Despite recent events, the demand for new therapies across all indications continues to rise.

We've developed the materials below to offer alternatives to address some of your drug development challenges during these unusual times.

As always, we're here to help.

5th edition of the Transporter Reference Guide now available!

This guide updates the considerations and best practices from our highly regarded 4th edition including:

• Things to know in 2020 based on new FDA guidance

• Metabolism and drug transporters in safety testing

• Evaluation of DDI potential of metabolites

• Concentration Selection Cheat Sheet

• Regulatory requirements

• Decision trees

• Waiving of clinical endpoints
  
  

Staying the course: progressing drug development during the COVID-19 pandemic through bioequivalence studies

With the ongoing COVID-19 pandemic extensively impacting clinical trials, learn how bioequivalence studies (BCS) can be a suitable stopgap measure in the interim.

The objective of the BCS is to predict in vivo performance of drug products from in vitro measurements of dissolution, solubility and permeability in order to simplify and speed up drug development. To facilitate the research community, an innovative in vitro dissolution absorption system (IDAS) has been developed to study generic compounds and new chemical entities.

The 1st edition of the Preclinical Toxicology Guide now available!

This guide provides an overview of preclinical and non-clinical safety and toxicology studies necessary to be conducted for a successful IND submission and advance a drug candidate through the development phase and covers the following concepts among others:

• Regulatory considerations

• Components of general toxicity evaluation in GLP studies

• Ocular and dermal toxicity evaluation
  
  

IDAS: The Future of Dissolution and Permeation Evaluation

In this paper, we discuss a unique, new, proprietary technology platform called the In Vitro Dissolution Absorption System, or IDAS. While these are early days in terms of exploring the capabilities of IDAS, we present the results of several applications of the platform and discuss its unique power to discriminate between formulations and reveal the sometimes surprising interplay between the processes of dissolution and permeation.