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IND Application

Ensure a Successful Clinical Translation with DMPK Strategies

Ensure a Successful Clinical Translation with DMPK Strategies

DMPK - A Key Step, Every Step of the Way Drug metabolism and pharmacokinetics (DMPK) is a crucial component in the success of your drug development – at every stage, from discovery to preclinical to clinical. DMPK studies set basic expectations of drug behavior, which...

New U.S. FDA DDI Draft Guidance for Therapeutic Proteins

New U.S. FDA DDI Draft Guidance for Therapeutic Proteins

Preclinical drug-drug interactions (DDI) studies provide preliminary analysis and predict risk potentials for the investigated compounds when co-administrated with other drugs during future in-human trials. Knowledge pertaining to DDI studies is still rapidly...

ACT Annual Meeting: Managing Roadblocks to Success

ACT Annual Meeting: Managing Roadblocks to Success

One of the largest shares of preclinical testing in any drug development program is toxicology studies, yet bringing together the community supporting this pivotal development stage does not happen often enough. Fortunately, the 2020 American College of Toxicology...

Ramp Up: What Drug Developers Need to Know

Ramp Up: What Drug Developers Need to Know

Many drug development companies are prepared to move their programs forward and effectively submit preclinical packages to regulatory bodies. In the challenging business of drug development, disruptions and obstacles are elements that must be part of the conversation...

Partnerships that Prioritize the Customers

Partnerships that Prioritize the Customers

Around the globe, drug developers are trying to understand how the pandemic will impact the progress of their molecule during preclinical testing. Depending on a testing partner's response to the pandemic, your project's status can look drastically different from one...

What You Need To Know Planning for an IND Submission

What You Need To Know Planning for an IND Submission

For drug developers ready to progress a molecule to the pivotal clinical trial stage, filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) is a significant milestone. Drug developers approach this task with a wide range...