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