Clinical Trials
Clinical Case Study - First in Human
Clinical Case Study - Randomized Cross Over Efficacy Study Metabolic Disorder
Clinical Case Study - Evaluting Abuse Potential (HAP) neuropathic pain medication
Clinical Case Study - Drug-Drug Interactions (DDI) Cardiovascular Medication
Clinical Case Study - FIH Safety and Tolerability Cannabis Extract
Clinical Case Study - 505(b)(2) Regulatory Approval, Multiple NDA-enabling Studies
ISSUE NO. 9 — Cardiac Safety Assessment in Clinical Trials
Electrocardiography (ECG) is an integral part of the new drug regulatory environment. Mandated by regulatory bodies the world over, the thorough and precise evaluation of a new drug’s cardiac effects is a critical element of new chemical entity (NCE) development. Sponsors must submit all NCEs with systemic exposure to a dedicated thorough QT (TQT) study to understand the drug’s impact on ECG parameters and determine whether the compound prolongs the QTc interval.
A positive finding of QT prolongation usually has a significant negative impact on a drug's development pathway, necessitating extensive additional ECG assessments, and potentially resulting in approval delays or even discontinuation of the program.
In Issue 9 of The Altascientist, we review:
- Electrocardiography
- Global regulations
- QT/QTc study design
- Timing of QT assessments
- A case study about a first-in-human clinical trial involving a QT assessment
Gut Health Connections to Overall Health - Part 2 of a 2-part series
Gut Health Connections to Overall Health (part 2 of 2)
In part 1 of this series, we discussed how gut bacteria, or the microbiota, affect your health, from metabolism to mood, and contribute to a number of chronic diseases.
Gut Health Connections to Overall Health - Part 1 of a 2-part series
“All Disease Begins in The Gut.” – Hippocrates
Research increasingly supports the idea that your gut bacteria are tied to your probability of intestinal disorders and other conditions, like diabetes, obesity, depression, and colon cancer. In this issue of the Altasciences blog, we offer an oversight of the research into how they are linked.
Genetic therapies – part 2 of a 2-part series
In today's blog, we focus on the advances being made in medicine that are affected or influenced by the increased understanding of the human genome.