As the FDA continues to issue drug product specific bioequivalence
guidances, the role of analytical tests for these dosage forms play a critical role in these applications," said Dr.
Iqbal Choudhary said that over 200 scientists and researchers from various institutions of the country will be attending the national meeting, organised by the Center for Bioequivalence
Studies and Clinical Research (CBSCR) of Dr.
This clinical study, also called a bioequivalence
study, is the only one needed to confirm the effectiveness and the safety of the product, with a view to complete the filing of the marketing authorization (MA) application for ZENEO Methotrexate in Europe.
The Vice Chancellor viewed that bioequivalence
study of the local drugs would build confidence of the consumer on its efficacy and resultantly enhance exports.
But the FDA "has determined that this approach is no longer appropriate" to establish bioequivalence
and "is revising its guidance to industry for how to conduct premarket bioequivalence
studies in generic bupropion products.
Astellas announced it plans to file a complaint for declaratory and injunctive relief in US District Court in Washington, DC challenging the FDA's decision to apply standard bioequivalence
testing for the approval of generic immunosuppressive drugs, like tacrolimus.
Baltimore, MD-based Next Breath focuses on conducting in vitro bioequivalence
testing for nasal sprays and chemistry, manufacturing and controls (CMC) testing for inhalation and nasal spray products, and is particularly interested in advancing the technology to find a faster and reproducible method for drugparticle sizing relative to bioequivalence
studies for nasal spray suspensions.
ChemImage's laboratory services utilize the Falcon II system to enable generic drug developers to obtain drug particle sizing of nasal spray suspension, something drug makers have been unable to achieve in the past a= s part of bioequivalence
The Clinical Pharmacology Unit carries out Bioequivalence
studies meeting international regulatory requirements like USFDA (USA), ANVISA (Brazil), AFSSAPS (France) and WHO (World Health Organization, Geneva) and has successfully cleared their audits.
study, being conducted at Swiss Pharma in Basel, Switzerland, is intended to determine a comparable dose range for Chelsea's new disodium composition of CH-1504 and will consist of escalating oral doses of CH-1504 administered in cohorts of healthy male volunteers.
Nasal sprays in solution can have their bioequivalence
proven solely through in vitro tests, but nasal sprays in suspension frequently require clinical and pharmacokinetic studies.
Leaders in the field of psychopharmacology are receiving widespread anecdotal reports that generic versions of fluoxetine may have diminished bioequivalence
, compared with brand name Prozac, said Dr.