The development of sound Analytical method(s) is of supreme importance during the process of drug discovery, release to market and development, culminating in a marketing approval. The objective of this paper is to review the method development, optimize and validation of the method for the drug product from the developmental stage of the formulation to commercial batch of the product. Method d...

1 These ingredients are nonmonograph except when used to prepare acidulated phosphate fluoride treatment rinses identified in § 355.10(a)(3) of this chapter. 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved n...

Albumin is one of the most extensively studied endogenous proteins which are used in the fabrication of drug delivery and diagnostic technologies during last 10 years. This review provides a summary of products involving the use of albumin as a drug delivery tool for getting better the pharmacokinetics of a drug by developing the targetted drug delivery systems and diagnosing the pathologies. U...

Natural product compound collections have proven an effective way to access chemical diversity and recent findings have identified phenolic, coumarin, and polyamine natural products as atypical chemotypes that inhibit carbonic anhydrases (CAs). CA enzymes are implicated as targets of variable drug therapeutic classes and the discovery of selective, drug-like CA inhibitors is essential. Just two...

Endotoxin-resistant C3H/HeJ mice were used to test the hypothesis that a macrophage product, possibly interleukin-1, might mediate the depression of liver cytochrome P-450-dependent drug metabolism in endotoxin-treated mice. Depression of liver drug metabolism by endotoxin was observed in normal mice (C3H/HeN) but not in C3H/HeJ mice. Serum transfer experiments demonstrated that a serum factor ...

OBJECTIVE To compare consistency of adverse drug reaction (ADR) data in publicly available product information documents for brand drugs, between the USA and Europe. To assess the usefulness of information for prescribers and patients. DESIGN A comparison review of product information documents for antidepressants and anticonvulsants concurrently marketed by the same pharmaceutical company in...

BACKGROUND In the US, manufacturers seeking approval to market a generic drug product must submit data demonstrating that the generic formulation provides the same rate and extent of absorption as (ie, is bioequivalent to) the innovator drug product. Thus, most orally administered generic drug products in the US are approved based on results of one or more clinical bioequivalence studies. OBJ...

Dissolution testing measures the rate of drug substance release into solution, impacting the extent of drug absorption. Drug manufacturers and regulatory agencies use dissolution testing to identify drug products that do not meet the desired clinical performance. Formulation composition and manufacturing processes can impact the material attributes of a drug product, which directly affect the d...

Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants t...