Tips for Preventing Medication Errors in Clinical Trials

The integrity and safety of a clinical trial greatly depends on adherence to the carefully considered and approved administration protocol for a new investigational drug.  ...
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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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Common Pitfalls When Submitting Clinical Trial Study Data

Good quality clinical trial study data that comes through the FDA could potentially avoid delay in data extraction, review and verification that will help drive your product to ...
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What to Consider Before Conducting a First In Man Trial

Conducting a First In Man (FIM) clinical trial with a novel drug product is a complicated process that requires an abundance of caution. Also known as Phase 0 trials, FIM ...
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Do You Need an IND for Clinical Trials?

Generally speaking, if the intent of a clinical trial is to determine the safety and efficacy of a new drug, or changes to an existing drug, then IND submission is required. ...
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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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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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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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