January 2017

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Industry News

Safety Testing of Drug Metabolites Guidance for Industry

Last November, the FDA published a guidance to provide ‘recommendations to the industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. The safety of drug metabolites may need to be determined in nonclinical studies because these metabolites are either identified only in humans or are present at disproportionately higher levels in humans than in any of the animal species used during standard nonclinical toxicology testing. This guidance applies to small molecule nonbiologic drug products. This guidance does not apply to some cancer therapies where a risk-benefit assessment is considered. This guidance supersedes the guidance of the same name published in February 2008.’

 
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.

Graham Wood, PhD, Executive Vice President, Phase I Clinical Development

PAIN MODELS

Dr. Graham Wood, PhD, Executive Vice President, Phase I Clinical Development, offers great insight into the different pain models used to assess pain tolerance following multi-dose treatment as per the FDA guidance.

Click below to find out how we can help or to ask a question of Dr. Wood.

Dr. Martin Kankam, MD, PhD, MPH

EARLY CARDIAC SAFETY

Dr. Martin Kankam, MD, PhD, MPH, and our team of experts are well positioned to support both the classic thorough QT studies and the new early precision QT studies. Our Montreal and Kansas sites are iCardiac certified.

Click below to find out more or to ask Dr. Kankam a question.

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Peptide Catabolism

In his latest blog, Jeff Plomley, Senior Scientist, provides an overview of the key features of the research grade version of MetabolitePilotTM and shares some initial data from the determination of Exenatide catabolites formed in-vitro, as well as surveys other reports regarding the implementation of this software for tackling the challenges associated with peptide/protein catabolism.

FDA Audits Fargo Facility

Last week, Algorithme Pharma USA was inspected by the US FDA and was informed by the regulator that ‘zero 483 observations’ were issued. This was a routine inspection by the US FDA and the first FDA audit for Altasciences’ Fargo facility which opened its doors two years ago. We are proud of our team’s hard work and dedication to data quality and integrity.

NATIONAL PHARMACIST DAY

On January 12 every year, we take time to recognize our pharmacists. Our pharmacists have extensive knowledge and experience in preparing and dosing studies via oral, sublingual, intranasal and parenteral routes. They play a key role in supporting early development needs for investigational product preparation e.g. over encapsulation, extemporaneous preparation and controlled substances.

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Join Us at an Upcoming Conference!

Orlando, Florida

GPHA ANNUAL MEETING 2017
Orlando, Florida
February 13-15, 2017

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OUTSOURCING IN CLINICAL TRIALS WEST COAST
Burlingame, California
February 22-23, 2017

Pennsylvania

6TH CROWN CONGRESS 2017
Philadelphia, Pennsylvania
March 7-9, 2017

Baltimore

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

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