Expediting SEND Datasets for an International Regulatory Submission

A case study with Peg Biomedical Co., Ltd Peg Biomedical Co., Ltd. (Peg Bio), is a Suzhou, China-based biopharmaceutical company specialized in developing innovative medicines for metabolic diseases including type 2 diabetes, obesity, and non-alcoholic hepatitis.   While business between Peg Bio and Covance first started in 2014, the strength and …

Building Awareness with National Diabetes Month and New T2DM Treatment Guidelines

Coinciding with National Diabetes Month is the recent publication, Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), which contains the most up-to-date, impactful set of new treatment guidelines for patients with …

Progress in Treating Chronic Kidney Disease Patients with Cardiovascular Disease: Kidney Health Initiative Develops Clinical Research Recommendations

Throughout the world, kidney disease is far more common than most people realize. It’s not a stretch to call it a “hidden epidemic,” as the number of people living with kidney disease (850 million) is roughly twice that of those living with diabetes.(1) The health issue presented by chronic kidney disease (CKD) …

Our Polypharmacy State: Understanding Drug-Drug Interactions (DDIs) in the Drug Development Process

Updated 2020. The FDA has now approved the DDI regulations. Below is the article as originally published. In 2018 the FDA and several other regulatory bodies are expected to enact and enforce more laws related to the requirements for nonclinical drug-drug interaction (DDI) studies prior to an IND. A key …

Diabetic Kidney Disease Covance Blog

Adjudicating Cardiovascular Endpoints in Diabetic Kidney Disease Studies

Diabetic kidney disease (DKD) patients have an increased cardiovascular (CV) risk in addition to their increased risk of progression to end-stage renal disease. Recognizing that the FDA and other regulatory agencies have great interest in both the CV and renal safety and efficacy of compounds under development, pharmaceutical companies should …

Diabetic Kidney Disease Studies

Leveraging Real-World Patient Data to Support Recruitment in Diabetic Kidney Disease Studies

Practicing physicians frequently obtain laboratory assessments of kidney function in their routine management of patients with diabetes. Two tests that are commonly performed are the estimated glomerular filtration rate (eGFR) and the urinary albumin to creatinine ratio (ACR). Results of these tests are often used to determine patient eligibility for …