June 2016

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Industry News

New FDA Guidance for Pharmacy Compounding

The Food and Drug Administration (FDA) has released a new guidance for pharmacy compounding titled Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act. According to the introduction of the guidance, it announces the FDA's "intention with regard to enforcement of section 503A of the Federal Food, Drug, and Cosmetic Act [...] to regulate entities that compound drugs."

 
See the Guidance

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Ask the Experts

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 Hardage, Director, Internal Monitoring Services

Clinical Operations

Chris Hardage, Director, Internal Monitoring Services, provides clinical operations supervision and direction to all employees and departments at our Kansas site to maintain our high level of quality. Click below to see the article from the Kansas City Business Journal on the new capabilities at this site or ask Chris a question about your own early phase clinical trial.

Dr. Martin Kankam, MD, PhD, MPH, Physician Investigator

Healthy Volunteers

Dr. Martin Kankam, MD, PhD, MPH, co-authored an article published in the British Journal of Clinical Pharmacology entitled An open-label study in healthy men to evaluate the risk of seminal fluid transmission of denosumab to pregnant partners. Click below to view the article or ask Dr. Kankam a question about your own healthy volunteer clinical trial.

More info
More info

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iCardiac Certified

Altasciences' clinical facility, Algorithme Pharma, in Montreal, Canada, has received its iCardiac Certification. Altasciences’ certified sites and iCardiac will work together to provide sponsors with recommendations concerning the design, conduct, analysis and interpretation of the cardiac safety profile of a drug during Phase I studies.

Consultant Connection

As a consultant, it is important to connect with a network of specialists who can offer expertise in key areas of drug development. Join the Clinical Consultants Connection LinkedIn group for access to like-minded consultants and gain visibility for biopharmaceutical companies looking for guidance!

Abuse Liability

Dr. Debra Kelsh and Dr. Brad Vince co-authored a poster recently presented at the Annual Meeting of the College on Problems of Drug Dependence (CPDD) in Palm Springs, CA entitled Evaluation of Human Abuse Liability of JZP-110.

Press Release
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View the Poster
 

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Pre-register for the Boston Symposium: Early Phase Development of Centrally-Acting Drugs

Join Us at an Upcoming Conference!

 
Chicago, Illinois

OCT Midwest
Chicago, Illinois
July 19-20

Boston, Massachusetts

OCT New England
Boston, Massachusetts
September 7-8

 
Bethesda, Maryland

ACCP
Bethesda, Maryland
September 25-27

Barcelona, Spain

CPhI Worldwide
Barcelona, Spain
October 4-6

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