Newsletter | January 30, 2013

01.30.13 -- Compliance Matters In Clinical Trials

Pharmaceutical Online Newsletter
Discovery Research
Dosage Form Production
Clinical Development
Dosage Form Development
Drug Substance Production
Featured Focus: Clinical Development
Compliance Matters In Clinical Trials
By Kai Langel, CRF Health
Subject compliance is a hot topic in the industry right now. Some of the discussions out there can be a little misleading, since 'compliance' means different things to different people and companies. Many eDiary vendors focus on a subject's compliance with data entry, whereas sponsors are more interested in the subject's compliance with the study procedures, and clinicians are interested in the subject's compliance with their medication and treatment.
ARTICLE: Accelerating Generic Approvals: 5 Keys To Being First To Market
WHITE PAPER: Transforming Clinical Trials
CASE STUDY: Partnering For Success In Personalized Medicine
NEWS: Topokine Therapeutics Secures Financing To Advance Clinical Development Of XAF5 Gel
NEWS: Baxter To Acquire Investigational Hemophilia Compound From Ispen Pharma
» Discovery Research
ARTICLE: Inflammation And The New Drug Development Paradigm
By Thomas Vihtelic, DVM, PhD
Opportunities abound for new treatments for inflammatory diseases, which afflict millions of people. Upward spiraling development costs, however, impede progress and delay relief for patients suffering from such debilitating diseases.
POSTER: A Drug Delivery Approach To Achieve Zero-Order Release Kinetics
NEWS: New Research Partnership To Further Drug Discovery For Chronic Diseases
NEWS: GVK Bio, Endo Pharmaceuticals Partner To Discover Novel Small Molecules
» Drug Substance Production
CASE STUDY: Focus On Content Uniformity Via Flow Control Systems
» Dosage Form Development
WHITE PAPER: Targeting PK And Patient Needs With Versatile, Timed-Based, Oral Drug Delivery
By Michael A. Gosselin, Ph.D., and Vincent Parrino, M.Sc., M.B.A., Aptalis Pharmaceutical Technologies
In 2009, more than one half of the drug candidates going beyond Phase II development were line extensions or modifications of existing products, rather than representing truly innovative new molecules, according to a 2010 annual report from the consultancy firm CMR International, a Thomson Reuters business. Clearly, pharmaceutical developers pursue product opportunities that meet patients' needs, not only by discovering new molecular entities, but largely by repositioning existing products across multiple indications, developing alternative dosage forms, or reformulating them to modify pharmacokinetic profiles.
» Logistics
DATASHEET: Outsourced Services
By Life Science Logistics
VIDEO: Saving Lives With Same-Day Delivery Of Healthcare, Pharmaceutical And Biotech Products
» Dosage Form Production
SERVICE BROCHURE: Outsourcing In The Pharma Industry: Experience, Expertise, And Enthusiasm
» Packaging/Assembly
SERVICE BROCHURE: Key Steps To Consider When Working With A CDMO To Identify Optimal Packaging Options