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