The New Design Standard for Clinical Trials

Based on a 2013 study with Novartis for BioMedical Research, TKL Research developed a study that was approved and accepted by the FDA as a comprehensive design to test the photosensitization potential of the investigational product. We propose this methodology to be used as the new standard for photosensitivity clinical trials as this approach includes a positive control, confirming that it allows for the detection of photosensitization.

Please review our Methodology to Evaluate the Photosensitivity Potential of an Investigational Product in Healthy Volunteer Subjects PDF.

For inquiries please contact:
Gregory R. Anderson
Vice President, Business Development

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