Orange Book Evaluations

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]) ... 

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]). 

The Bureau of Competition and Policy Planning Staff of the Federal Trade Commission ( FTC ) submit this Citizen Petition to the Commissioner of Food and Drugs pursuant to 21 C.F.R. 10.25(a) and 10.30 concerning certain issues relating to patent listings in the FDA s Approved Dmg Produets with Therapeutic Equivalence Evaluations (the Orange Book ). We request that the FDA clarify these issues, on an expedited basis, via industry guidanee or other means that the FDA considers appropriate. 

In an effort to codify bioequivalence information, the FDA publishes Approved Drug Products With Therapeutic Equivalence Evaluations, with monthly supplements, commonly called "the Orange Book." The book contains listings of multisource products in one of two categories Products coded "A" are considered bioequivalent to all other versions of that product with a similar "A" coding. Products not considered bioequivalent are coded "B." Of the approximately 8000 products listed, 90% are coded "A."... 

Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations and any current supplement to the publication. 

The Electronic Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations. US Department of Health and Human Services, PubUc Health Service, Food and Dmg Administration, Center for Dmg Evaluation and Research (CDER), Office of Information Technology, Division of Data Management and Services. http //www. fda.gov/cder/ob/default.htm... 

Bioequivalence studies are the basis for determination of the therapeutic equivalence between a pharmaceutically equivalent generic drug product and a corresponding reference hsted drug. This hst is provided in the book titled Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. °... 

The reference standard in a bioequivalence study is a formulation currently marketed with an approved full NDA, for which there are valid scientific safety and efficacy data. The list of reference products is provided in the Orange Book ( Approved Drug Product with Therapeutic Equivalence Evaluations ). The reference product is usually the innovator s brand-name product. The total content of the active drug substance in the test product must be within 5% of the reference product. Usually similar routes of administration are used for the test and reference products unless an alternative route is needed to answer specific pharmacokinetic questions. In some cases the reference material could be a solution, suspension, IV product, or the clinical trial material containing the same quantity of active drug ingredient. 

Center for Drug Evaluation and Research Electronic Orange Book. U.S. Food and Drug Administration Web site, www.fda.gov/cder/ob. Accessed December 15, 2006. 

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