TGP Paracetamol safe, effective similar to leading brands in market, says clinical study

January 27, 2014 11:17 pm 

By Sweety dela Torre

MANILA, Jan. 27 (PNA) — The Generics Pharmacy (TGP)Paracetamol was found to be safe and effective similar to the leading brands in the market.

This was found on the recent human clinical study conducted by the Center of Biopharmaceutical Research of the De la Salle Health Science Institute (DLSHSI).

"We can say that the TGP Paracetamol is bioequivalent or has the same clinical effects of the leading innovator paracetamol brands," said Dr. Rita Grace Alvero, director for Research Support and Extension Services , and chairman of Unit and Drug Testing Laboratory at DLSHI, who conducted the three-month study among males.

A human clinical study is a particular kind of research that is usually done by pharmaceutical companies to assess the safety and efficacy of a new drug.

"We are not measuring the clinical efforts; we are more focused on the quantitative analysis of the TGP Paracetamol. This includes the monitoring the safety and tolerability of the three drugs," Alvero said during the study presentation.

The team's study made use of randomnized three-way crossover single dosed bioequivalence study. A bioequivalence study is the objective way of measuring absorption in the body while a three-way cross-over entails that one subject had to take of the three drugs indifferent dates of intervals.

"The team tested the rate and extent of absorption of the TGP paracetamol after single dose administration against the leading innovator brands," Alvero said during a press conference Monday held at the Shangri-La Hotel in Makati City.

After a three-month period, results of the study revealed that the parameters involved in the evaluation of the TGP paracetamol were more or less similar of the leading paracetamol and innovator paracetamol drugs, she said. (PNA)



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