№ lp_1_26714
File format: docx
Character count: 15796
File size: 85 KB
The document is a template designed for nonclinical toxicology studies involving repeated doses, providing standardized sections for reporting experimental design, results, and findings.
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
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2026
Region / City:
International
Theme:
Research Ethics
Document Type:
Standard Operating Procedure (SOP)
Organ / Institution:
ISU-IREB
Author:
ISU-IREB SOP Team
Target Audience:
Researchers, IREB Members
Period of Validity:
Ongoing
Approval Date:
2026-02-03
Date of Changes:
N/A
Year:
2026
Region / city:
N/A
Subject:
Pharmaceutical regulatory submission
Document type:
Submission guidelines
Authority / institution:
N/A
Author:
N/A
Target audience:
Applicants for pharmaceutical submissions
Validity period:
N/A
Approval date:
N/A
Amendment date:
N/A
Note:
Year
Contextual description:
A checklist for the submission of variations related to type II clinical and non-clinical changes to product information in the European market.
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
Document Type:
Regulatory guidance
Module:
2.4 Nonclinical Overview
Framework:
Common Technical Document (CTD)
Related Guideline:
M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
Note:
Related Guideline
Guidance for Industry M4S: The CTD — Safety
Subject:
Nonclinical testing strategy, pharmacology, pharmacokinetics, and toxicology
Intended Application:
Registration of pharmaceuticals for human use
Referenced Standards:
Good Laboratory Practice (GLP)
Scope:
Evaluation of pharmacologic, pharmacokinetic, toxicologic, and impurity data
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:
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
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