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DISCUSSION This study examined the pharmacokinetic properties and bioequivalence of 2 formulations of sodium 200 mg tablet in healthy Indian adult male subjects. 10 12-13 Our study data show that both sodium formulations the predefined bioequivalence criteria of 80 to 125 for the primary end point of Cmax and AUC. The study results revealed that the 2 formulations of sodium were similar in PK characteristics among th.

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, an anticoagulant, and , an antiseizure drug, are examples of such drugs.

The bioavailability studies are done by measuring the concentration of the drug in the plasma or blood after administration of drug following systemic protocol of studies and documented over time.

In general, bioequivalence is evaluated by comparing the bioavailability of the test, and the reference products, in crossover clinical studies on healthy subjects. The study may include the evaluation of bioavailability of products administered with, and without, food.

Possible methods for assessing bioavailability include determining drug liberation and dissolution at the administration or absorption site, determining free drug in systemic circulation, measuring pharmacologic effect or clinical response, and determining urinary excretion of the drug.

Bioequivalence is usually studied by administering dosages to subjects and measuring concentration of the drug in the blood just before and at set times after the administration. These data are then used to determine if the drugs are absorbed at the same rate.

In general, bioequivalence is assessed using three parameters namely, Cmax, tmax and AUC. Urinary excretion data may also be used if the amount excreted unchanged is significant.

Two products are considered to be bioequivalent when they are equal in the rate and extent to which the active pharmaceutical ingredient (API) becomes available at the site(s) of drug action.

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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232