Blog
Internal Standard Variation Case Studies: A Look into the Latest Whitepaper
The use of Internal Standards (IS) is essential to Liquid Chromatography-tandem Mass Spectrometric (LC-MS/MS) quantitative bioanalytical methods. Yet, there are no set methodologies or widely adopted criteria among laboratories for establishing and assessing Internal...
Guidance Updated by U.S. FDA for Safety Testing of Drug Metabolites
Recent guidance from the U.S. Food and Drug Administration (FDA) on Safety Testing of Drug Metabolites helps drug developers know when and how to identify and characterize drug metabolites. Identifying and characterizing a drug’s metabolic profile is a...
Regulatory Pathways: IND Requirement Variations Between U.S. FDA, OECD and NMPA
The development path for bringing new drugs and therapeutics to market requires extensive planning to meet the short- and long-term needs of products intended for global registration. Because international regulatory agencies may have different requirements for...
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...
Virtual Tours Available Today
Explore our New Jersey facilities from wherever you are working, even the comfort of your own home. Virtually tour our New Jersey facilities in Cranbury and Plainsboro to learn about our Bioanalytical and DMPK capabilities and instrumentation to support your drug...
Transitioning to Phase I Clinical Trials
Developing biologic solutions is a complex process, and bridging bioanalytical assays from preclinical to phase I clinical trials is a demanding step in advancing your therapeutic. While maneuvering through regulatory requirements and intensive testing, it is easy for...
Dual Filing your IND Package: Planning Pays Off
Navigating the Investigational New Drug (IND) submission process for your drug development program can be a complex process, especially when filing with various regulatory agencies and pursuing multiple markets. However, dual, or globally filing an IND package can...
New U.S. FDA DDI Draft Guidance for Therapeutic Proteins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
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
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...
In the News: The IND Application, Timelines & Advice for Small Drug Developers
Recently our WuXi AppTec subject matter experts contributed to notable publications. Below is a quick recap of where to find them sharing their knowledge, advice and passion for drug development. Pharma Manufacturing Keys to Submitting a Successful IND Application to...
Alliances for Innovation: Insight from Steve Yang
In the face of a wide-spread pandemic, something extraordinary is happening in the drug development industry – competitors are becoming collaborators and collaborations are accelerating results. WuXi AppTec’s Co-CEO, Head of RSD, Head of WuXi Testing, Steve Yang,...