| 000 -LEADER |
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a |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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20220208153330.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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220208b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE |
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AIKTC-KRRC |
| Transcribing agency |
AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME |
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| 9 (RLIN) |
15955 |
| Author |
Ghasemian, Elham |
| 245 ## - TITLE STATEMENT |
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| Title |
Analytical method validation, pharmacokinetics and bioequivalence study of dimethyl fumarate in healthy iranian volunteers |
| 250 ## - EDITION STATEMENT |
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| Volume, Issue number |
Vol.13(9) |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Place of publication, distribution, etc. |
M P |
| Name of publisher, distributor, etc. |
Innovare Academic Sciences Pvt Ltd |
| Year |
2021 |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Pagination |
6-10p. |
| 520 ## - SUMMARY, ETC. |
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| Summary, etc. |
Objective: Pharmacokinetic evaluation of Dimethyl Fumarate (DMF) in the Iranian population wasn’t studied. So, the aim of this research is the validation of the analytical method and evaluation of the pharmacokinetic properties and bioequivalence of the generic form of this drug versus the reference product.Methods: 2 single-dose, test, and reference DMF products were orally administered to 24 healthy volunteers. The washout period was 28 dbetween the treatments. Monomethyl fumarate as the metabolite of DMF was analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and the method was validated. Also, the pharmacokinetic parameters were calculated for bioequivalence evaluation. Results: The analytical method was validated and linear over the range of 31.25-4000 ng/ml (R2Conclusion: The applied analytical method is selective, accurate, precise, and repeatable for the analysis of monomethyl fumarate (MMF) in plasma. Also, the bioequivalence study showedno significant difference between the pharmacokinetic parameters of these 2 products. So, the DMF test product can be claimed to be bioequivalent with the reference product |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| 9 (RLIN) |
4639 |
| Topical term or geographic name entry element |
PHARMACEUTICS |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| 9 (RLIN) |
15957 |
| Co-Author |
Sadrai, Sima |
| 773 0# - HOST ITEM ENTRY |
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| Title |
International journal of pharmacy and pharmaceutical science |
| International Standard Serial Number |
2656-0097 |
| Place, publisher, and date of publication |
Bhopal Innovare Academic Sciences Pvt Ltd |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| URL |
https://innovareacademics.in/journals/index.php/ijpps/article/view/42328/25272 |
| Link text |
Click here |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Source of classification or shelving scheme |
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| Koha item type |
Articles Abstract Database |
