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Abstrak :
The first part of this title contained all statistical tests relevant to starting clinical investigations, and included tests for continuous and binary data, power, sample size, multiple testing, variability, confounding, interaction, and reliability. The current part 2 of this title reviews methods for handling missing data, manipulated data, multiple confounders, predictions beyond observation, uncertainty of diagnostic tests, and the problems of outliers. Also robust tests, non-linear modeling , goodness of fit testing, Bhatacharya models, item response modeling, superiority testing, variability testing, binary partitioning for CART (classification and regression tree) methods, meta-analysis, and simple tests for incident analysis and unexpected observations at the workplace and reviewed. Each test method is reported together with (1) a data example from practice, (2) all steps to be taken using a scientific pocket calculator, and (3) the main results and their interpretation. Although several of the described methods can also be carried out with the help of statistical software, the latter procedure will be considerably slower.

Abstrak :
This new volume in the series focuses on the particular IP issues of therapeutics, vaccines and molecular diagnostics. The first chapter concentrates on basics principles for protecting antibody compounds. Additional ways to create follow-up protection for antibody therapeutics are also discussed. The second chapter gives an overview of the patent landscape in molecular diagnostics, and discusses issues of patentability with respect to the different technologies and compounds used therein. The third chapter gives a broad overview of areas of law that are particularly relevant to the patenting of peptide vaccines and therapeutic peptides as products and in compositions. The scope of patentable subject matter is discussed, as it has been the focus of much wrangling and debate in the courts.