Electrophysiologic Studies EPS

Imaging studies

Electromyography and nerve conduction velocity studies

AUT00063

AUT00063 develpoed by Autifony Therapeutics, is a novel, orally active small molecule designed to selectively modulate Kv3 potassium channels, which are important in central auditory processing. Pre...

Clinical Trials Phase News

Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will norma...

Generic Bupropion XL Reevaluation Running Behind Schedule

FDA has received data from just one of four bioequivalence studies of 300 mg bupropion extended-release generics it requested by March from sponsors following Impax/Teva’s withdrawal of their generi...

FDA Approving More ANDAs That Use Novel Bioequivalence Methods

OGD officials report on the progress being made in approving generic drugs using more novel and science-based bioequivalence methods than in the past. Officials impart tips on how to submit review-rea...

The AAPS Journal: Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration

Type: Brief Communication“For-cause” inspections are initiated during the review of bioequivalence (BE) data submitted to Abbreviated New Drug Applications when possible scientific misconduct and...

New data shows value of morphologically directed Raman spectroscopy for bioequivalence studies

A new application note on the Malvern Instruments website describes the use of morphologically directed Raman microscopy in assessing the bioequivalence of a generic and innovator drug with a dual act...

Vince & Associates Awarded FDA Contract

Will conduct bioequivalence clinical studies

Use of pharmacogenetics in bioequivalence studies to reduce sample size: an example with mirtazapine and CYP2D6

Morphologically directed Raman spectroscopy supports identification of particles in mixed populations

With the introduction of the Morphologi G3-ID system last year, Malvern Instruments is providing researchers with the ability to apply morphologically directed Raman spectroscopy to a range of differe...

Belfonte recalls some ice cream with peanut butter

By AP staffKANSAS CITY, Mo. - Belfonte Ice Cream is recalling two types of ice cream that contain peanut butter because of the potential of salmonella contamination.

Pharmacodynamic bioequivalence testing.

What is known and Objective:  The assessment of bioequivalence of drugs intended for local action/targeted delivery and with poor systemic absorption presents unique challenges. Approaches such as p...

Investigation on the need of multiple dose bioequivalence studies for prolonged-release generic products.

In the European Union multiple dose bioequivalence studies are required for the approval of generic prolonged-release products, but they are not required by the US-FDA. In order to investigate if the...

Bioequivalence for Topical Products-An Update.

With the exception of topical glucocorticoids, demonstrating bioequivalence between generic and reference topical products entails conducting clinical end-point trials which are both lengthy and expen...

Treatment of seborrheic dermatitis: comparison of sertaconazole 2 % cream versus pimecrolimus 1 % cream.

OBJECTIVE: Seborrheic dermatitis (SD) is an inflammatory skin disorder affecting the scalp, face, and trunk. The treatment of SD is an important issue in dermatology. This study aimed at comparing the...

Current regulatory approaches of bioequivalence testing.

Introduction: Nowadays, reducing medication costs is vital for health care agencies. Prescription of generic drug products can help lower these expenses. A generally accepted assumption is that therap...