Orange Book

CD-R (CD-recordable) is a writable, nonerasable disk, also called CD-WORM or CD-WO (CD-write once). Permanent marks are produced by a focused laser beam. The definition of the CD-R format and of the erasable—rewritable EOD /MO-R format is put down in the Orange Book (Philips/Sony). 

ANSI/IEEE 446/1995 Recommended practice for emergency and standby power systems for industrial and commercial applications. (IEEE Orange Book) ... 

Electronic Orange Book, Approved Drug Products with Therapeutic Equivalence Evaluations, [Internet]. URL http //www.fda.gov/cder/ob/default.htm, accessed 7-29-2000. 

In general, the evaluation function for quantitative analysis is the inverse of the calibration function y = f(x) (Currie [1995, 1999], IUPAC Orange Book [1987, 1988]) ... 

IUPAC Orange Book (1987) Compendium of analytical nomenclature (eds H. Freiser,... 

IUPAC Orange Book (1988) Compendium of analytical nomenclature (eds J. Inczfidy, J.T. Lengyiel, A.M. Ure, A. Geleneser, A. Hulanicki), Blackwell, Oxford 3rd edn... 

Inczedy J, Lengyiel JT, Ure AM, Geleneser A, Hulanicki A (eds) (1997) Compendium of analytical nomenclature, 3rd edn (IUPAC Orange Book). Blackwell, Oxford... 

IUPAC Orange Book (1997, 2000) printed version Compendium of analytical nomenclature (Definitive Rules 1997) see Inczedy et al. (1997) web version (as from 2000) www.iupac.org/pubhcations/analyticaLcompendium/... 

Depending on the type of relationships between the measured quantity and the measurand (analytical quantity) it can be distinguished (Danzer and Currie [1998]) between calibrations based on absolute measurements (one calibration is valid for all1 on the basis of the simple proportion y = b x, where the sensitivity factor b is a fundamental quantity see Sect. 2.4 Hula-nicki [1995] IUPAC Orange Book [1997, 2000]), definitive measurements (b is given either by a fundamental quantity complemented by an empirical factor or a well-known empirical (transferable) constant like molar absorption coefficient and Nernst factor), and experimental calibration. 

It should be noted that the term sensitivity sometimes may alternatively be used, namely in analytical chemistry and other disciplines. Frequently the term sensitivity is associated with detection limit or detection capability. This and other misuses are not recommended by IUPAC (Orange Book [1997, 2000]). In clinical chemistry and medicine another matter is denoted by sensitivity , namely the ability of a method to detect truly positive samples as positive (O Rangers and Condon [2000], cited according to Trullols et al. [2004]). However, this seems to be more a problem of trueness than of sensitivity. 

Method performance study All laboratories follow the same written protocol and use the same test method to measure a quantity (usually concentration of an analyte) in sets of identical test samples. The results are used to estimate the performance characteristics of the method, which are usually within-laboratory- and between-laboratory precision and - if relevant - additional parameters such as sensitivity, limit of detection, recovery, and internal quality control parameters (IUPAC Orange Book [1997, 2000]). 

Laboratory performance study. Laboratories use the method of their choice to measure one or more quantities on one or more homogeneous and stable test samples in order to assess the performance of the laboratory or analyst. The reported results are compared among themselves, with those of other laboratories, or with the known or assigned reference value, usually with the objective of evaluating or improving laboratory performances (IUPAC Orange Book [1997, 2000]). 

CD-R was something of a surprise invention as, in the late 1980s, most of the major manufacturers in the optical memory area were commercializing the non-standard and relatively expensive WORM media, while focusing their research and development efforts on erasable optical storage. It was also believed that a writeable CD-Audio/CD-ROM-compatible medium was not feasible, due to the high reflectivity needed to meet the CD standard as defined by the Red and Orange Books.196... 

J. Inczedy, T. Lengyel, A. M. Urc, A. Gelencser, and A. Hulanicki. Compendium of Analytical Nomenclature (The Orange Book). 1997. Available at http //www.iupac.org/publications/ analytical compendium/. 

Dangerous goods" is defined in the context of recommended international hazardous material transportation regulations. The UN "Orange Book" should be consulted for further information on the definition of dangerous goods for transportation purposes (UN 2002). 

UN 2002. Recommendations on the Safe Transport of Dangerous Goods ("Orange Book"). Geneva, Switzerland United Nations. 

United Nations 1999. Recommendations on the Transport of Dangerous Goods, Test and Criteria (the Orange Book), 3rd Edition. 

The FDA maintains a database of approved excipients Drug Information Electronic Orange Book, http //www.fda.gov/cder/ob/default.htm). Standards and tests for regulatory acceptable excipients are included in the US Pharmacopoeia and National Formulary. Two such tests, dissolution and stability, are included in Exhibit 5.12 for reference. For new excipients to be included in a drug formulation, they have to satisfy one of the following criteria ... 

Recommendation 1 Permit only one automatic 30-month stay per drug product per ANDA to resolve infringement disputes over patents listed in the Orange Book prior to the filing date of the generic applicant s ANDA. 

Yes. If a brand-name company lists an additional patent in the Orange Book after the generic applicant has filed its AND A, more than one 30-month stay may be generated. The generic applicant is required to re-certify to this later-listed patent, and if, upon notice of the generic s re-certification, the brand-name company sues within 45 days, then FDA approval of the generic s previously filed ANDAis stayed for an additional 30-months from the notice date or until a court decision in the newly instituted patent litigation. 

From 1992 through 2000, brand-name companies have listed patents in the Orange Book after an ANDA has been filed for the drug product in 8 instances 6 of these 8 instances occurred since 1998. For the 8 drug products, the additional delay of FDA approval caused by the additional 30-month stay (beyond the first 30-month stay) ranged from 4 to 40 months. In all 4 of the... 

As a result, there is no mechanism to delist an improperly listed patent from the Orange Book. The laek of such a mechanism may have real world consequences in that the Commission is aware of at least a few instanees in which a 30-month stay was generated solely by a patent that raised legitimate listability questions. 

There have been various suggestions to address this situation, each with its own pros and cons. One proposal has been to establish an administrative procedure through which generic applicants could obtain substantive FDA review of listability. The FDA, however, has taken the position that it lacks the expertise and resources necessary to perform such a review, and its solely ministerial review of Orange Book listings has been upheld by the courts. At a minimum, it appears useful for the FDA to clarify its listing requirements see Appendix H). 

Thus, the usual patent protections would remain for hrand-name companies whose patents may he listed in the Orange Book after the filing of a generic applicant s ANDA solely hecause it took a long time for the Patent Office to issue the patent. 

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