№ files_lp_3_process_9_06483
File format: docx
Character count: 19123
File size: 81 KB
Formularies, batch compositions, clinical study reports, and analytical validation results of bioequivalence trials for pharmaceutical products are compiled with detailed regulatory and clinical data for submission to SAHPRA.
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
Price: 8 / 10 USD
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The file will be delivered to the email address provided at checkout within 12 hours.
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The product description is provided for reference. Actual content and formatting may differ slightly.
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:
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
Year:
2025
Region / City:
Istanbul
Topic:
Graduate Student Congress, Writing Guidelines
Document Type:
Guidelines
Organization / Institution:
Istanbul Sabahattin Zaim University, İlim Yayma Foundation
Author:
Not specified
Target Audience:
Graduate students, researchers
Period of Action:
May 14-15, 2025
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2012
Region / city:
European Union
Topic:
Ecotoxicology, Toxicology, Regulatory Standards
Document type:
Guideline
Organization / institution:
European Commission
Author:
European Commission
Target audience:
Regulatory authorities, researchers in ecotoxicology and toxicology
Period of validity:
Not specified
Date of approval:
Not specified
Date of amendments:
Not specified
Year:
2021
Region / City:
Canberra, Australia
Topic:
Obstetrics / Breech Pregnancy
Document Type:
Clinical Guideline
Organization:
Canberra Health Services
Target Audience:
Medical Officers, Midwives, Midwifery/Medical Students
Scope:
Singleton breech presentation from 35 weeks gestation
Procedures Covered:
External Cephalic Version, Elective Lower Uterine Segment Caesarean Section, Vaginal Breech Birth
References:
Term Breech Trial, RANZCOG 2021, National Blood Authority Recommendations
Attachments:
Definitions, Search Terms, Related Policies and Legislation
Year:
2026
Region / City:
Paris
Subject:
Paper submission guidelines for CIGRE Sessions
Document type:
Instruction manual
Organization:
CIGRE
Audience:
Authors of papers for CIGRE Sessions
Effective period:
Until the Paris Session 2026
Approval date:
Not specified
Modification date:
Not specified
Year:
2025
Note:
Region / City
Theme:
Business Software / Presentation Software
Document Type:
Lesson Plan
Author:
Glenda Liddell-White
Target Audience:
Students
Period of Validity:
April 14 – 18, 2025
Contextual Description:
A lesson plan for teaching students how to create and manage professional presentations using Microsoft PowerPoint.
Document type:
Evaluation form and grading rubric
Program code:
FSG604
Assessment components:
Written report, log book, oral presentation
Assessment weightage:
Written report 20%, log book 10%, oral presentation 20%
Total marks per component:
25
Assessment criteria:
Structure and quality, introduction and background, contents and findings, conclusion and recommendation, references and appendices, organization background, task and project, impact of training, question and answer
Institutional role:
Industrial training coordinator
Coordinator name:
Mohd Azizi Nawawi
Contact method:
Email submission
Intended users:
Evaluators and students undergoing industrial training
Context of use:
Industrial training assessment
Evaluation scale:
Very Weak to Very Good
Language of instruction:
English
Academic context:
Industrial training programme assessment
Year:
2023
Note:
Region / City
Subject:
HCFC Phase-Out Management Plan
Document Type:
Guide
Author:
Multilateral Fund Secretariat
Target Audience:
Governments, Implementing Agencies
Date of Revisions:
July 2023
Year:
Not specified
Region / City:
Not specified
Subject:
Education, Curriculum and Instruction
Document Type:
Academic Program
Author:
Not specified
Target Audience:
Students of Ed.D. program
Period of validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Context:
An academic program outline detailing the courses, requirements, and residency activities for students pursuing a Doctorate in Education with a concentration in Curriculum and Instruction.
Year:
2017
Region / city:
United States
Topic:
Air technical documents, archives, Japanese military documents
Document type:
Research paper
Author:
Yayoi Tsutsui
Target audience:
Researchers, historians, archivists
Date of approval:
Not specified
Date of changes:
Not specified
Description:
A reference document presenting an overview of the archival research and various sources related to captured Japanese air technical documents, with a focus on the National Air and Space Museum and other archives.
Note:
Year
Institution:
Purdue University
Author:
Jacob Brejcha, M.S.
Target Audience:
Students in COM 217, particularly those pursuing science careers
Period of validity:
Fall Semester
Year:
2023
Region / city:
West Lafayette, Indiana
Subject:
Science Communication
Document type:
Syllabus
Institution:
Purdue University
Author:
Jacob Brejcha, M.S.
Target audience:
Students enrolled in COM 217
Period of validity:
Fall semester 2023
Approval date:
2023
Date of changes:
Not specified
Year:
2023
Region / city:
England
Theme:
Safeguarding, Child Protection, Education
Document Type:
Presentation
Organization / Institution:
Schools
Author:
Not specified
Target Audience:
School staff
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
2023
Year:
2025
Region / City:
Barcelona, Spain
Theme:
Science and process related to the conference topics
Document type:
Submission Form
Organization:
EBF
Target Audience:
Researchers, scientists, and professionals in bioanalysis and related fields
Date of approval:
N/A
Date of changes:
N/A
Year:
2016
Region / City:
United States
Theme:
Nonprofit Financial Reporting
Document Type:
Accounting Standard Update
Organization / Institution:
Financial Accounting Standards Board (FASB)
Author:
Financial Accounting Standards Board (FASB)
Target Audience:
Nonprofit Entities
Period of Action:
Fiscal years beginning after December 15, 2017
Approval Date:
August 2016
Amendment Date:
Not yet determined
Year:
2001
Type of document:
Regulatory guidance
Scope:
Pharmacokinetics data reporting for nonclinical studies
Applicable region:
International (ICH)
Referenced guidelines:
M4 Organization of the Common Technical Document, M4S: The CTD — Safety and Safety Appendices
Target audience:
Pharmaceutical industry, regulatory affairs professionals
Document format:
Templates and tables for data presentation
Key topics:
Absorption, distribution, metabolism, excretion, plasma protein binding, study in pregnant or nursing animals