June 2017

Altasciences Clinical Research
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Industry News

Guideline on Equivalence Studies for the Demonstration of Therapeutic Equivalence for Products that are Locally Applied, Locally Acting in the Gastrointestinal Tract

A few weeks ago, the EMA published a draft guidance the defines the in vitro and in vivo requirements to demonstrate equivalence for locally acting GI products. Altasciences has been at the forefront of the clinical research of locally acting GI products, as we have conducted more than 80 clinical studies on products such as Mesalamine (5-ASA). As discussed in the draft guidance, the studies required for locally acting GI products range from in vitro assessments to in vivo bioequivalence pharmacokinetic studies to therapeutic equivalence studies, but exactly which studies are required depend on the product. Products that show some degree of drug absorption and systemic bioavailability require a bioequivalence study in order to address systemic safety. This is the case with Mesalamine, which is absorbed systemically.

At Altasciences, we have worked on multiple formulations of Mesalamine, from rectal enema to suppository, oral delayed-release and oral sustained-release products. We can apply this experience to designing and performing bioequivalance studies on a number of other locally acting GI products.

 

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Kevork Mekhssian, Manager and Principal Scientist, Method Development, for Altasciences Clinical Research

BIOTHERAPEUTICS

Kevork Mekhssian, Manager and Principal Scientist, Method Development, for Altasciences Clinical Research, develops and implements innovative methodologies that simplify hybrid immunocapture - LC‑MS/MS workflows.

In recent years, LC-MS/MS based monoclonal antibody (mAb) quantitation assays have gained in popularity. Kevork and his team have developed a robust and reliable method for integrated kit-based sample preparation and mass spectrometric analysis to quantify Adalimumab (Humira), used for the treatment of rheumatoid arthritis.

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Dr. Marc Lefebvre, Vice-President, Scientific & Regulatory Affairs of Algorithme Pharma

THERAPEUTIC EQUIVALENCE

Dr. Marc Lefebvre is co-founder and Vice-President, Scientific & Regulatory Affairs, at Altasciences Clinical Research. He is responsible to elaborate and supervise scientific, regulatory and pharmacological decisions on each clinical trial that is conducted, and has played a key role in a significant number of Phase I/II PK or PD studies involving drugs acting systemically or locally in the gastrointestinal (GI) tract. Marc and his team have also perfected the study designs and clinical procedures to account for the large inter-subject variability in the bioavailability in Mesalamine.

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METABOLIC DISORDERS

With over 50 completed early stage trials for Metabolic Disorders and easy access to 225,000+ patients in our database, you can count on us to get your clinical trials started quickly and efficiently.

TOPICAL PRODUCTS

Our team’s expertise and clinical experience includes hundreds of completed topical product studies. With a full scope of support services, let us help you with your early phase topical product development.

SCIENTIFIC POSTERS

We look forward to presenting close to a dozen of our posters at the ASMS Conference in Indianapolis, from June 4th to 8th. Will you be there? If not, be sure to request your copy.

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Indianapolis, IN
June 4-8, 2017

 
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Montreal, QC Canada
June 17-22, 2017

 
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Chicago, IL
June 18-22, 2017
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San Diego, CA
June 19-22, 2017

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