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Updated: Aug 20, 2025

Solid Phase Synthesis of a Functionalized Bis-Peptide Using "Safety Catch" Methodology

Solid Phase Synthesis of a Functionalized Bis-Peptide Using "Safety Catch" Methodology

Published on: May 15, 2012

Practical Protocols for Solid-Phase Peptide Synthesis 4.0.

Beatriz G de la Torre¹, Fernando Albericio^2,3

¹KRISP, College of Health Sciences, University of KwaZulu-Natal, Durban 4001, South Africa.

Methods and Protocols

|November 22, 2022

Summary

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The Food and Drug Administration (FDA) categorizes drugs into New Chemical Entities (NCEs) and Biologics. This classification is crucial for understanding drug development and regulatory pathways.

Area of Science:

Pharmaceutical Sciences
Regulatory Affairs

Background:

The Food and Drug Administration (FDA) regulates pharmaceutical products.
Understanding drug classifications is essential for regulatory processes.

Discussion:

NCEs are typically small molecules developed through chemical synthesis.
Biologics are large molecules, often derived from living organisms, including vaccines and gene therapies.

Key Insights:

The distinct nature of NCEs and Biologics necessitates different regulatory review pathways.
This categorization impacts manufacturing standards, quality control, and post-market surveillance.

Outlook:

Future drug development may see increased complexity in these categories.

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Continued regulatory clarity is essential for innovation in both NCE and Biologic drug classes.