In this work we apply the FDA proposed precision criteria necessary for pediatric pharmacokinetic studies (Wang et. al., 2012) as a stopping criteria for a model based adaptive optimal design (MBAOD) of an adult to children pharmacokinetic bridging study. We demonstrate the power of the MBAOD compared to both traditional designs as well as non-adaptive optimal designs.

BACKGROUND Optimal clinical trial endpoints for irritable bowel syndrome with constipation (IBS-C) are uncertain. OBJECTIVE The objective of this article is to compare adequate relief (AR) to abdominal/bowel symptoms, global endpoints, and FDA and EMA responder criteria; and to use AR as an anchor to assess clinically meaningful change (CMC) in IBS-C symptoms. METHODS Using pooled 12-week d...

BACKGROUND The BP oil spill of 2010 resulted in contamination of one of the most productive fisheries in the United States by polycyclic aromatic hydrocarbons (PAHs). PAHs, which can accumulate in seafood, are known carcinogens and developmental toxicants. In response to the oil spill, the U.S. Food and Drug Administration (FDA) developed risk criteria and established thresholds for allowable l...

BACKGROUND Pain palliation resulting from antitumor therapy provides direct evidence of treatment benefit when combined with evidence of antitumor activity. The US Food and Drug Administration (FDA) previously issued guidance regarding the use of patient-reported outcome (PRO) measures to support labeling claims. The purpose of this article is to identify common challenges and key design strate...

BACKGROUND Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing. METHODS AND FINDINGS Cross-se...

Despite substantial premarket efforts, a significant portion of approved drugs has been withdrawn from the market for safety reasons. The deleterious impact of nonsynonymous substitutions predicted by the SIFT algorithm on structure and function of drug-related proteins was evaluated for 2504 personal genomes. Both withdrawn (n = 154) and precautionary (Beers criteria (n = 90), and US FDA pharm...

Behavioral treatments for obesity are not evaluated by the same criteria as pharmaceutical drugs, even though treatments such as low-calorie dieting are widely prescribed, require patients' time and investment, and may have risks. The Food and Drug Administration (FDA) has a procedure for evaluating drugs, in which drugmakers must answer the following questions: (1) Is the treatment safe? (2) H...

Regulations for ballast water treatment specify limits on the concentrations of living cells in discharge water. The vital stains fluorescein diacetate (FDA) and 5-chloromethylfluorescein diacetate (CMFDA) in combination have been recommended for use in verification of ballast water treatment technology. We tested the effectiveness of FDA and CMFDA, singly and in combination, in discriminating ...

Flood Damage Assessment (FDA) is a key component in modern risk management frameworks providing an effective basis for decision making and the treatment of the risks. Current FDA methods do not consider the distinctiveness of buildings in analysis and therefore, cannot analyse them on a case-by-case basis, which is necessary for a variety of applications like engineering and design evaluation. ...

A quaculture is an important developing international industry. Approved pharmaceutical agents available to veterinarians in the United States are limited in their therapeutic scope and efficacy. Ensuring preharvest food safety and preventing illegal drug residues are extremely important issues in the selection of therapeutic regimens for aquatic species. Currently available therapeutic substan...