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  • Medicines Control Authority Of Zimbabwe Form: Evf 07 Biowaiver For Additional Strengths Application

Get Medicines Control Authority Of Zimbabwe Form: Evf 07 Biowaiver For Additional Strengths Application

Medicines Control Authority of Zimbabwe Form: EVF 07 BIOWAIVER FOR ADDITIONAL STRENGTHS APPLICATION FORM This application form is designed to facilitate information exchange between the Applicant.

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Requirements for a BCS-based biowaiver study include: a- Dissolution Test in 3 different media (in 900 ml and at 37°C) which are: Buffer pH 1.2, simulated gastric fluid without enzymes or 0.1N HCl. Buffer pH 4.5. Buffer pH 6.8 or simulated intestinal fluid without enzymes.

Bioequivalence studies are used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two pharmaceutical products are said to be bioequivalent, then they would be expected to be the same for all intents and purposes.

Products are considered to be bioequivalent, if the 90% confidence interval of difference in the average values of logarithmic parameters to be assessed between test and reference products is within the acceptable range of log(0.80) - log(1.25).

The FDA considers two products bioequivalent if the 90% CI of the relative mean Cmax, AUC(0–t) and AUC(0–∞) of the test (e.g. generic formulation) to reference (e.g. innovator brand formulation) should be within 80% to 125% in the fasting state.

In general, the generic product being considered for a biowaiver must contain the same active and inactive ingredients (Q1) in the same dosage form and concentration (Q2) and have the same pH and physico-chemical characteristics (Q3) as an approved RLNAD.

Products are considered to be bioequivalent, if the 90% confidence interval of difference in the average values of logarithmic parameters to be assessed between test and reference products is within the acceptable range of log(0.80) - log(1.25).

A biowaiver is applicable when the drug substance(s) in test and reference products are identical. A biowaiver may also be applicable if test and reference products contain different salts provided that both belong to BCS Class I (high solubility and high permeability).

The biowaiver can be defined as the acceptance for regulatory purposes, of the exemption or replacement of in vivo bioequivalence studies and bioavailability by in vitro assays when they are able to replace the in vivo assay reliably (Storpirtis, Gai, 2009.

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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