№ lp_1_2_44483
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This document provides a checklist for bioequivalence studies and biowaivers submission, detailing requirements for regulatory compliance and study documentation.
Year: 2023
Note: Region / city
Subject: Bioequivalence studies
Document type: Checklist
Target audience: Applicants submitting bioequivalence studies and biowaivers
Price: 8 / 10 USD
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Checklist for product information - established active substance MAAs Version 1.0
Year: 2023
Region / city: United Kingdom
Topic: Product Information, Regulatory Submissions
Document Type: Checklist
Organization / Institution: Human Medicines Regulations
Note: Author
Target Audience: Applicants for MAAs
Coronavirus Disease 2019 (COVID-19) Cases in MAAs of May 20, 2020
Year: 2020
Region / city: Massachusetts, United States
Topic: COVID-19 cases
Document Type: Report
Author: Bureau of Infectious Disease and Laboratory Sciences
Target Audience: Public health officials, researchers, and general public
Period of validity: May 20, 2020
Approval Date: May 20, 2020
Date of Changes: Not specified
PRESENTATION OF BIOEQUIVALENCE TRIAL INFORMATION
Year: 2023
Region / City: Copenhagen Ø, Denmark
Theme: Bioequivalence trials
Document Type: Instructional guidelines
Organ / Institution: WHO Prequalification Team – Medicines
Author: WHO
Target Audience: Pharmaceutical companies and regulatory bodies
Effective Period: Indefinite
Approval Date: Not specified
Date of Changes: Not specified
BIOEQUIVALENCE TRIAL INFORMATION
Year: 2023
Region / City: Lagos, Nigeria
Theme: Bioequivalence trials and regulatory submission
Document Type: Instructional Guidelines
Organization: NAFDAC
Author: NAFDAC
Target Audience: Pharmaceutical companies, regulatory affairs personnel
Period of Validity: Ongoing
Approval Date: Not specified
Date of Last Update: Not specified
BIOEQUIVALENCE TRIAL INFORMATION (BTIF) General Instructions
Note: Year
Subject matter: Bioequivalence trial instructions
Document type: Instruction manual
Organization / institution: TMDA (Tanzania Medicines and Medical Devices Authority)
Target audience: Regulatory bodies, clinical researchers, pharmaceutical developers
Contextual description: Instructions for completing a bioequivalence trial information form for submission to TMDA, including details on clinical trials, formulations, and documentation requirements.
BIOEQUIVALENCE TRIAL INFORMATION FORM
Year: 2021
Region / City: South Africa
Topic: Bioequivalence Studies
Document Type: Clinical Study Report
Organization: SAHPRA
Author: Not specified
Target Audience: Regulatory authorities, pharmaceutical companies, clinical researchers
Study Period: Dates of clinical study phases and product administration not specified
Approval Date: Not specified
Amendment Date: Not specified
Presentation of Bioequivalence Trial Information
Year: Not specified
Region / City: Not specified
Subject: Bioequivalence studies and clinical trial data for pharmaceutical products
Document Type: Regulatory submission form
Organization / Institution: South African Health Products Regulatory Authority (SAHPRA)
Author / Applicant: Not specified
Target Audience: Regulatory reviewers and evaluators
Study Period: Not specified
Date of Application: Not specified
Manufacturer: Not specified
Contract Research Organisation (CRO): Not specified
Independent Ethics Committee (IEC): Not specified
Principal Investigator: Not specified
Number of Subjects: Not specified
Dosage Form: Not specified
Batch Number and Size: Not specified
Reference Product Batch Number & Expiry Date: Not specified
Pharmacokinetic Parameters: Included
Statistical Analysis: Included
Analytical Validation Methods: Included
Quality Assurance Procedures: Included
Clinical Study Site: Not specified
Topics: biowaivers MAAs bioequivalence