Regularização de Produtos - Bioequivalência e Biodisponibilidade
Trabalhos Publicados
Use of PBPK_PD models to assess the clinical relevance of current BE criteria for generic drug products containing ibuprofen
Risk assessment for extending the BCS based biowaiver of IR dosage forms of fluconazole in adults to the pediatric population
Regulatory Considerations for Approval of Generic Inhalation Drug Products in US, EU, Brazil, China and India
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Bisoprolol Fumarate
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Efavirenz
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levofloxacin
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Metronidazole
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Stavudine
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Zidovudine (Azidothymidine)
2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance