Newsletter | November 16, 2012

11.16.12 -- How Do I Get My Compound Into Phase I?

Pharmaceutical Online
How Do I Get My Compound Into Phase I?
By Dr. Scott E. Boley and Greg Ruppert
The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials.
Read more.
Outsourcing Articles

The Benefits Of Contract Manufacturing
By Oliver Mueller and Clifford Mintz, PhD, Suzhou Pharma Services
Contract manufacturing organizations (CMOs) offer a wide array of manufacturing services to the pharmaceutical and biotechnology industries. These services can range from production of small quantities of materials for R&D purposes, larger amounts for clinical study usage, and ultimately, full-scale production for commercial purposes. The global contract manufacturing market primarily includes solid and liquid dosage forms and injectables. Read more.

Comment On Biopharmaceutical Classification System And Formulation Development
By Mark Mitchnick, MD, and Robert W. Lee, PhD
The Biopharmaceutical Classification System (BCS) is an experimental model that measures permeability and solubility under prescribed conditions. The original purpose of the system was to aid in the regulation of post-approval changes and generics, providing approvals based solely on in vitro data when appropriate. Read more.

Maintain A Strong Drug Development Pipeline: Outsourcing Biomanufacturing
By Kate Hammeke, Nice Insight
A recent strategic partnering survey among large pharmaceutical companies revealed that outsourcing biomanufacturing is a common practice to maintain a strong drug development pipeline. Read more.

The Global PV Landscape-Considerations Beyond The U.S. And EU
By Norwich Pharmaceuticals
The World Health Organization describes pharmacovigilance as the process of detecting, assessing, understanding, and preventing adverse events associated with medicinal products, with the aim of enhancing patient care and safety. While the goal of pharmacovigilance remains constant, the methods, resources, and regulations that are designed to reach this goal are continuously being updated and optimized. Read more.

Expedite Development While Ensuring Successful Commercial Outcomes
As regulatory expectations continue to evolve in the area of pharmaceutical development, working with contract research and manufacturing organizations (CRMOs) that couple execution experience with high-end technical capabilities and contemporary quality systems will ensure the most value from strategic partnerships and enhance a project’s progress on its path toward commercialization. Read more.

MTOSoftgels: Providing Cohort-Specific, Hand-Filled Softgel Capsules For Dose Escalation Studies
By Velesco Pharmaceutical Services
When a client needed to manufacture softgel capsule clinical supplies in a low-cost, highly dose flexible manner, they turned to Velesco Pharmaceutical Services for MTOSoftgels. Read more.

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