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Nonclinical Testing Articles and Insights

Evaluating Impurities in New Drugs to Prevent Delays in Development

During the development of new small molecule drug products, developers must conduct impurity and degradant evaluation at several points in the program and to varying degrees. These evaluations include the active pharmaceutical ingredient (API), also known as the drug substance, and the drug product (formulated

Understanding the Elements of a Typical IND-Enabling Package

As a cornerstone of the drug development process, nonclinical investigational new drug (IND)-enabling studies are essential for supporting first-in-human (FIH) dosing for novel therapeutics. High-quality IND-enabling studies demonstrate that a drug is reasonably safe for use in humans and that it exhibits sufficient pharmacological activity

Next Step in the NHP Shortage: New FDA Guidelines

Previously on this blog, we have explored the 2020 Chinese export ban on non-human primates (NHPs) and its consequences on pharmaceutical research. In that same post, we explored potential solutions to keep sponsor programs on track. In response to the NHP shortage and the resulting

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Sponsors developing biologics must manage numerous scientific considerations specific to large-molecule products, including biochemical characterization studies to confirm structural identity, biological activity studies to confirm potency, and mechanism of action maintenance. Clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy.

Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

The development of biologics represents a major advancement, enabling the treatment of patients with many illnesses for which no other therapeutics were previously available. When developing biologics, sponsors must manage several scientific considerations specific to large-molecule products, including biochemical characterization studies to confirm structural identity,

Advancing from Research to Development: What Can Go Wrong?

The drug development process is a long journey, beginning with drug discovery, moving through nonclinical and clinical studies, and ultimately culminating in regulatory approval. With many steps in between, each as important as the next, multiple factors regarding development strategy and approach must be considered

Anatomy of a Nonclinical Study Monitoring Report

Not surprisingly, the majority of nonclinical contract research organizations are not in glamorous locations. So arriving at the front door of one at 7:30 on a snowy or rainy morning isn’t likely on anyone’s bucket list. However, the experienced nonclinical scientist understands that no matter

Nonclinical Development Strategy and Study Design

With drug discovery completed and your lead asset identified, it’s time to initiate IND-enabling activities, moving one step closer to clinical deployment. According to the Tufts Center for the Study of Drug Development, fewer than 10 percent of nonclinical lead assets move into the clinic.

Advantages of the 505(b)(2) Pathway in Nonclinical Development

The 505(b)(2) new drug application (NDA) pathway can provide unique advantages from the nonclinical development perspective that can save significant time, money, and resources. Compared to the 505(b)(1) NDA pathway, which is more standardized and follows the general guidance provided by the International Conference on

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 label) to fulfill various registration requirements. From a nonclinical

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

Reference Listed Drugs (RLDs): Can More Than One Be Used?

Can a 505(b)(2) NDA have more than one RLD? In a word, the answer is “yes.” When using the 505(b)(2) regulatory pathway, sponsors may rely on the agency’s previous findings of safety and/or efficacy of an already approved product which is termed the reference listed