| Industry Analysis |
| Profit For Good At Rottendorf Pharmaceuticals |
 | By Louis Garguilo, Executive Editor, Outsourced Pharma
The desire to work for a larger cause, to somehow apply whatever we do for a living to benefit society, continues to rise. And that desire can also elevate company revenues. |
| FROM THE EDITOR: Will The State Of New York Stifle Pharma Innovation? |
 | By Ed Miseta, Chief Editor, Outsourced Pharma
An anti-trust lawsuit is pending in the U.S. Court of Appeals for the Second Circuit that could have an impact on the ability of a pharmaceutical company to innovate and invest in medicines they think will best serve patient needs. |
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| » Drug Development |
| WHITE PAPER: Simplifying The Analysis Of Genomic Data In Clinical Trials |
By Comprehend Systems
Genomic sequencing has rapidly become a major part of translational research, with a dramatic increase in the number of clinical trials using this technology to understand and improve human health. Currently, according to ClinicalTrials.gov, there are 59 clinical trials using genomics data. |
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| » Discovery Research/Preclinical Development |
| ARTICLE: Bioanalytical Methods Transfer: Overcoming Data-Sharing Challenges |
By Roger Hayes, Ph.D., Vice President and General Manager of Laboratory Services, MPI Research
In a previous blog, I shared my perspective on best practices in bioanalytical methods transfer. Such practices aim to assure quality data across the drug development process. At the same time, they require a clear understanding of the challenges that come with sharing that data between a sponsor and a CRO. |
| ARTICLE: Expect The Unexpected: Daiichi Sankyo's Glenn Gormley Shares Post Interview Insights |
 | By Rob Wright, Chief Editor, Life Science Leader
I first met Glenn Gormley, M.D., Ph.D., at the 2014 PhRMA’s (Pharmaceutical Research and Manufacturers of America) annual meeting in Washington, D.C. At the time, I was engaged in a conversation with James (Mit) Spears, EVP and general counsel for PhRMA, and so my discussion with Dr. Gormley was brief. However, our encounter reminded me of an idea I once had for doing an article about Daiichi Sankyo. |
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| » Drug Substance/Drug Product Manufacturing |
| APPLICATION NOTE: Determining Design Space And Scale Up Conditions In Roller Compaction |
By Prasad.VN Challapalli, Manaud de Raspide, Satish Kamath, and Ram Kasina
Because of the numerous challenges involved in the roller compaction of low-dose active pharmaceutical ingredients, Patheon, Inc. recently conducted a study to determine the optimal design space and scale up conditions for such an application. Read on to learn what they found out. |
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| » Packaging/Assembly/Logistics |
| WHITE PAPER: Tips And Best Practices For Troubleshooting Biopharma Temperature Validation/Mapping |
By Paul Daniel and Jon Aldous, Vaisala
The FDA mandates the validation of environmental conditions that can affect the strength, identity, safety, quality, and purity of pharmaceuticals, medical devices, or biologics. To meet these requirements for temperature or humidity we perform a mapping validation, usually as part of an installation qualification and operational qualification of the environment, be it: incubator, fridge/freezer, stability chamber, cold room, or warehouse. |
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