December 2016

Altasciences
 
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Industry News

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Healthy normal volunteers

 

Industry News

CLINICAL PHARMACOLOGY SECTION OF LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS — CONTENT AND FORMAT

On December 2nd, the FDA published a guidance intended to assist applicants in preparing the clinical pharmacology section of prescription drug labeling to meet regulatory requirements and ensure appropriate consistency in the format and content. Optimal pharmacotherapy is driven by an understanding of a drug’s clinical pharmacology and the clinical context in which the drug will be used. Important clinical pharmacology attributes to consider in therapeutic decision making include, but are not limited to, drug mechanism of action, pharmacodynamics (e.g., both on-target and off-target pathways), and pharmacokinetics in a variety of settings and specific populations. The new FDA guidance will help sponsors present the required information in a consistent and concise manner to help physicians in their clinical decision making across a range of patient sub-groups.

 
VIEW 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.

Dr. Anahita Keyhani, Director, Method Development Group

METHOD DEVELOPMENT

Dr. Anahita Keyhani leads our team of over 25 scientists dedicated to method development. Our method development expertise includes sensitive and reliable bioanalytical methods for generics and New Molecular Entities in various biological matrices.

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

Scott Smiley, Director, Pharmacy Operations

OPIOIDS FOR CHRONIC PAIN

Scott Smiley, Director, Pharmacy Operations, presented Review of CDC Guidelines for Prescribing Opioids for Chronic Pain in November, as part of the 3rd Human Abuse Liability & Abuse-Deterrent Formulations conference.

Click below to request the presentation or to ask a question of Scott.

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HNVs

Healthy normal volunteers (HNVs) play a critical role in drug development. They are the key to gaining safety and efficacy data in early phase trials. Think all clinical research facilities have the knowledge and expertise to conduct a trial in healthy volunteers? Think again!

LIGHTS FOR CHARITY

Every year at our Kansas site, we create our own holiday light extravaganza. Our display of over 175,000 LED lights is synchronized to music and is a major holiday attraction in the Kansas City area. Started by Dr. Brad Vince, this Holiday Lights Display takes three men about three weeks to install and synchronize.

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Thank you for a wonderful 2016. Happy Holidays, from our team to yours!

Join Us at an Upcoming Conference!

 
Miami, Florida

8TH ANNUAL SCOPE SUMMIT 2017
Miami, Florida
January 24-25, 2017

Orlando, Florida

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

 
Burlingame, California

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

Pennsylvania

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

See all conferences

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