A key goal in pharmaceutical development of dosage forms is a good understanding of the in vitro and in vivo performance of the dosage forms. One of the challenges of biopharmaceutics research is correlating in vitro drug release information of various drug formulations to the in vivo drug profiles (IVIVC). Thus the need for a tool to reliably correlate in vitro and in vivo drug release data has exceedingly increased. Such a tool shortens the drug development period, economizes the resources and leads to improved product quality. Increased activity in developing IVIVCs indicates the value of IVIVCs to the pharmaceutical industry. IVIVC can be used in the development of new pharmaceuticals to reduce the number of human studies during the formulation development as the main objective of an IVIVC is to serve as a surrogate for in vivo bioavailability and to support biowaivers. It supports and/or validates the use of dissolution methods and specification settings. This is because the IVIVC includes in vivo relevance to in vitro dissolution specifications. It can also assist in quality control for certain scale-up and post-approval changes (SUPAC). With the proliferation of modified-release products, it becomes necessary to examine the concept of IVIVC in greater depth. Investigations of IVIVC are increasingly becoming an integral part of extended release drug development. There must be some in vitro means of assuring that each batch of the same product will perform identically in vivo. This review article represents the FDA guidance, development, evaluation, and validation of an IVIVC to grant biowaivers, and to set dissolution specifications for oral dosage forms, biopharmaceutics classification systems (BCS), BCS biowaivers, application of BCS in IVIVC development and concept of mapping. The importance of dissolution media and methodology and pharmacokinetic studies in the context of IVIVC has been highlighted. The review also covers the literature examples of IVIVCs regarding internal and external validation, compendial dissolution assessment, formulation dependency of IVIVCs, and IVIVCs of pure enantiomers versus racemate drugs. The same principles of IVIVC used for oral extended release products may be applied for non-oral products such as parenteral depot formulations and novel drug delivery systems as well.

/pdf/in-vitro-in-vivo-correlation-from-theory-to-applications-5emn3wlf20.pdf

In vitro - in vivo correlation: from theory to applications.

In vivo methods for drug absorption – Comparative physiologies, model selection, correlations with in vitro methods (IVIVC), and applications for formulation/API/excipient characterization including food effects

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jps.21009

Pharmacokinetics in Drug Discovery

Silicosis — Continued Silicosis is a chronic lung disease associated with the inhalation and pulmonary deposition of dust that contains crystalline silica. Through the Sentinel Event Notification System for Occupational Risks (SENSOR)* program, CDC's National Institute for Occupational Safety and Health (NIOSH) is assessing practical models for implementing state-based surveillance of silicosis and linking follow-up intervention activities to surveillance reports. From 1989 through 1992, the Ohio Department of Health (ODH) SENSOR program identified silicosis cases through reports of Bureau of Workers' Compensation (BWC) claims, physician reports, and death certificates. The addition in 1993 of hospital discharge reports as an ascertainment source resulted in a substantial increase in the number of silicosis case reports identified annually (Table 1). This report describes the investigation of a case of occupational silicosis in Ohio and summarizes the impact of hospital-based reporting on surveillance for silicosis in Case Report In September 1991, a case report † was sent to ODH by an infectious disease specialist who was treating a 55-year-old sandblaster with advanced silicosis and an associated Mycobacterium kansasii infection § (2). In January 1992, NIOSH and ODH conducted a joint investigation at the worker's place of employment—a metal preparation shop—to evaluate current levels of exposure to respirable crystalline silica and to screen co-workers for silicosis. The investigation detected excessive exposures to respirable crystalline silica (2–5). Chest radiology revealed radiographic abnormalities consistent with pneumoconiosis in four of 16 current and former workers *SENSOR is a program of cooperative agreements with state health departments to develop surveillance and intervention strategies for selected occupational conditions. The National Institute for Occupational Safety and Health currently supports SENSOR silicosis programs in seven states and Wisconsin). † Case reports should be submitted for persons with a physician's provisional diagnosis of silicosis, a chest radiograph interpreted as consistent with silicosis, or pathologic findings consistent with silicosis (1).

Current trends in

The solubility of fenofibrate in pH 6.8 McIlvaine buffers containing varying concentrations of sodium lauryl sulfate was determined. The dissolution behavior of fenofibrate was also examined in the...

D.M. Barends

Papers

In vitro/in vivo correlations of dissolution data of carbamazepine immediate release tablets with pharmacokinetic data obtained in healthy volunteers