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Manufacture Ingredients, Small Molecules, Dosage Forms, Formulation

Pediatric Formulation 101

This article was published in our sister publication, The Small Molecule Manufacturer, which celebrates the field of small molecule drug development and manufacturing with interviews and articles focusing on success stories, equipment, and new processing techniques. Read more about The Small Molecule Manufacturer here https://themedicinemaker.com/manufacture/small-but-never-forgotten

Ralph N. Landau, Head of Development at Cambrex, Whippany, NJ, USA.

The pediatric population is one group that has benefited from the industry's goal of becoming more patient-centric and, over the past 20 years, has seen gradual improvement in the number and quality of drugs available to them. In fact, over the course of the past two decades, there has been a five-fold increase in the number of pediatric drug approvals (according to Cambrex Market Intelligence, approvals increased from 10-20 per year to 50-70 annual approvals today).

Regulatory bodies are constantly working to update their guidelines regarding the implications of drug substances and excipients for pediatric patients. In the USA, Congress has passed several acts to accommodate pediatric drug development including:

1997 – the FDA Modernization Act (FDAMA) provided marketing incentives to manufacturers who conduct studies of drugs in children. It gave companies six months exclusivity in return for conducting pediatric studies.

2002 – the Best Pharmaceuticals for Children Act (BPCA) reauthorized a provision that was originally contained in FDAMA.

2003 – the Pediatric Research Equity Act (PREA) requires the pediatric assessments of new drug and biologic licensing applications for all new active ingredients, indications, dosage forms, dosing regimens, and routes of administration.

2007 – the FDA Amendments Act (FDAAA) requires that the FDA track and make publicly available certain pediatric information resulting from pediatric clinical trials.

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About the Author

Ralph N. Landau

Head of Development at Cambrex Whippany, NJ, USA.

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