Succesfull collaboration with American biotechnology company
4Pharma are proud to announce that its collaboration with an American biotechnology company that develops drugs to improve therapies that improve neurological function in people with multiple sclerosis, spinal cord injury and other disorders of the central nervous system, have received Food and Drug Administration (FDA) approval to market for their levodopa inhalation powder – first and only FDA-approved inhaled levodopa for intermittent treatment of OFF episodes in people with Parkinson’s taking carbidopa/levodopa.
4Pharma’s responsibilities included taking a leading role in Data Management, Biostatistics along with SAS programming for the NDA submission program. 4Pharma’s experience working on NDA submissions was a great asset for providing the FDA with final deliverables in the evaluation of the safety of the Investigation product by summarizing four repeat dose studies in the Integrated Summary of Safety (ISS). This included but was not limited to providing all analysis datasets in both Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standard formats along with all accompanying and required documentation as defined by the Clinical Data Interchange Standards Consortium (CDISC).