№ files_lp_3_process_7_040363
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This document is a bioequivalence trial information form, detailing the submission and study protocols for bioequivalence studies including formulation composition, clinical study results, and bioanalytical validation.
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
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Year:
2023
Note:
Region / city
Subject:
Bioequivalence studies
Document type:
Checklist
Target audience:
Applicants submitting bioequivalence studies and biowaivers
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
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
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.
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
Date:
August 3, 2011
Author:
Lisa Hull
Document type:
Personal letter
Subject:
Support for Anna Stubblefield
Institutions mentioned:
Rutgers University; Essex County Superior Court
Individuals mentioned:
Anna Stubblefield; DMan; Judge Siobhan Teare
Location:
Newark, New Jersey
Related event:
Criminal trial beginning September 9, 2011
Purpose:
Request for awareness, attendance, and support
Funding information:
Defense fund contribution details
Communication medium:
Written correspondence
Jurisdiction:
Australia
Regulatory framework:
Therapeutic Goods Administration (TGA) Clinical Trial Notification scheme
Document type:
Regulatory notification form
Scope:
Clinical trials involving medicines, biologicals, medical and therapeutic devices
Trial phases covered:
Phase I–IV, bioavailability/bioequivalence, device studies
Subjects:
Human participants
Ethics oversight:
Human Research Ethics Committee (HREC)
Approving authority:
Relevant institutional authority
Geographic coverage:
Australian trial sites with optional international sites
Responsible party:
Lead Investigator
Fee responsibility:
Lead Investigator
Related institution:
La Trobe University
Submission requirement:
Completed form and ethics approval
Note:
Year
Topic:
Clinical Trials
Document Type:
Plan
Target Audience:
Study team, sponsors, and regulatory authorities
Year:
2014
Region / City:
Geneva
Topic:
Revision of TGP/8, DUS Trial Design and Data Analysis
Document Type:
Draft Document
Organization / Institution:
International Union for the Protection of New Varieties of Plants (UPOV)
Author:
UPOV Office
Target Audience:
Technical Committees, Working Parties for Vegetables, Agricultural Crops, Fruit Crops, Ornamental Plants, and others involved in plant variety protection
Period of Validity:
Ongoing (as of 2014)
Approval Date:
May 27, 2014
Date of Changes:
N/A
Note:
Year
Year:
2025
Region / City:
Eastern Region, Central Region, Western Region
Subject:
Field Trial Planning and Management
Document Type:
Meeting Minutes
Organization:
English Cocker Spaniel Club of America
Author:
Jack Glinsky, Jonathon Sims, Jeff Lusk, Barb Defalco, Paul McGagh, Mark Mercie, David Williams
Target Audience:
Members of the Field Trial Committee, Judges, Participants
Period of Effect:
2025
Approval Date:
July 15, 2025
Date of Changes:
Not specified
Year:
2025
Region / City:
Shanghai
Topic:
Arbitration, Early Determination
Document Type:
Guideline
Organization:
Shanghai International Economic and Trade Arbitration Commission (Shanghai International Arbitration Center)
Target Audience:
Parties involved in arbitration cases under SHIAC rules
Period of Validity:
Starting June 1, 2025
Approval Date:
June 1, 2025
Note:
Year
Topic:
Clinical Trial Agreement
Document Type:
Contract
Institution / Organization:
Istituto clinico Humanitas
Target Audience:
Medical, Scientific, and Research Professionals
Note:
Year
Topic:
Clinical Trials
Document Type:
Agreement Template
Organization:
Contract Research Organisation
Target Audience:
Sponsors, CROs, Clinical Trial Sites
Year:
2025
Region / City:
Lancaster, CA
Theme:
Herding Test and Trial
Document Type:
Event Announcement
Organization:
Antelope Valley Stockdog Club
Author:
Antelope Valley Stockdog Club
Target Audience:
Dog owners, participants in herding events
Period of Action:
14-16 March 2025
Approval Date:
N/A
Amendment Date:
N/A
Note:
Year
Type of Document:
Charter / Standard Operating Procedure
Study Phase:
Clinical Trial
Responsibilities:
Participant safety monitoring, data quality assessment, trial progress evaluation
Membership:
DSMB Chair, Voting Members, Independent Medical Monitor (if applicable)
Conflict of Interest Policy:
Disclosure and management of real or apparent conflicts
Meeting Requirements:
Quorum and attendance rules
Stopping Criteria:
Safety concerns and trial halting conditions
Year:
2024
Region / city:
South Sudan
Topic:
Procurement
Document Type:
Template
Organization / Institution:
South Sudan Public Procurement and Disposal of Assets Authority
Author:
South Sudan Public Procurement and Disposal of Assets Authority
Target Audience:
Procuring Entities (PEs), Bidders
Validity Period:
1 year (Trial Edition)
Approval Date:
November 2024
Date of Amendments:
None
Year:
2024
Country:
Canada
Study Type:
Phase II clinical trial
Treatment Regimen:
Bendamustine-Rituximab combination with concurrent Acalabrutinib
Participants:
62
Centers:
9
Primary Endpoint:
Combined Complete and Very Good Partial Response (CR+VGPR) rates
Secondary Endpoints:
Best overall response (BoR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), Minimal Residual Disease (MRD)
Median Age:
69
Mutation Analysis:
MYD88 89.3%, CXCR4 28.6%, TP53 1.8%
Adverse Events:
Treatment-related adverse events (TRAEs) in 53 participants, 42 Grade 3/4 during combination therapy, 15 Grade 3/4 during monotherapy
Follow-up:
Median 350 days
Data Cut-off:
June 5, 2024
Document Type:
Clinical trial report
Year:
2024
Region / City:
Gauteng / Pretoria / Johannesburg
Subject:
Legal Procedure
Document Type:
Trial Practice Note Template
Organization / Institution:
High Court of South Africa
Author:
Not specified
Target Audience:
Legal professionals, Plaintiffs, Defendants
Period of validity:
N/A
Approval Date:
N/A
Date of amendments:
N/A