similarity comparison ; it has been strongly recommended by global regulatory authorities, the World Health Organization (WHO), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) [7, 9, 11, 12] a...
Difference Factor f1
f1 reflects the accumulative difference between two dissolution curves in every evaluated time point and represents a relative mean error between the two curves. f1 is the function of the average absolute difference between the two dissolution curves [4, 8]. The similarity factor f1should be estimated by using the following formula: where n represents the number of time points, Rt denotes the mean percent reference drug dissolved at time t after initiation of the study, and Tt symbolizes the...
This method uses bootstrapping (a resampling technique to generate slightly different data sets from the original one) to estimate the dispersion of the data. It can be applied when the variability exceeds that allowed for f2. It uses the f2 factor as a confidence interval more than a f2 point estimate which renders to the safety buffer [7, 10]. ...
Two dissolution profiles are considered similar when the f2 lower bound of the confidence interval is ≥50 [4, 7, 10].
Analogously to f2, the bootstrapping approach is based on a nonstandardized distance measurement between two dissolution profiles. That is, the absolute differences at different sample time points are not weighted by their respective variance . Furthermore, it provides poor control of the Type I error rate . Note that Type I error involves rejectin...
Hoffelder proposes the use of the Mahalanobis distance as a measure of dissimilarity according to Eqs. 3 and 4: Estimated by where δ2 represents “MD,” μ is the population mean, and μ1, y, and μ2 are estimated from \( \overline{X} \) and \( \overline{Y} \) (mean value of X and Y, respectively which correspond to random vectors of the same length th...
Different equivalence procedures for the comparison of dissolution profiles based on MD have been reported [7, 15]. For instance, Tsong et al. were the first to propose the use of the Mahalanobis statistical distance as a measure of the difference between two dissolution profiles. This approach has been named multivariate statistical distance (MSD...
- pq@biol.unlp.edu.ar
Dec 29, 2022 · Comparative dissolution profile is a dissolution profile comparison between reference product and test product for biowaiver considerations and SUPAC after the product is approved. Comparative Dissolution as per USP
The SUPAC-IR guidance recommends dissolution profile comparisons for approving different levels of changes and documenting product sameness. between the test (postchange) and...
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- X:TRANSFERGUIDANCEFINALy3BP1.PDF
- Monday, August 25, 1997 8:58:30 AM
Oct 15, 2021 · 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.
This article presents a short review on guidelines for dissolution profile testing, particularly focusing on the recommendations regarding statistical methods for assessing profile similarity.
