Clinical Trials
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.
ISSUE NO. 7 — Understanding the Intrinsic and Extrinsic Factors that Alter Drug Exposure and Toxicity
Intrinsic factors such as age, biological sex, comorbidities, or genetics can potentially alter drug exposure, as can extrinsic factors such as concomitant drugs, supplements, the environment, and food and beverages. One of the most important factors to consider during the course of your early-phase clinical research is drug-drug interactions (DDIs), which occur when one drug alters the effect of another, either by reducing its effectiveness or elevating systemic concentrations to potentially dangerous levels—ultimately causing side effects.
In some cases, these side effects could be life-threatening, such as drops in blood pressure, irregular heartbeats, or organ damage.
In Issue 7 of The Altascientist, we delve into these factors, the importance of drug interaction studies, and how to limit adverse effects and maximize treatment response. Listen to the audiobook or download the PDF below, to learn more about:
- key factors to consider in drug development (age, biological sex, genetics, DDIs);
- examples of common DDI involving the cytochrome P450 enzyme system; and
- drug interactions and guidance for marketed drugs.
The issue also features a drug-drug interaction case study, in which the effects of two doses of a sponsor’s investigational product on the pharmacokinetics of multiple oral doses of clopidogrel, and a single dose of warfarin in healthy adult subjects were evaluated.
Up Close and Personal with Ingrid Holmes
Ingrid joined Altasciences in 2011, as Vice President of Clinical Operations at the Montreal site, a facility currently housing seven clinical units with 265 beds, and dedicated