Therapeutic Equivalency

Publication Title: 
Journal of Clinical Pharmacology

This study was undertaken to assess the bioequivalence between a new formulation of propofol 2% and the commercially available product Diprivan. Secondary objectives were to compare the times to onset of and emergence from hypnosis, the hemodynamic effects, and the safety profiles. Twelve healthy male volunteers were included in a randomized crossover study. Subjects were administered a 2-mg/kg single bolus injection of each formulation separated by a 7- to 10-day washout period. Plasma propofol was determined by reversed-phase liquid chromatography with fluorescence detection.

Author(s): 
Abad-Santos, Francisco
Gálvez-Múgica, M. Angeles
Santos, M. Angeles
Novalbos, Jesús
Gallego-Sandín, Sonia
Méndez, Paloma
Casimiro, Cesar
Gilsanz, Fernando
Publication Title: 
The American Journal of Tropical Medicine and Hygiene

Sera collected at various time intervals from healthy Thai male subjects after the administration of the three oral formulations of dihydroartemisinin (Cotecxin) manufactured in the People's Republic of China, a formulation manufactured by Arenco n.v. Pharmaceutica in Belgium, and a formulation manufactured by the Faculty of Pharmacy of Mahidol University in Thailand) were investigated for their ex vivo blood schizontocidal activities against the K1 strain of Plasmodium falciparum.

Author(s): 
Kongthaisong, Monticha
Na-Bangchang, Kesara
Mungthin, Mathirut
Sinchaipanid, Nuttanan
Tan-Ariya, Peerapan
Publication Title: 
Antimicrobial Agents and Chemotherapy

Tetra-acetamide pyrroloquinazolinediamine (PQD-A4) and bis-ethylcarbamyl pyrroloquinazolinediamine (PQD-BE) are new derivatives of pyrroloquinazolinediamine (PQD) and are being investigated as potential chemotherapeutic agents for the treatment of malaria. Comparative studies to assess the therapeutic indices of PQD-A4, PQD-BE, and PQD were conducted in Plasmodium berghei-infected rats following daily intragastric dosing for three consecutive days. Artesunate (AS), a standard drug for treatment of severe malaria, was used as a comparator.

Author(s): 
Xie, Lisa H.
Li, Qigui
Lin, Ai J.
Smith, Kirsten
Zhang, Jing
Skillman, Donald S.
Publication Title: 
Journal of Vector Borne Diseases

BACKGROUND & OBJECTIVES: The availability of numerous brands of artesunate in our drug market today places clinicians and pharmacists in a difficult situation of choice of a suitable brand or the possibility of alternative use. The aim of the present study was to predict the bioequivalence of nine brands of artesunate tablets marketed in Nigeria using in vitro tests. METHODS: The in vitro dissolution study was carried out on the nine brands of artesunate tablets using the basket method according to US Pharmacopoeia (USP) guidelines.

Author(s): 
Esimone, C. O.
Okoye, F. B. C.
Onah, B. U.
Nworu, C. S.
Omeje, E. O.
Publication Title: 
Antimicrobial Agents and Chemotherapy

The two fixed-dose combinations of dihydroartemisinin and piperaquine (Artekin and Arterakine) were found to be bioinequivalent in healthy Vietnamese subjects. However, because the peak plasma concentrations and areas under the concentration-time curves of dihydroartemisinin and piperaquine were only marginally different between the two formulations, similar therapeutic efficacies are expected in the treatment of malaria infections.

Author(s): 
Chinh, Nguyen Trong
Quang, Nguyen Ngoc
Thanh, Nguyen Xuan
Dai, Bui
Geue, Jason P.
Addison, Russell S.
Travers, Thomas
Edstein, Michael D.
Publication Title: 
Malaria Journal

BACKGROUND: Existence of anti-malarial generic drugs with low bioavailability marketed on sub-Saharan Africa raises a concern on patients achieving therapeutic concentrations after intake of such products. This work compared bioavailability of one generic tablet formulation with innovator's product. Both were fixed dose combination tablet formulations containing artemether and lumefantrine.

Author(s): 
Minzi, Omary M. S.
Marealle, Ignace A.
Shekalaghe, Seif
Juma, Omar
Ngaimisi, Eliford
Chemba, Mwajuma
Rutaihwa, Mastidia
Abdulla, Salim
Sasi, Philip
Publication Title: 
Antimicrobial Agents and Chemotherapy

Artesun-Plus is a fixed-dose combination antimalarial agent containing artesunate and amodiaquine. The current study was conducted to compare the pharmacokinetic and safety profiles of Artesun-Plus and the WHO-designated comparator product Artesunate Amodiaquine Winthrop. To overcome the high intrasubject variability of artesunate, the study applied a two-sequence and four-period crossover (2 by 4), replicate study design to assess bioequivalence between the two products in 31 healthy male Chinese volunteers under fasting conditions.

Author(s): 
Liu, Yun
Hu, Chaoying
Liu, Gangyi
Jia, Jingying
Yu, Chen
Zhu, Jianmin
Zheng, Qingsi
Zhang, Kanyin E.
Publication Title: 
Arquivos Brasileiros De Endocrinologia E Metabologia

OBJECTIVE: To evaluate the bioavailability of vitamin D in capsules as compared with oily drops in nuns living in a closed community with very low sun exposure. METHODS: A randomized, 2 x 2 crossover, open clinical trial was conducted, with 18 nuns aged between 20 and 75 years. Samples were collected in the fasting state and at 4, 8, 12 and 24 hours following the administration of capsules and oily drops (both containing vitamin D3 66,000 UI plus vitamin A 13,200 UI) to determine serum 25 hydroxyvitamin D concentrations (25OHD), at baseline and 90 days after.

Author(s): 
Coelho, Iara Maria Gomes
Andrade, Luena Dias de
Saldanha, Lunnara
Diniz, Erik Trovão
Griz, Luiz
Bandeira, Francisco
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