Under ANMAT regulations

Determination of active ingredients and metabolites in biological samples

For pharmacokinetic, bioavailability, bioequivalence and Phase I studies.

Development of Bioanalytical Methodologies under ANMAT Disposition 5040/06 - 1746/07 and the FDA/CDER Guidance for Industry, Bioanalytical Method Validation, 2001.
Analysis of biological samples for bioavailability-bioequivalence studies.
Analysis of biological samples for clinical studies (Phase I).

Molecule listing

Validated Bioanalytical Methods

Molecule	Detection Equipment
Mycophenolic Acid	HPLC-UV
Amoxicillin	HPLC-UV
Betamethasone	HPLC-UV
Carbamazepine and Epoxide	HPLC-UV
Ciprofloxacin	HPLC-UV
Desloratadine	HPLC-FLD
Didanosine	HPLC-UV
Phenytoin	HPLC-UV
Digoxin	Chemiluminescence
Efavirenz	HPLC-UV
Emtricitabine	HPLC-UV
Enalapril-Enalaprilat	HPLC-UV
Enalapril	Mass Spectrometry (HPLC/MS/MS)
Furosemide	HPLC-UV
Irbesartan	HPLC-UV
Isotretinoin	HPLC-UV
Lamotrigine	HPLC-UV
Lamivudine / Zidovudine	HPLC-UV
Lamivudine	HPLC-UV
Levothyroxine	RIA
Levodopa	HPLC-UV
Metformin	HPLC-UV
Nelfinavir	HPLC-UV
Nevirapine	HPLC-UV
Oxcarbazepine	HPLC-UV
Rhein	HPLC-UV
Saquinavir	HPLC-UV
Simvastatin	Mass Spectrometry (HPLC/MS/MS)
Sirolimus	Mass Spectrometry (HPLC/MS/MS)
Tacrolimus	Mass Spectrometry (HPLC/MS/MS)
Tenofovir	HPLC-FLD / HPLC-UV
Topiramate	HPLC/MS/MS
Trimebutine - Nortrimebutine	HPLC-UV
Warfarin	HPLC-UV
Zidovudine - Abacavir	HPLC-UV
Zidovudine	HPLC-UV

Conducting Clinical Research studies from Phase I to IV with the highest quality standards.

Design, execution and analysis of bioavailability, bioequivalence and pharmacokinetic studies.

Good Pharmacovigilance Practices program under ANMAT regulations.