Benefits of Utilizing the 505(b)(2) Pathway for Prodrugs
Over the past decade, at least 30 prodrugs have been approved by the US Food and Drug Administration (FDA). It is likely that prodrugs will continue to be important in…
Read MoreStrategic Advice
Pre-IND Meeting Guide: Benefits & How to Prepare
Regulatory guidelines allow for formal meetings between the FDA and sponsors or applicants to discuss the development and review of an investigational new drug (IND) application for drugs or biologic…
Read More
When Should You Hire a Clinical Pharmacologist?
Because of the importance of clinical pharmacology to drug development, it is essential to consider the expertise of your product development team early and to determine whether additional clinical pharmacology…
Read More
What is a 505(b)(2)?
The 505(b)(2) New Drug Application (NDA) is a streamlined NDA process in which the applicant relies upon one or more investigations conducted by someone other than the applicant and for…
Read More
Cost-Effective Techniques for Creating QSP Models
Quantitative systems pharmacology (QSP) modeling can be an effective tool to solve a variety of drug development questions including understanding a drug’s mechanism of action, determining a drug’s biomarkers, and…
Read More
Fostering Inclusion and Diversity in Clinical Trials
Inaccessibility, inadequate engagement, and lack of trust—these are just some of the issues that limit inclusion and lead to a lack of diversity in clinical trials. So, why is diversity…
Read More
Cellular & Gene Therapy: Implications on Drug Development
What is Cellular & Gene Therapy? Genes are defined by the NIH as the “basic physical and functional unit of heredity.” We receive these valuable sequences of DNA from our…
Read More