Blog
5 Questions When Planning a Nonclinical Toxicology Program for Biotherapeutics
Encountering challenges while developing a new drug is expected, but drug developers who understand the pitfalls are often better prepared to navigate them and emerge successfully. Nonclinical safety assessment is a highly complex and molecule-specific process, but...
You’ve Got Molecules, We’ve Got Solutions
We offer a true, single-platform, end-to-end solution that can be catered to your specific drug discovery and development needs – saving you money while providing industry-leading turnaround times. With solutions for both small- and large-molecule development, our...
Partner Up – A Nonclinical Talk with Toxicology Consultant, Grace Furman
Engaging the right partners at the right time is essential to drug developers and the success of their compound. We sat down with Grace Furman, small-molecule toxicology consultant at Paracelsus, Inc., to get her perspective on some of the most pressing challenges and...
Addressing Safety Testing of Drug Metabolites (MIST) in Drug Development
Metabolites in safety testing (MIST) has become an integrated part of drug metabolism research in drug development, and is a widely discussed topic within the drug development industry. Recent guidance from the U.S. Food and Drug Administration (FDA) on safety...
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 necessary step...
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...