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Nonclinical Testing Articles and Insights

Nonclinical Study Requirements for 505(b)(2) Development

On June 1, 2018, Camargo Pharmaceutical Services celebrated our 15th Anniversary. For this week’s blog, Camargo co-founders, Dr. Ruth Stevens, Chief Scientific Officer and Executive Vice President, and Ken Phelps, President, discuss an important question Camargo often hears from prospective clients: What Nonclinical Study Requirements

Pitfalls of Changing the Salt of a Listed Drug

Pitfalls of Changing the Salt of a Listed Drug The 505(b)(2) registration pathway for new drug products allows the applicant of the new drug product to reference the literature and the FDA’s findings of safety and/or effectiveness (e.g., as listed on the Listed Drug product’s

Therapeutic Equivalence Ratings Under 505(b)(2)

The FDA listing of therapeutic equivalence (TE) ratings can be a murky area for products approved under 505(b)(2) applications. The concept of TE ratings emerged from FDA regulations for generics and revolve around the announcement that the FDA would publish a current listing of all

Don’t conduct unneeded tox studies

In April I presented a webinar under the auspices of the DIA concerning preclinical bridging. During this webinar, we discussed the need to fill the toxicology gaps that may have been created during the time since the original reference listed drug was approved. These gaps,

Endpoint for GI Toxicity Clarified

NSAIDs are known to induce gastrointestinal (GI) tract toxicity, notably upper GI tract. Drugs that suppress gastric acid secretion such as histamine type 2 receptor antagonists, proton pump inhibitors (PPIs), NSAIDs (e.g., COX-2 selective drugs), and misoprostol (a prostaglandin E analog that also has mucosal