Abstract
This mini-review describes the Chemistry, Manufacturing and Control activities associated with the manufacture of [14C]-labeled drug substance and subsequent drug compounding activities to generate clinical trial material utilized in human absorption, distribution, metabolism, and excretion clinical studies. Due to the unstable nature and increased decomposition rates observed with [14C]-labeled compounds, the manufacture, testing, release, formulation, and regulatory filings are uniquely challenging. A case study of the cardiac myosin activator AMG 423 (omecamtiv mercarbil), utilized in a dual oral/intravenous infusion clinical study is presented.
Keywords: Chemistry, Manufacturing and Control (CMC), current Good Manufacturing Practice (cGMP), [14C]-Labeled Drug, Omecamtiv Mercarbil, AMG 423, human Absorption, Distribution, Metabolism, and Excretion (hADME), ICH Guidance, FDA Regulations.
Current Pharmaceutical Design
Title:Manufacturing of [14C]-Labeled Drug Substance and Drug Product Utilized in Clinical Research: A Case Study of Omecamtiv Mecarbil
Volume: 22 Issue: 5
Author(s): Scott W. Roberts, Jeroen M. Bezemer, Michael T. Kennedy, Tiffany L. Correll, Raju Subramanian and Shawn D. Walker
Affiliation:
Keywords: Chemistry, Manufacturing and Control (CMC), current Good Manufacturing Practice (cGMP), [14C]-Labeled Drug, Omecamtiv Mercarbil, AMG 423, human Absorption, Distribution, Metabolism, and Excretion (hADME), ICH Guidance, FDA Regulations.
Abstract: This mini-review describes the Chemistry, Manufacturing and Control activities associated with the manufacture of [14C]-labeled drug substance and subsequent drug compounding activities to generate clinical trial material utilized in human absorption, distribution, metabolism, and excretion clinical studies. Due to the unstable nature and increased decomposition rates observed with [14C]-labeled compounds, the manufacture, testing, release, formulation, and regulatory filings are uniquely challenging. A case study of the cardiac myosin activator AMG 423 (omecamtiv mercarbil), utilized in a dual oral/intravenous infusion clinical study is presented.
Export Options
About this article
Cite this article as:
Roberts W. Scott, Bezemer M. Jeroen, Kennedy T. Michael, Correll L. Tiffany, Subramanian Raju and Walker D. Shawn, Manufacturing of [14C]-Labeled Drug Substance and Drug Product Utilized in Clinical Research: A Case Study of Omecamtiv Mecarbil, Current Pharmaceutical Design 2016; 22 (5) . https://dx.doi.org/10.2174/1381612822666151228104826
DOI https://dx.doi.org/10.2174/1381612822666151228104826 |
Print ISSN 1381-6128 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4286 |
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
- Announcements
Related Articles
-
Evaluation of a Standardized Protocol Using Lepirudin or Argatroban for Heparin-Induced Thrombocytopenia
Cardiovascular & Hematological Agents in Medicinal Chemistry In silico Prediction of Drug Metabolism by P450
Current Drug Metabolism Knockdown of H19 Enhances Differentiation Capacity to Epidermis of Parthenogenetic Embryonic Stem Cells
Current Molecular Medicine Telephone Follow-up of Older People After Hospital Admissions
Current Aging Science Endovascular Repair of Thoracic Aortic Aneurysms
Recent Patents on Cardiovascular Drug Discovery Aging Related Changes in Mixed Basal Saliva Concentration of Sodium, Potassium and Chloride in Healthy Non Medicated Humans
Current Aging Science Clinical Approaches Toward Tumor Angiogenesis: Past, Present and Future
Current Pharmaceutical Design Emerging Roles of P2X Receptors in Cancer
Current Medicinal Chemistry A Novel Approach to Anticancer Therapies: Peroxisome Proliferator Activator-Receptor-γ as a New Target Therapy in the Treatment of Human Urological Cancer
Endocrine, Metabolic & Immune Disorders - Drug Targets Canonical Matches of Human MicroRNAs with mRNAs: A Broad Matrix of Position and Size
MicroRNA Cardiovascular Benefit of SGLT2 Inhibitors in the Therapeutics of Diabetes Mellitus: A Close Look beyond the Horizon
Current Drug Targets The Involvement of Lysosomes in Myocardial Aging and Disease
Current Cardiology Reviews Are Calcium Channel Blockers First-Line Drugs for the Treatment of Hypertension and Cardiovascular Disease?
Current Hypertension Reviews The Emerging Role of microRNA in Stroke
Current Topics in Medicinal Chemistry Selective Modulation of Aβ42 Production in Alzheimers Disease: Non-Steroidal Anti-Inflammatory Drugs and Beyond
Current Pharmaceutical Design Review on Patents for Ubiquitin-Proteasome Inhibitor as Medical Advance in Major Human Diseases
Recent Patents on Biomedical Engineering (Discontinued) Gender Disparities on Access to Care and Coronary Disease Management
Current Pharmaceutical Design Clinical Grade Stem Cell Culture
Recent Patents on Regenerative Medicine Overview of Proteasome Inhibitor-Based Anti-cancer Therapies: Perspective on Bortezomib and Second Generation Proteasome Inhibitors versus Future Generation Inhibitors of Ubiquitin-Proteasome System
Current Cancer Drug Targets Role of Oxidative-Nitrosative Stress and Downstream Pathways in Various Forms of Cardiomyopathy and Heart Failure
Current Vascular Pharmacology