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Registerclinical trials/ BE studies for locally acting drugs [Regulatives / Guidelines]
Dear Mr.Jegankm,
You need to conduct single dose, two way, cross over invivo study to show bioequivalence for Sulfasalazine Gastro-resistant Tablets 500 mg.
Since, the concentration obtained after the oral administration of Sulfasalazine 500 mg tablets will be too low due to minimal systemic absorption, it is permissible to administer more than one 500 mg tablets (upto four 500 mg tablets) to obtain adequate plasma concentration for the pharmacokinetic analytes (Sulfasalazine, and the metabolites sulfapyridine and 5-Aminosalicylic -ASA) acid (mesalamine) in plasma.
Bioequivalence will be based on Sulfasalazine as well as 5-Aminosalicylic acid.
For Docusate sodium 100mg soft gelatin capsules, it is preferable to conduct a Pharmacodynamic study.
You need to conduct single dose, two way, cross over invivo study to show bioequivalence for Sulfasalazine Gastro-resistant Tablets 500 mg.
Since, the concentration obtained after the oral administration of Sulfasalazine 500 mg tablets will be too low due to minimal systemic absorption, it is permissible to administer more than one 500 mg tablets (upto four 500 mg tablets) to obtain adequate plasma concentration for the pharmacokinetic analytes (Sulfasalazine, and the metabolites sulfapyridine and 5-Aminosalicylic -ASA) acid (mesalamine) in plasma.
Bioequivalence will be based on Sulfasalazine as well as 5-Aminosalicylic acid.
For Docusate sodium 100mg soft gelatin capsules, it is preferable to conduct a Pharmacodynamic study.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Complete thread:
- clinical trials/ BE studies for locally acting drugs jagankm 2012-01-25 11:26 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- clinical trials/ BE studies for locally acting drugsdrgunasakaran1 2012-01-31 18:42
- clinical trials/ BE studies for locally acting drugs Ohlbe 2012-01-31 19:01
- clinical trials/ BE studies for locally acting drugs jagankm 2012-02-06 12:00
- clinical trials/ BE studies for locally acting drugs Tina 2013-09-16 18:10
- clinical trials/ BE studies for locally acting drugs jagankm 2012-02-06 12:00
- clinical trials/ BE studies for locally acting drugs Tina 2013-09-19 09:45
- clinical trials/ BE studies for locally acting drugs Ohlbe 2012-01-31 19:01
- clinical trials/ BE studies for locally acting drugsdrgunasakaran1 2012-01-31 18:42
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