Objective: A male health outcomes researcher, age 55 – 65, with BMI ≥ 27 kg/m2, but without type 2 diabetes, took compounded tirzepatide 7.5 mg/week therapy with a goal of losing 10% of body weight over approximately four weeks and restoring BMI ≤ 25 kg/m2. This study was also intended to offer a more sophisticated […]
Archive for the ‘Regulatory Medical Writing’ Category
Compounded Tirzepatide Therapy for Weight Loss: A Health Outcomes Researcher’s Perspective
Posted by Michael A. S. Guth on June 23rd, 2024
Posted in Regulatory Medical Writing 
Tags: agonist, GIP, GLP-1, injectable drug, Tirzepatide, weight loss 
Comments Off on Compounded Tirzepatide Therapy for Weight Loss: A Health Outcomes Researcher’s PerspectiveCurrent research on drug used for obesity and weight loss
Posted by Michael A. S. Guth on April 18th, 2024
In the obesity landscape, glucagoon-like peptide-1 (GLP-1) agonists dominate the weight loss market. Amylin agonists work differently from GLP-1s but may be able to induce similar weight loss with fewer adverse events. My client wanted to understand the molecular differences between various amylin assets and their hypothetical impacts on the efficacy / adverse event profile. […]
Posted in Regulatory Medical Writing Comments Off on Current research on drug used for obesity and weight lossCan Proteins be Modified to Fight Diseases and Cancer?
Posted by Michael A. S. Guth on January 4th, 2024
Proteolysis Targeting Chimera
Posted in Regulatory Medical Writing Tags: Disease-Causing Proteins, monoclonal antibodies (mAbs), NF-κB, PROTAC, Proteolysis Targeting Chimera, Proteolysis Targeting Chimerics, small molecule inhibitors (SMIs), transcription factors, Ubiquitin-Proteasome System (UPS) Comments Off on Can Proteins be Modified to Fight Diseases and Cancer?Beautiful Reflection on Water House by a Lake
Posted by Michael A. S. Guth on September 4th, 2022
Pictures shot by Heather Cox Richardson while kayaking.
Clinical Evaluation Report (CER) Medical Writer
Posted by Michael A. S. Guth on March 15th, 2020
Perform Clinical Evaluations and write/update Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs) in compliance with the European Union (EU) Medical Device Regulation (MDR). Perform Literature Reviews using PubMed, Embase, Cochrane Library, and similar databases. Interpret the current, new, and changing requirements for clinical research—including heightened restrictions on product equivalency—to ensure the proper clinical […]
Posted in Featured, Regulatory Medical Writing Comments Off on Clinical Evaluation Report (CER) Medical WriterCMS Shared Savings Program
Posted by Michael A. S. Guth on October 20th, 2018
Background The Affordable Care Act (ACA) included provisions to expand value-based purchasing; broaden quality reporting; improve the level of performance feedback available to providers; and create incentives to enhance quality, improve beneficiary outcomes, and increase the value of care. Confidential physician feedback reporting was initially implemented under Section 131 of the Medicare Improvements for Patients […]
Posted in Featured, Regulatory Medical Writing Tags: accountable care organization, CMS, Medicare, physician fee schedule, risk sharing, shared savings program Comments Off on CMS Shared Savings ProgramDeclining incidence of major diseases: heart disease, hip fractures, colon cancer, etc.
Posted by Michael A. S. Guth on October 18th, 2018
“Screening, they say, is only part of the story. “The magnitude of the changes alone suggests that other factors must be involved,” they wrote. None of the studies showing the effect of increased screening for colon cancer have indicated a 50 percent reduction in mortality, they wrote, “nor have trials for screening for any type […]
Posted in Featured, Regulatory Medical Writing Comments Off on Declining incidence of major diseases: heart disease, hip fractures, colon cancer, etc.