№ lp_1_2_36261
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This document provides detailed regulatory guidance and templates for the submission of toxicology data as part of the Common Technical Document (CTD) for pharmaceutical registration.
Year:
2023
Region / City:
United States
Topic:
Pharmaceutical Research, Toxicology, Regulatory Guidance
Document Type:
Guidance
Organization / Institution:
U.S. Food and Drug Administration (FDA)
Author:
FDA
Target Audience:
Pharmaceutical Industry, Regulatory Professionals
Period of Action:
Ongoing
Approval Date:
2023
Modification Date:
N/A
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Year:
2021
Region / city:
N/A
Subject area:
Toxicology
Document type:
Template
Author:
BioCelerate
Target audience:
Researchers, regulatory professionals
Period of validity:
N/A
Approval date:
N/A
Amendment date:
N/A
Note:
Year
Agency / Organization:
Colorado Bureau of Investigation
Year:
2024-2025
Region / City:
Tucson, Arizona
Topic:
Pharmacology and Toxicology Graduate Program
Document Type:
Handbook
Institution:
The University of Arizona
Author:
Not specified
Target Audience:
Graduate students in Pharmacology and Toxicology
Period of Validity:
2024-2025
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
N/A
Region / City:
N/A
Subject:
Toxicology Study Plan/Protocol
Document Type:
Template
Organization / Institution:
BioCelerate
Author:
N/A
Target Audience:
Researchers, Sponsors, and CROs involved in nonclinical studies
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Subject area:
Forensic science
Document type:
Educational assessment
Format:
Multiple-choice and true/false questions
Topics covered:
Fingerprints, DNA and mitochondrial DNA, hair analysis, forensic odontology, toxicology, medical examination
Intended audience:
Students
Discipline:
Criminal justice and forensic studies
Language:
English
Year:
2024-2025
Region / City:
Chapel Hill, North Carolina
Topic:
Toxicology and Environmental Medicine
Document Type:
Graduate Student Handbook
Organization / Institution:
University of North Carolina at Chapel Hill
Author:
CiTEM Leadership
Target Audience:
Graduate students in Toxicology and Environmental Medicine
Period of Validity:
2024-2025 Academic Year
Approval Date:
2024
Date of Changes:
Spring 2024
Year:
2019
Region / City:
N/A
Topic:
Dermal Toxicology, Officer Roles, Society of Toxicology
Document Type:
Roles and Responsibilities
Organization / Institution:
Society of Toxicology
Author:
N/A
Target Audience:
DTSS Officers, Society of Toxicology Members
Period of Validity:
Ongoing
Approval Date:
N/A
Date of Changes:
N/A
Subject:
Drug identification and toxicology
Type of document:
Educational worksheet
Topic:
Controlled substances and toxicology
Content focus:
Drug classification, toxic substances, testing methods, and alcohol metabolism
Legal reference:
Federal controlled substance schedules
Educational level:
Secondary education
Format:
Question-based review
Key areas:
Presumptive and confirmatory testing, drug categories, poisoning types, alcohol analysis
Course Code:
TOX 503
Credits:
1 Credit
Semester:
Fall 2016
Course Title:
Skin Toxicology and the Environment
Type of Document:
Course Syllabus
Academic Level:
Graduate
Course Format:
Lectures and Journal Article Reviews
Class Time:
Thursdays 1:30–2:30 PM
Location:
Conference Room 4-8820
Prerequisites:
None
Recommended Background Courses:
IND409 Cell Biology; MBI 473 Immunology; TOX592 Immunotoxicology; PTH509 Pathways of Human Disease
Assessment Method:
Attendance (50%); Class Participation (25%); Homework (25%)
Main Topics:
Skin Structure and Function; Skin Penetration; Skin and the Environment; Skin Care and Cosmeceuticals
Instructional Activities:
Lectures; Journal Reviews; Student Presentations; Computational Examples
Year of Birth:
Not specified
Institution:
North Carolina State University
Department:
Biological Sciences and Toxicology Program
Position:
Goodnight Distinguished Chair in Molecular Toxicology, Professor
Education:
B.S. in Biology, University of Massachusetts Dartmouth, 1977; Ph.D. in Toxicology, University of Michigan, 1984; Postdoctoral Fellow, Roche Institute of Molecular Biology, 1984–1986
Research Interests:
Keratinocyte and cutaneous biology, skin cancer, gene-environment interactions, apoptosis regulation, C/EBP transcription factors, long noncoding RNAs
Employment Periods:
1986–Present
Professional Societies:
American Association for Cancer Research, Society of Toxicology, North Carolina Regional Chapter of the Society of Toxicology
Honors:
Goodnight Distinguished Chair in Molecular Toxicology (2019), William Neal Reynolds Distinguished Professor (2012–2019), Alumni Outstanding Research Award (2017)
Editorial and Organizational Roles:
Member of editorial boards, symposium organizer, conference co-chair, program review member at multiple institutions
Contact:
[email protected], Raleigh, NC, USA
Document Type:
Curriculum Vitae
Target Audience:
Academic and professional peers in toxicology and related biomedical sciences
Source Context:
Academic curriculum vitae detailing education, professional appointments, research focus, honors, society memberships, and service activities in toxicology and molecular biology
Year:
2025
Region / City:
Dorset, BCP Council
Theme:
Pharmaceutical Services, Health Needs Assessment
Document Type:
Draft Report
Organization:
Public Health Dorset
Author:
Jane Horne, Lee Robertson, Wilson Otitonaiye, Rohan Mongru, Fiona Arnold, Louise Bate
Target Audience:
Health professionals, policymakers, local authorities
Period of Validity:
2025-2028
Approval Date:
Draft version, ongoing review
Date of Last Update:
04/06/2025
Context:
This document provides a comprehensive pharmaceutical needs assessment for the Dorset area, focusing on the supply, demand, and gaps in pharmaceutical services over the period 2025-2028.
Year:
2014
Region / City:
Global
Topic:
Pharmaceutical Product Prequalification
Document Type:
Guideline
Organization / Institution:
World Health Organization (WHO)
Author:
World Health Organization
Target Audience:
Pharmaceutical manufacturers, regulatory bodies
Effective Period:
Not specified
Approval Date:
2014
Modification Date:
Not specified
Note:
Year
Topic:
Pharmaceutical product, regulatory approval, prequalification
Document type:
Template
Organization / institution:
WHO
Target audience:
Regulatory authorities, pharmaceutical manufacturers
Year:
2023
Region / City:
United Kingdom
Topic:
Pharmaceutical guidance
Document type:
Consultation response
Organization:
Royal Pharmaceutical Society
Author:
Royal Pharmaceutical Society
Target audience:
Pharmacy professionals, regulatory bodies, pharmacy service owners
Action period:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
HDA Standard Pharmaceutical (Rx-only) Product and Medical Device Information Short Form Instructions
Note:
Year
Theme:
Pharmaceutical products, Medical devices
Document type:
Instructions, Form
Organization / Institution:
HDA
Target audience:
Distributors, Manufacturers, Supply chain professionals
Document type:
Regulatory template appendix
Subject:
Quality information summary for finished pharmaceutical products and vaccines
Procedure:
Reference SRA collaborative procedure
Regulatory framework:
WHO Guidelines on submission of documentation for prequalification
Issuing organization:
World Health Organization
Series:
WHO Technical Report Series
Series number:
No. 1010
Year:
2018
Scope:
Pharmaceutical products and vaccines approved by stringent regulatory authorities
Intended use:
National registration under the SRA collaborative procedure
Confidentiality status:
Includes confidential quality information
Approval basis:
Information as approved by the reference SRA
Change management:
Revision required upon approved variations affecting QIS-SRA (crp)
Organization:
World Health Organization; South African Health Products Regulatory Authority
Document type:
Regulatory guideline
Subject area:
Pharmaceutical quality documentation
Scope:
Multisource (generic) finished pharmaceutical products and active pharmaceutical ingredients
Applicable products:
Human medicines; biologics; veterinary medicines
Regulatory references:
WHO TRS 970 Annex 6; VICH guidelines; European Pharmacopoeia; USP; BP
Geographical applicability:
International; South Africa
Related regulatory procedures:
API Prequalification; CEP; APIMF; product dossier submission
Content focus:
Quality data requirements; labelling and product information; drug substance characterization
Intended users:
Marketing authorization applicants; regulatory assessors
Year:
2021
Region / City:
United States
Topic:
Pharmaceutical and Medical Device Product Information
Document Type:
Instructional Form
Organization / Institution:
Health Distribution Alliance (HDA)
Author:
Health Distribution Alliance
Target Audience:
Pharmaceutical distributors, medical device manufacturers, suppliers
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
2021
Year:
2023
Region / City:
Falkirk
Theme:
Health & Social Care, Pharmacy, Medication Management
Document Type:
Policy
Organization:
Falkirk Health & Social Care Partnership
Author:
Not specified
Target Audience:
Community pharmacies, care at home providers, healthcare professionals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2022
Region / city:
Great Britain
Topic:
Remote hearings, Pharmacy, Patient safety
Document type:
Response to consultation
Organization:
Royal Pharmaceutical Society
Author:
Jonathan Lloyd Jones
Target audience:
General Pharmaceutical Council, Pharmacy professionals, Stakeholders
Validity period:
N/A
Approval date:
February 7, 2022
Amendment date:
N/A