Clinical Trials
Pain – is it all in your head?
Pain is a fascinating phenomenon, acting as a physiological warning system that alerts us of potential dangers in our environment.
ISSUE NO. 4 — Key Considerations for Biosimilar Clinical Pharmacology Studies
Biologics have become the fastest-growing class of therapeutic compounds, with seven of the top-10 selling drugs in 2023 being biologics, each exceeding sales of $10 billion USD. In 2022, biosimilars accounted for 13.7% of all spending on biologics, compared with the 8.9% in 2021.
Biologics have provided treatment options for people who suffer from some of the most serious medical conditions, such as cancer and genetic disorders.
A biosimilar is a copy of a biologic medicine that is similar, but not identical, to the original medicine. It enters the market subsequent to the patent expiration of a previously authorized version of a biologic. A biosimilar is approved only after showing that it is “highly similar” to an approved biological product, known as the reference product, in terms of structure, purity, potency, safety, pharmacokinetics, and in many cases, efficacy, with allowable minor differences.
In Issue 4 of The Altascientist, learn about the growing interest of biosimilars, and key considerations in pharmacokinetic (PK) studies, as well as:
- The rise of the biosimilar market
- The regulatory landscape
- How Altasciences puts biosimilars to the test
- Altasciences’ expertise in bioanalysis
- Key considerations for biosimilar clinical pharmacology studies
- Ensuring the continued success of biosimilar programs
Considerations and Study Challenges for Biosimilars
Early awareness of study challenges is crucial in running a successful early-phase biosimilar development program, and certain considerations must be taken into account before beginning a study.
Topical and Transdermal – Getting Under Your Skin
The skin is the largest organ of the human body, measuring 22 square feet, on average.
WHAT IT TAKES — Central Nervous System (CNS) Clinical Trials
Biopharmaceutical companies developing new CNS products can face special obstacles.
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
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.
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
Randomized comparative bioavailability of a novel 3D printed fast melt formulation of levetiracetam following the administration of a single 1000 mg dose to healthy human volunteers under fasting and fed conditions