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Whitepaper: Accelerating drug development using 505(b)(2) regulatory pathways

Navigating the 505(b)(2) Pathway: Lab Ofichem’s Expertise in Repurposed Drug Development

In an ever-evolving pharmaceutical landscape, the 505(b)(2) regulatory pathway has emerged as a strategic avenue for small molecule drug development. Here we describe the critical role of Contract Development and Manufacturing Organizations (CDMOs) in facilitating successful API development for repurposed drugs. Discover how Lab Ofichem, a leading CDMO, leverages its expertise and capabilities to support pharmaceutical companies in navigating the complexities of this regulatory pathway.

Accelerating drug development using 505(b)(2) regulatory pathways

As with traditional drug development, a 505(b)(2) submission contains full reports of safety and effectiveness investigations. In this case, not all of the required information has to come from studies conducted by the applicant, and previously completed investigations can be cited. The 505(b)(2) pathway allows for innovation by permitting modifications, such as new dosage forms or different indications, without requiring a full set of preclinical and clinical trials.

Lab Ofichem facilitate successful API development for repurposed drug

Market Access: The Benefits of the 505(b)(2) Pathway

By using existing data from previously approved research, drug development companies can avoid the necessity of extensive preclinical and clinical studies for every aspect of the new drug, leading to significant reductions in the overall development timeline and costs. This facilitates a quicker route to the market, which is particularly important for drugs with meaningful improvements or modifications. Ultimately, patients will potentially have better access to innovative treatments.

Lab Ofichem: Excellence in Small Molecule API Development

Lab Ofichem is a European CDMO specialized in the development and subsequent GMP manufacture of small molecule APIs. The family-owned company is nearly 50 years old and has a long history of regulatory compliance in multiple markets, and a strong reputation for reliability and quality. Developing repurposed drugs with the regulatory requirements of the 505(b)(2) pathway is a core competence of the team.

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