Pharsight® Reference Library — Reporting and Analysis Services (RAS)
Formulation Optimization and 505(b)(2)
Selected Articles and Publications
Antibiotics – Preclinical, Formulation Optimization
Marier JF, Brazier JL, Lavigne J, Ducharme MP. Liposomal tobramycin against pulmonary infections of Pseudomonas aeruginosa: a pharmacokinetic and efficacy study following single and multiple intratracheal administrations in rats. J Antimicrob Chemother. 2003 Aug;52(2):247-52.
Antibiotics – IR to ER Formulations (ANDA 76-220 9/2/03)
Marier JF, Ducharme MP, DiMarco M, Di Spirito M, Morelli G, Tippabhotla SK, Badri N, Rampal A, Monif T. Two open-label, randomized, crossover studies assessing the bioequivalence of ofloxacin administered as immediate-and extended-release formulations in healthy subjects. Clin Ther. 2006 Dec;28(12):2070-80.
BE Assessment Based on PD (Critical Path Initiative for Generic Drugs)
M DiMarco, JF Marier, I Morin, C Engel, S Gulnranson, NR Thudi, D Murpani, A Rampal, T Monif, TS Koundinya, K Deo. Pharmacodynamic Equivalence of Two Orlistat Capsule Formulation in Healthy Volunteers Under Fed Conditions. Int J Clin Pharmacol Ther., April 2008.
CNS (Neuropathic Pain) - Fixed-Dose Combination
C Seng Yue, J Lavigne, JF Marier, MP Ducharme, LE Pope, JE Berg, TA Brandt, M DiMarco. Population Pharmacokinetic Analysis of AVP-923 (30 mg Dextromethorphan and 30 mg Quinidine) Clinical Pharmacology & Therapeutic, 2006 03: PII-59.
Diabetes – Reformulation
JF Marier. A Comparative Bioavailability Study on Metformin Hydrochloride Oral Solution (100 mg/mL) with Metformin Hydrochloride 1000 mg Tablets, Following a 1000 mg Dose Under Fasting Conditions. Diabetes, 2004, 53: 6(S1); 1999-PO.
Pain - Reformulation
Chen H, Zhang Z, Almarsson O, Marier JF, Berkovitz D, Gardner CR. A novel, lipid-free nanodispersion formulation of propofol and its characterization. Pharm Res. 2005 Mar;22(3):356-61.
Pain – Transdermal (Reservoir to Matrix Technology)
Marier JF, Lor M, Morin J, Roux L, Di Marco M, Morelli G, Saedder EA. Comparative bioequivalence study between a novel matrix transdermal delivery system of fentanyl and a commercially available reservoir formulation. Br J Clin Pharmacol. 2007 Jan;63(1):121-4.
HIV -- Fixed-Dose Combination
Marier JF, DiMarco M, Guilbaud R, Dodard C, Morelli G, Tippabhotla SK, Singla AK, Thudi NR, Monif T. Pharmacokinetics of Lamivudine, Zidovudine and Nevirapine Administered as a Fixed-Dose Combination Formulation versus Coadministration of the Individual Products. J Clin Pharmacol 2007; 47(11):1381-9.
Hypertension - Fixed-Dose Combination
S Haworth, M Singh Bathala, J Lee, M Allison, S Rohatagi, JF Marier, I Rubets, D Salazar. A Fixed-Dose Combination of Olmesartan Medoxomil (OM) and Amlodipine Besylate (AM) Is Bioequivalent (BEQ) to Free Combination of the Agents. 22nd Annual Meeting of the American Society of Hypertension (ASH), P-433, 2007.