№ lp_1_2_36260
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Guidance document providing structured templates and instructions for reporting pharmacokinetics study data in nonclinical sections of the Common Technical Document (CTD) submissions.
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
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Document Type:
Supplementary material
Subject:
Drug synergy and population pharmacokinetic modeling
Drugs Studied:
Doxorubicin; Abemaciclib
Cell Lines:
MDA-MB-231; MDA-MB-468
Methods:
Western blot; HPLC; LC-MS/MS; Visual predictive check; Goodness-of-fit analysis
Data Type:
In vitro experimental data; Clinical pharmacokinetic data
Measurement Units:
µM; µg/mL; mg/m2; m2; hr
Sample Size:
n values ranging from 3 to 41
Referenced Publications:
1983–2018
Analytes:
Free doxorubicin; Pegylated liposomal doxorubicin; Total doxorubicin
Note:
Year
Topic:
Pharmacokinetics, Ibrutinib, CYP3A Inhibition
Document Type:
Research Paper
Authors:
Eric D. Eisenmann, Qiang Fu, Elizabeth M. Muhowski, Yan Jin, Muhammad Erfan Uddin, Dominique A. Garrison, Robert H. Weber, Jennifer Woyach, John C. Byrd, Alex Sparreboom, Sharyn D. Baker
Target Audience:
Researchers, Pharmacologists, Healthcare Professionals
Context:
A research paper analyzing the intentional modulation of ibrutinib pharmacokinetics through CYP3A inhibition, including experimental methods and data on the effects of ketoconazole and cobicistat.
Year:
2013
Model type:
mPBPK-TE-MBMA
Drug:
secukinumab
Based on:
2nd generation mPBPK-TE model for IL-17 (Cao & Jusko, JPKPD, 2013)
Author:
JLee
Data file:
IL17_mPBPK_NM_v01_LN.csv
Subroutines:
ADVAN6
Compartment description:
ABS, serum, muscle, leaky, skin, lymph, total IL17A serum, total IL17A skin
Parameters:
CL, FA, KA, L, LS, L1, L2, VP, V1, V2, VS, VL, kdegSK, kdegSE, kintSK, kintSE, BSsk, BSse, KD, sSK, s1, s2, sL
Error model:
combined additive and proportional, log-transform for serum and skin PK
Simulation:
1234 replicates, NSUBPROBLEMS=1, ONLYSIM
Output tables:
sdtab1128, patab1128, catab1001, cotab1001
Target audience:
pharmacometricians, modelers
Scope:
pharmacokinetic and target engagement predictions for secukinumab in serum and skin compartments
Subject:
Pharmacology
Field:
Medical education
Document type:
Multiple-choice question set with explanations
Topics:
Receptor pharmacology, CYP450 enzyme induction and inhibition, opioid metabolism, drug potency, half-life calculations, pharmacokinetics, phase I and phase II metabolism, volume of distribution, bioavailability
Drugs mentioned:
Verapamil, Sulphonylureas, Erythromycin, Fluconazole, Fentanyl, Codeine, Oxycodone, Hydrocodone, Aspirin, Digoxin, Atenolol, Diazepam, Phenytoin, Prilocaine, Lignocaine, Gentamycin
Biochemical systems:
Cytochrome P450 enzymes, CYP2D6, CYP3A4
Educational level:
Medical students / exam preparation
Content format:
Question and answer with explanatory notes
Language:
English
Note:
Year
Topic:
eCTD, registration dossier, Ministry of Health of Ukraine
Document Type:
Order
Organization / Institution:
Ministry of Health of Ukraine
Target Audience:
Regulatory authorities, applicants for medicinal product registration
Year:
2009
Region / city:
South Africa
Subject:
Registration of medicines
Document type:
Guideline
Organization / institution:
South African Health Products Regulatory Authority (SAHPRA)
Author:
Not specified
Target audience:
Applicants for registration of medicines
Period of validity:
Ongoing
Date of approval:
Not specified
Date of amendments:
May 2019
Version:
7
Date of implementation:
June 2011
Deadline for comment:
September 30, 2010
Year:
Not specified
Jurisdiction:
South Africa
Regulatory authority:
South African Health Products Regulatory Authority (SAHPRA)
Document type:
Regulatory validation checklist
Document format:
eCTD
Subject area:
Medicinal product variations
Product type:
Human medicinal products
Application type:
Variation application
Intended submitter:
Holder of certificate of registration
Submission scope:
Administrative, technical, and business validation
Regulatory modules referenced:
CTD Modules 1–5
Use context:
Initial and follow-up eCTD sequences
Approval status fields:
Included
Language:
English
Year:
2015
Region / City:
Thailand
Topic:
eCTD Specification, Regulatory Submission, Pharmaceutical Industry
Document Type:
Technical Specification
Organization / Institution:
Thai FDA
Author:
Thai FDA
Target Audience:
Pharmaceutical companies, regulatory professionals
Validity Period:
Ongoing
Approval Date:
01/12/2015
Date of Changes:
Not specified
Year:
2024
Region / City:
European Union
Topic:
eCTD Implementation
Document Type:
Technical Guide
Organization / Institution:
Health Level Seven (HL7)
Author:
Not specified
Target Audience:
Regulatory bodies, developers, and industry professionals involved in eCTD implementation
Effective Period:
2024
Approval Date:
March 2024
Date of Changes:
March 2024
Version:
1.2
Date:
4th of October 2024
OID:
2.16.840.1.113883.3.989.5.1.1.6.1.2
Document Change History:
2012-2024
Year:
2024
Region / City:
EU
Theme:
Electronic submission, regulatory requirements
Document Type:
Technical Guide
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Regulatory bodies, pharmaceutical industry
Effective Period:
2024 and beyond
Approval Date:
4th October 2024
Modification Date:
N/A
Year:
N/A
Region / City:
N/A
Subject:
Pharmaceutical Documentation, eCTD
Document Type:
Regulatory Guidance
Organization / Institution:
FDA
Author:
N/A
Target Audience:
Pharmaceutical Industry
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2023
Region / City:
South Africa
Topic:
eCTD validation for new registration of medicinal products
Document Type:
Template
Organization:
SAHPRA
Author:
Not specified
Target Audience:
Applicants submitting new registration applications for medicinal products in eCTD format
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Year
Topic:
Clinical Research / Protocol Development
Document Type:
Protocol Template
Organization / Institution:
DMID
Author:
DMID
Target Audience:
Clinical Researchers, Investigators
Year:
2023
Region / City:
United States
Topic:
Healthcare, Medicare, MIPS, Value Pathways
Document Type:
Guidelines
Organization:
Centers for Medicare & Medicaid Services (CMS)
Author:
Centers for Medicare & Medicaid Services (CMS)
Target Audience:
General public, healthcare professionals, clinicians
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
Not provided
Region / City:
Not specified
Topic:
Research ethics, manuscript submission
Document type:
Template
Author:
Not specified
Target audience:
Authors submitting research articles
Period of validity:
Not provided
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / city:
United States
Topic:
Merit-based Incentive Payment System (MIPS)
Document Type:
Instructions and Template
Agency / Institution:
Centers for Medicare & Medicaid Services (CMS)
Author:
Centers for Medicare & Medicaid Services (CMS)
Target Audience:
General public, healthcare professionals, and stakeholders in the Medicare program
Effective Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
Not specified
Region / City:
Cincinnati
Subject:
Social and Behavioral Sciences Research
Document Type:
Research Protocol Submission Guidelines
Institution / Organization:
University of Cincinnati
Author:
Not specified
Target Audience:
Researchers submitting to the IRB-S
Validity Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / City:
United States
Topic:
Mortgage Insurance, FHA, Real Estate
Document Type:
Official Form
Organization:
U.S. Department of Housing and Urban Development (HUD)
Author:
HUD
Target Audience:
Lenders, Mortgagees
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2021
Region / City:
United States
Topic:
Disaster Assistance
Document Type:
Supporting Statement
Organization:
Federal Emergency Management Agency (FEMA)
Author:
Federal Emergency Management Agency (FEMA)
Target Audience:
Individuals applying for disaster assistance
Period of Validity:
N/A
Approval Date:
N/A
Date of Amendments:
N/A
Year:
2025
Region / city:
N/A
Topic:
Manuscript submission guidelines
Document type:
Guidelines
Organization / institution:
Journal of Crustacean Biology
Author:
N/A
Target audience:
Authors preparing manuscripts for submission
Effective period:
N/A
Approval date:
N/A
Amendment date:
N/A