Metabolic/Endocrine Archives - Insights From Our Labs to Yours

Quantitative Whole Body Autoradiography (QWBA): Your Questions Answered

by Labcorp Drug Developmentupdated on Thursday, June 3, 2021Monday, March 22, 2021

QWBA helps characterize the distribution of a drug within the body and provides vital metabolic information to inform your preclinical drug development program. Here we gain advice from two experienced study leaders on common QWBA questions and challenges.

Are you the 33 percent? The National Kidney Foundation wants to know, and help

by Barbara S. Gillespie, MD, MMS, FASNupdated on Monday, June 7, 2021Monday, March 23, 2020

They are not something most of us think about until something goes wrong. They filter 53 gallons of blood per day, remove toxins and excess volume from your blood, and help control other things like blood pressure and hemoglobin counts. They are our kidneys: two fist-sized bean-shaped organs that keep …

Expediting SEND datasets for an international regulatory submission

by Labcorp Drug Developmentupdated on Monday, June 7, 2021Thursday, February 20, 2020

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 us first started in 2014, the strength and …

Building awareness with National Diabetes Month and new T2DM treatment guidelines

by Barry J. Goldstein, MD, PhD, FACEupdated on Monday, June 7, 2021Tuesday, November 13, 2018

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

by Barbara S. Gillespie, MD, MMS, FASNupdated on Monday, June 7, 2021Thursday, October 4, 2018

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

by Dan Albaugh, MS, and Josh Fohey, BSupdated on Tuesday, June 2, 2020Thursday, August 9, 2018

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 …

Population PK/PD analysis: what, why, how and when

by Yali Zhu, MS and Xiaoyan Yang, Ph.D.updated on Monday, June 7, 2021Wednesday, July 11, 2018

Implementing population modeling, commonly called Pop PK/PD, for your pharmacokinetic (PK) or pharmacokinetic/pharmacodynamics (PK/PD) analysis is an essential tool of the drug development process and, in some demographics (like infants), a necessity.

Adjudicating Cardiovascular Endpoints in Diabetic Kidney Disease Studies

by Catherine A. Tyner, MA, MFA, ABD and Michael Cressman, D.O.updated on Monday, February 17, 2020Thursday, September 14, 2017

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 …

The Current Status of Clinical Biomarkers for Diabetic Kidney Disease Progression

by Labcorp Drug Developmentupdated on Thursday, December 17, 2020Thursday, August 31, 2017

Of the 422 million people in the world with type 1 and 2 diabetes, 20-30% will develop diabetic nephropathy, also called diabetic kidney disease (DKD) – the leading cause of renal failure in the western world1. From the perspective of drug developers, testing new therapies to prevent, treat or reverse this …

Charting a Regulatory Course for Diabetic Kidney Disease Treatment

by Richard Williams, PhD, JDupdated on Monday, February 17, 2020Thursday, August 24, 2017

As the diabetic epidemic grows, so does the prevalence of diabetic kidney disease (DKD), a frequent complication of both type 1 and 2 diabetes. Diabetic nephropathy is the leading cause of end-stage renal disease, and despite its global health burden and increased prevalence, no specific regulatory guidelines exist for developing …