Camargo

DECEMBER 22, 2021

For example, streamlined programs can be limited to literature searches, nonclinical studies, demonstration of bioequivalence to an approved product, or a combination of nonclinical and bioequivalence studies, and their relatively low costs may be appealing. This is a key factor in designing Phase 2 and 3 trials.

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

Camargo

FEBRUARY 10, 2021

Pharmacokinetics (PK) and bioequivalence (BE) studies serve as the foundation of determining the fate of drug products. This blog post will discuss how PK modeling can contribute to sample size estimation, a key aspect of a clinical trial protocol.

Production 133

Production Bioavailability In-Vivo Bioequivalency 133

Camargo

JULY 8, 2021

Researchers at the University of Southern California in conjunction with the National Cancer Institute are currently conducting a Phase II clinical trial of the MAOI phenelzine in prostate cancer patients and have announced in an interim study publication that it has thus far demonstrated efficacy. .

Development 130

Development Bioequivalency Gene Expression Drugs 130

FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.

Trials 59

Trials Clinical Trials Clinical Trials Drugs 59

Pharmaceutical Technology

FEBRUARY 23, 2023

How does bioavailability play a role in biopharmaceutics? Now fraction absorbed and bioavailability are often confused and used interchangeably. The Translational Pharmaceutics approach of testing multiple formulations within a clinical trial can also be applied to FIH studies.

Development 246

Development Drugs Bioavailability In-Vivo 246