№ files_lp_4_process_3_090791
File format: docx Character count: 3955 File size: 20 KB
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.
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The product description is provided for reference. Actual content and formatting may differ slightly.
IBRUTINIB, Capsule 140 mg, Tablet 280 mg, Tablet 420 mg, Imbruvica®, JANSSEN-CILAG PTY LTD
Year: 2023
Region / City: Australia
Theme: Medicine, Oncology
Document Type: Submission Report
Organization / Institution: PBAC (Pharmaceutical Benefits Advisory Committee)
Author: JANSSEN-CILAG PTY LTD
Target Audience: Healthcare professionals, regulators
Period of Validity: Ongoing
Approval Date: 28 March 2023
Modification Date: December 2022
Carflizomib With and Without Ibrutinib in Frontline and Relapsed / Refractory WM (CZAR01)
Year: 2024
Region / City: Europe
Topic: Waldenstrom’s Macroglobulinemia, Treatment Approaches
Document Type: Clinical Trial Report
Author: Meletios Dimopoulos, Maria Gavriatopoulou, Efstathios Kastritis, Christian Buske
Target Audience: Medical Researchers, Oncologists, Hematologists
Study Phase: Phase II
Date of Approval: June 2024
Date of Changes: N/A
Primary Endpoint: Achievement of CR / VGPR at 12 and 24 months
Secondary Endpoints: Time to best response, time to first response, time to treatment failure, remission duration, progression free survival, cause specific survival, overall survival, safety, quality of life
Regulatory Guidance on Pharmacokinetics Data Presentation in eCTD 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
Supplementary Material: Figures S1–S4 and Table S1 on Doxorubicin and Abemaciclib Synergy and Population Pharmacokinetics
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
secukinumab mPBPK-TE-MBMA model based on IL-17 pharmacokinetics and target engagement
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
Pharmacology Multiple-Choice Questions and Explanations on Drug Metabolism, Receptor Pharmacology, and Pharmacokinetics
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
Topics: CYP3A IBRUTINIB Pharmacokinetics