As part of its monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed Bracco Diagnostics Inc.’s (Bracco) website at http://www.impactcin.com (IMPACT website) for its drug product, Isovue (iopamidol injection) (Isovue). The website contains false and unsubstantiated claims related to...

Therapeutic agents, in general, undergo chemical alteration in the body to form derivatives of the parent compound. Isolation and pharmacological assay of the various transformation products may yield valuable information in the Senrch for better therapeutic agents, in studies on the mechanism of drug action :,*d in the elucidation of norm+l metabolic processes. The therapeutic effect of a drug...

OBJECTIVE This study proposed an alternative to brand loyalty as the explanation for the continued price rigidity of patent-expired brand-name prescription drugs despite the increase in market entry of generic drugs facilitated by the 1984 Drug Price Competition and Patent Term Restoration Act. Study hypotheses were to test (1) whether market entries of new-product extensions are associated wit...

Supported by a usage history that predates written records and the perception that "natural" ensures safety, herbal products have increasingly been incorporated into Western health care. Consumers often self-administer these products concomitantly with conventional medications without informing their health care provider(s). Such herb-drug combinations can produce untoward effects when the herb...

The present study was based on the FDA suggested system for humans, according to the Center for Drug Evaluation and Research (CDER) regulates the combination of products has been divided based on the dosage form preparation, that include a product contained two or more drugs that is known as fixed combination according to the section 21 CFR 300.50 [1]. The final product contains two more regula...

Supported by a usage history that predates written records and the perception that “natural” ensures safety, herbal products have increasingly been incorporated into Western health care. Consumers often self-administer these products concomitantly with conventional medications without informing their health care provider(s). Such herb–drug combinations can produce untoward effects when the herb...

The purpose of this paper is to stimulate discussion around the thought processes and activities that occur from creation through development and commercialization of a molecule that ultimately becomes a drug product that benefits patients. This includes exploring the scientific evidence and pharmacological underpinnings that link clinical concepts to drug product design, manufacturing controls...

Molecular oxygen is involved in the propagation step of this reaction, and it is an integral part of the catalytic cycle that generates the oxidative degradation of drug substances in pharmaceutical formulations. Oxidative degradation of the active drug substance in a formulation decreases drug potency and reduces product shelf life (2). The rate of oxidative degradate formation is proportional...

--------------------------------------------------------ABSTRACT----------------------------------------------------------Polymorphism evolved out as a major point of attention for industry as well as regulatory agencies. Many pharmaceutical compounds exist in different crystalline forms and thus exhibit polymorphism. Polymorphism may affect Chemical and Physical Stability, Apparent Solubility,...