This blog asks and answers 10 critical drug development questions whether you have a new molecular entity or are repurposing a drug already in clinical use.
Clinical pharmacology provides a valuable opportunity to accelerate the near-term development of existing repurposed drugs for COVID-19 treatment and therapy.
A quantitative modeling approach can be used to predict the optimal time to administer influenza vaccine during pregnancy to provide protection to infants at birth.
This blog discusses the development of pharmacokinetic CDISC data standards and the impact of building them for electronic regulatory submissions.
This blog described some important strategic considerations for successful development of complex biologics.
Immuno-oncology – The Breakthrough in Cancer Therapeutics Cancer immuno-oncology (IO) uses the body’s natural defenses to combat cancer. These therapies stimulate an individual’s immune system and restore its ability to identify and destroy cancer cells. Anti-cancer immune responses are often inhibited during the spread of cancer. Ultimately, IO therapy expedites long term responses against cancer … Continued
Read this blog profiling the student scholarship winners for the 28th annual meeting for the Population Approach Group in Europe (PAGE).
This blog reviews trends for using health economics and outcomes research and real-world evidence to evaluate the value of medicines and health technologies.
The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance date for submitting many types of files—Drug Master File (DMFs) and commercial investigational new drugs (INDs)—in the electronic Common Technical Document (eCTD) format. A DMF provides confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, … Continued