PRODUCT DEFINITION DEFICIENCES IN CLINICAL STUDIES OF HERBAL MEDICINES

• It is used in the traditional manner in terms of therapeutic indication, route and
schedule of administration, and quantities or doses.
For initial clinical studies on a botanical drug product that is not currently lawfully marketed in th[r]

There is a lack of standardized definition for treatment-related mortality (TRM), which represents an important endpoint in cancer. Our objective was to describe TRM definitions used in studies of children, adolescents and young adults with lymphomas, solid tumors and brain tumors.

common occurrences which make it difficult or impossible to properly define the sensitization profile of allergic patients. Indeed, approximately 75% of allergic individuals are poly- sensitized, i.e. they produce IgE reacting with multiple allergen sources (Scala et al., 2010). T[r]

TRAPHACO’s factories were fresh built with the modern design of both productivity and ability to apply the newest technology in production. Until now, Hoang Liet factory is one of the several Vietnamese factories affording GMP-WHO standards.
The company's facilities sy[r]

There has been interest in the potential benefit of vitamin D (VD) to improve breast cancer outcomes. Pre-clinical studies suggest VD enhances chemotherapy-induced cell death.

The advancements in cancer therapy have improved the clinical outcomes of cancer patients in recent decades. However, advanced cancer therapy is expensive and requires good health care systems. For kidney cancer, no studies have yet established an association between clinical outcome and health care[r]

Arthritis Research & Th erapy provides tantalizing data on the eff ects of rituximab in nine patients with diff use cutaneous systemic sclerosis (dcSSc) nonresponsive to cyclophos phamide. A single treatment course induced a consistent and sustained improvement of skin t[r]

Because the Product object implements the INotifyPropertyChanged interface (as described in Chapter 19), any changes are picked up immediately. For example, if you modify the CategoryName property to move a product out of the Tools category, its text in the list[r]

The hemodynamically relevant patent ductus arteriosus in preterm infants is not well defined. Different clinical and echocardiographic parameters are used and the diagnostic accuracy is unknown because of the lack of a gold standard definition.

not certain, to benefit from MAGE-A3 ASCI immuniza- tion (Table 3) [17]. The GS is currently under validation.
The importance of immunostimulatory antibodies in melanoma treatment was demonstrated in clinical trials of anti-CTLA-4. Two anti-CTLA-4 antibodies, ipi[r]

Animal and clinical studies have revealed that hyperglycemia during ischemic stroke increases the stroke’s severity and the infarct size in clinical and animal studies. However, no conclusive evidence demonstrates that acute hyperglycemia worsens post-stroke outcomes and increases infarct size in la[r]

The EuroQol exhibits validity comparable to the SF-36
The EQ-5D is a self-completion tool consisting of four components [28]. The first two parts address HRQL whereas the latter parts address further background information such as occupation, activity, age, sex, education and so on. In