FDA Developing Tools for Evaluating Safety of Drugs

Peptides just one example of ongoing process

FDA has seen a rapid increase in the number of new drug applications submitted for peptide drug products.  The availability of generic versions of these products will be critical to increasing public access to these important medications. 

However, ensuring the quality and equivalence between generic and brand name peptide drug products raises a number of challenges, and those challenges differ according to the type of peptide drug.

As a class of drugs, peptides are increasingly important in medicine. FDA is developing the scientific tools to facilitate evaluations of these drug products and proposed generic equivalents.

FDA considers any polymer composed of 40 or fewer amino acids to be a peptide.

Peptides can occur naturally in the body or can be produced in a laboratory through chemical synthesis or recombinant DNA technology using other living systems (e.g., bacteria).

CDER researchers are evaluating a variety of sophisticated methods to determine how well each method can characterize peptides. Different types of techniques are becoming available that can be used independently or in conjunction with each other to gather comprehensive information on impurities, amino acid sequences, and distributions of peptide properties.


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