This workshop report summarizes the proceedings of Day 2 a three-day on “Current State and Future Expectations Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes Controls”. From drug product quality perspective, physiologically based biopharmaceutics modeling (PBBM) is tool link variations in attributes vivo outcomes enabling establishment clinically re...

I. Introduction The US Food and Drug Administration sets performance limit on dissolution in terms of a specific percentage Q that the drug product is required to be dissolved at a specified time. Based on inferences from correlated bioavailability studies, these dissolution specifications were intended to assure that at least 80% of the labeled quantity of drug was available. When carried out ...

International Perspectives on the Drug Release of Special Dosage Forms This workshop was co-sponsored by FDA and FIP. This kick-off presentation introduced the workshop by providing background and objectives. The workshop focused on modified-release drug forms and included regulatory perspectives and specific presentations for orally disintegrating tablets, chewable oral drug products, ophthalm...

In the pharmaceutical industry, a stability study is usually conducted to establish the drug expiration dating period(or shelf-life) of a drug product. The method suggested in the current FDA guidelines does not consider the situation when there is a batch-to-batch variation. Chow and Shao (1991) proposed a model which can take into account the batch-to-batch variation results. In this paper, a...

This article provides an overview of the patient-specific and drug-specific variables that can affect drug absorption following oral product administration. The oral absorption of any chemical entity reflects a complex spectrum of events. Factors influencing product bioavailability include drug solubility, permeability, and the rate of in vivo dissolution. In this regard, the Biopharmaceutics C...

The purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different suppliers. The target was to design a sufficiently robust drug substance specification allowing t...

a lot of researches have investigated the effects of topical cyclosporine a on the eye surface layers' diseases. by now the main limitation in cyclosporine application is the low permeation of the drug into the posterior segments of the eye. the aim of present study was to formulate high permeable dosage form can be beneficial in the topical treatment of the uveitis. to reach higher corneal dru...

Background For the purpose of understanding the Food and Drug Administration’s (FDA’s) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers.   Methods The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a...