February 2017

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Industry News

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Biosimilars

 

Industry News

Assessment of Abuse Potential of Drugs

Last month, the FDA finalized a guidance intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their drug product has abuse potential. This guidance provides recommendations to applicants who intend to submit new drug applications (NDAs) for prescription drug products that may have abuse potential. Drug products with abuse potential generally contain drug substances that have central nervous system (CNS) activity and produce euphoria (or other changes in mood), hallucinations, and effects consistent with CNS depressants or stimulants. Thus, if a drug substance is CNS-active, the new drug product containing that drug substance will likely need to undergo a thorough assessment of its abuse potential and may be subject to control under the Controlled Substances Act (CSA). We are an industry leader in the conduct of Human Abuse Liability and Substance Abuse Trials, including Abuse Deterrent Formulations, opioids (oral and nasal snorting), sedative hypnotics and stimulants. Our access to a large database of substance abusers and recreational drug users ensures rapid study enrollment and start-up.

 
VIEW THE GUIDANCE

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Do you have a question about your drug development program or a clinical trial? Get access to some of the industry's leading experts here.

Chris Ore, General Manager at Altasciences' Fargo facility

IRRITATION AND SENSITIZATION

Transdermal products have properties that may lead to skin irritation and/or sensitization. The delivery system, or the system in conjunction with the drug substance, may cause these reactions.

Chris Ore, General Manager at Altasciences' Fargo facility, and his team have worked with the vast majority of products and system types: ointments, creams, gels, sprays, transdermal systems, micro needle patches, self-administration (pump) patches, NCEs, BE, narcotics, analgesics, nicotine, CNS, corticosteroids, etc.

Click below to ask a question of Chris.

Steve Mason, General Manager Altasciences' Kansas facility

SMOKING EVALUATIONS

The FDA recently extended their authority to the regulation of all tobacco products, including e-cigarettes, cigars and hookah tobacco.

Steve Mason, General Manager, leads our team of experts at our Kansas clinical research campus equipped for the evaluation of smoking cessation, smoking, vaping, tobacco risk assessment and nicotine delivery clinical trials. Our services are designed to support specialized assessments, such as those required for the Human Laboratory Model of Smoking Behavior.

Click below to ask Steve a question.

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CANNABIS STUDY

The Therapeutic Products Directorate (TPD) of Health Canada has approved a Phase I clinical study of cannabis that we will conduct at our Montreal site; the clinical trial activities will start in the coming weeks. This will be a double-blind Phase I study to assess safety, tolerability, pharmacodynamics and pharmacokinetics of single and multiple daily ascending doses of Cannabis (Delta-9-tetrahydrocannabinol/ Cannabidiol) by smoking/inhalation in healthy male and female volunteers.

DIABETES

In recent years, regulatory agencies, such as the FDA and EMA, have outlined and recommended adoption of a risk-based approach to evaluating and mitigating immune responses to therapeutic proteins that may adversely affect their safety and efficacy. In their recommendations, both transient and persistent antibody responses should be combined to determine the overall immunogenicity of a product in a given condition.

BIOSIMILARS

Patents for several innovator biologics blockbusters, primarily monoclonal antibodies, will expire in the next few years. Driven by biopharmaceutical companies’ needs to diversify their product portfolio as well as create new revenue streams, the development of biosimilars is expected to grow substantially over the coming years. Just last month, the FDA released a draft guidance to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under section 351(k) of the Public Health Service Act (PHS Act).

Read the press release
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Alexandria

ADF 2017 — Abuse Deterrent Formulations Summit
Alexandria, Virginia
March 7-8, 2017

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SOT 2017 ANNUAL MEETING
Baltimore, Maryland
March 12-16, 2017

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Washington, District of Columbia
March 15-18, 2017

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New York, New York
March 20-23, 2017

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