Pattern Approval

Therefore, the first area of investigation is to determine the compliance of an instrument performance with the technical specification of the manufacturer and the standard requirements within pattern approval tests. For this purpose, a metrological procedure is is-... 

According to the Romanian laws and ordinances issued lately in the field of metrology, all the instruments used in public health are subject to pattern approval, to verification or to compulsory calibration. In this framework, the validation work has a special place. 

National Standard M8 Pattern Approval Specifications for Protein Measuring Instruments for Grain, a legal standard for the measurement of grain protein content, has been introduced in Australia. It covers measurements in use for trade, meaning... 

Basically, MAFF requests that the official field residue trials test combinations of each use pattern and formulation type intended for commercialization. Flowever, MAFF may approve/accept data generated by extrapolating the data from one formulation type to certain other types, as shown in Table 2. Some formulation types will be able to extrapolate to the other formulation types. Table 2 shows that the data obtained using the formulation types in the left column can be extrapolated to those of formulation types in the right column. 

One of the most powerful uses of BioPrint is to provide a basis for understanding and learning from past clinical attrition. This is accomplished by systematically prohling historical compounds in the BioPrint assays and using the BioPrint data set as context in which to identify patterns of in vitro activity associated with chemical series, with therapeutic target activity, and with clinical adverse effects. BioPrint allows data from proprietary compounds to be put in context with analogous data on nearly every compound that has succeeded (or not) in getting market approval. 

Topical minoxidil is used for the treatment of male pattern baldness (alopecia androgenetica) of the vertex of the scalp. Use of the tablets, in any formulation, to promote hair growth is not an approved use. 

We used the cumulative number of drugs with NMEs approved and launched in Taiwan to measure pharmaceutical innovations. The annual number of NMEs introduced into Taiwan between 1985 and 2002 followed cyclic patterns (Fig. 13.1). In 1985, 95 NMEs were introduced in this market. This number decreased to 52 and 49 in the next two years, but increased subsequently. In 1995 only 15 NMEs were introduced, possibly reflecting delays in approvals caused by the transition from the then-existing health care financing system to national health insurance in Taiwan in that year. ... 

Some authors have questioned whether there is sufficient efficacy and safety data to support widespread use of the a2-adrenergic agonists (Cantwell et al., 1997), a position which intensified following the report of several sudden deaths of children who were medicated with clonidine and methylphenidate in combination (Popper, 1995). Although the FDA could not establish a causal link between the medications and these catastrophic outcomes, clearly more research is needed. At the same time, interest at the national level in establishing a more extensive scientific database to support the use of previously off-label prescription patterns, and interest on the part of industry to obtain FDA approval for new indications, suggests that larger... 

---