ISSUE NO. 3 — Assessing Human Abuse Potential to Limit the Misuse and Abuse of Prescription Drugs
Originally published June 2018 / Updated April 2022
Prescription drugs, including opioid analgesics, are an important component of modern pain management; however, along with their euphoric effects comes an increased possibility of misuse and abuse—all of which can lead to addiction, overdose, or death.
The FDA has undertaken many efforts to help clinicians
manage this widespread issue by instating guidelines
to better understand the abuse potential of new
drugs, and ensure drugs currently on the market are less likely to be abused through the use of abuse-deterrent formulations (ADFs). The FDA guidance, Assessment of Abuse Potential of Drugs, states that a broad range of CNS drugs require human abuse potential (HAP) studies, also known as human abuse liability (HAL) studies, to evaluate the abuse liability of drugs in development, and to determine the relative risk of abuse before a drug comes to market.
In Issue 3 of The Altascientist, we look at the intricacies and key considerations involved in conducting these sensitive HAP studies, including:
- FDA’s steps to limit the misuse and abuse of prescription drugs
- human abuse potential study solutions
- study design and protocol
- a case study
IBS? Don’t Despair – There are Options!
IBS is the name doctors have given to conditions characterized by cramp like abdominal pains, bloating and bouts of diarrhea and/or constipation. According to an article in Nature, it affects hundreds of millions of people — around 11% of the global population has IBS, with a higher prevalence in North America. As a result, there is a significant need for treatments.
As part of Irritable Bowel Syndrome (IBS) awareness month, we wanted to provide you with insight into potential IBS treatments.
Patient Centricity — taking care of our most valuable asset!
“Patient centricity” is the process of designing a service or solution around the patient; more specifically, it is collectively defined as “Putting the patient fi
Because who Doesn’t Love a Quiz!
ISSUE NO. 2 — Revolutionizing Traditional Medicine With Cannabis-based Medicinal Products
Cannabis, one of the oldest and most commonly used drugs in the world, is derived from the cannabis sativa plant and contains hundreds of active ingredients. These include the most abundant active constituents, tetrahydrocannabinol (THC), which is the primary psychoactive component of cannabis, and cannabidiol (CBD) which has therapeutic effects but less psychoactivity.
Research has shown that these constituents interact with various systems in the body where cannabinoid receptors are located, leading to a range of therapeutic effects within the central nervous system and its periphery.
Though it has become difficult to conduct clinical research involving cannabis, Canada became the first country in the G20 to introduce a legal framework regulating the use of cannabis by adults for non-medical purposes, creating a large-scale natural experiment that the world continues to study.
In Issue 2 of The Altascientist, we explore the science, therapeutic potential, and regulatory considerations for cannabis-based medicinal products, including:
- Supporting clinical facts and research;
- Altasciences’ experience and innovative approach to cannabinoid studies; and
- a case study on the safety and tolerability of the first cannabis extract developed for regulatory submission.
Will Biosimilars Replace Biologics?
Biologic drugs came on the market with the production of
ISSUE NO. 1 — FDA Guidance Ensures New Drugs Are Studied for Their Potential to Impair Driving Ability
Reducing the incidence of motor vehicle accidents (MVAs) caused by drug-impaired driving is a public health priority. With more than 20,000 FDA-approved drugs on the market, many containing psychoactive or sedative ingredients, systematically identifying those that may impair driving is critical for safe and effective drug development.
The FDA guidance emphasizes pharmacological/toxicological, epidemiological, and behavioral assessments to determine potential drug-related driving impairment. Early trials previously relied on self-reported adverse cognitive effects, but the FDA now mandates direct measurement to ensure accurate evaluation.
The inclusion of these assessments represents a dramatic shift in the design of early-phase studies as most only assessed self-reported adverse events related to cognition, while the guidance requires direct measurement of the effects.
In Issue 1 of The Altascientist, we look into the importance of evaluating drug effects on driving ability, including:
- Driving Simulation Testing and CNS Side Effect Specificity
- Cognitive Studies With State-of-the-Art Driving Simulator
- Regulatory Recommendations and Requirements
- Case Studies
Development of an Affinity Capture - LC-MS/MS Assay for the Quantitation of Adalimumab in Human Plasma using BioBA Sample Preparation Kit
A Novel Strategy for the In-Process Stabilization of N-Oxide Metabolites in Hemolyzed Plasma Determined by LC-MS/MS
The Application of Research Grade MetabolitePilot™ Software for the Determination of Exenatide Catabolites Using HRAM With SWATH Acquisition