A Rundown on NEW Updates of FDA's Clinical Trial Data Submission Guidelines

In October 2017, an updated version of the FDA’s Technical Conformance Guide (TCG) was released.  The TCG has been around for about 4 years and provides recommendations on how ...
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Successful Clinical Trials in Immunooncology Are Just Getting Started

Pictured: The antibody binding domain of nivolumab, bound to PD-1. Image source: Dr. David S. Goodsell of the Scripps Research Institute. Public domain, accessed via Wikimedia ...
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5 Key Trends Shaping the Future of Drug Development

The FDA’s Center for Drug Evaluation and Research (CDER) offers an all-encompassing bundle of information that is of interest to the pharmaceutical industry to help get their ...
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Immunotherapy Will Have A Diverse Impact In Respiratory Disease Trials

Pictured: A schematic of how immunotherapy could be used against respiratory allergies. Published by Sari Sabban in “Development of an in vitro model system for studying the ...
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Immunotherapy’s Clinical Trial Impact In Endocrinology Is Still In Flux

Immunotherapy’s whirlwind of clinical trial successes and failures show no signs of abating.[1] Each passing week finds more immunotherapy trials entered into the ledger, and ...
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What Are the Consequences of Fabricating Clinical Trial Data?

From time to time we hear about situations where investigators are involved with the fabrication of clinical trial data.  Not only is this unethical because culprits are ...
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5 Tips for Evaluating the Best CRO for Your Needs

The trend of outsourcing in both small biotech and large pharmaceutical companies is moving upward.  In fact, Contract Pharma’s 2016 Annual Outsourcing Survey showed that 80% ...
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A Simple Guide to Designing an Effective Dose Response Study

For safe and effective use of new drugs, clinicians need to determine the appropriate starting dose and the best way to adjust dosage to the needs of a particular patient.  But ...
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Are You Ready for a Phase I, First in Human Safety Trial?

So, you have a novel drug ready for Phase I First in Human safety trial.  What dose should you start with that will be reasonable and acceptable to the FDA?  The answer ...
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