In appendix 16.2.1, there should also be a listing of all patients discontinued from the study after enrolment, broken down by centre and treatment group, giving a patient identifier, the specific reason for discontinuation, the treatment （drug and dose）, cumulative dose, （where appropriate）, and the duration of treatment before discontinuation.〔【出典】ICHガイドライン 〕
The decision tree in Appendix A outlines a stepwise approach to stability data evaluation and when and how much extrapolation can be considered for a proposed retest period or shelf life.〔【出典】ICHガイドライン 〕
Appendix B provides （1） information on how to analyze long-term data for appropriate quantitative test attributes from a study with a multi-factor, full or reduced design, （2） information on how to use regression analysis for retest period or shelf life estimation, and （3） examples of statistical procedures to determine poolability of data from different batches or other factors.〔【出典】ICHガイドライン 〕
Also take note of the supplement at the end of the book, which is a letter that will arrive in the year 2005.〔【出典】Hiragana Times, 2002年7月号◆【出版社】株式会社ヤック企画 〕"HT189050", "2240884"
With 365 kanji characters, their readings and meanings also included in an appendix booklet, you can carry it with you and study it anywhere.〔【出典】Hiragana Times, 2006年8月号◆【出版社】株式会社ヤック企画 〕"HT238009", "2569437"
However, other considerations which may apply to primary cells are discussed further in Appendix 1 of this document.〔【出典】ICHガイドライン 〕
bound-in supplement to the book
Details of the statistical analysis performed on each primary efficacy variable should be presented in an appendix.〔【出典】ICHガイドライン 〕
A CD is included containing conversations and short expressions from the text.〔【出典】Hiragana Times, 2006年9月号◆【出版社】株式会社ヤック企画 〕"HT239009", "2223047"
The tabulation described should usually be included in appendix 16.2.6 of the study report, rather than in the more extensive case report tabulations required by some regulatory authorities, because it represents the basic efficacy data supporting summary tables.〔【出典】ICHガイドライン 〕
The minutes of meetings of any data monitoring group and any data reports reviewed at those meetings, particularly a meeting that led to a change in the protocol or early termination of the study, may be helpful and should be provided in appendix 16.1.9.〔【出典】ICHガイドライン 〕
In other news, the first "national otaku test" was run by Biblos Co., Ltd. （the test was included otaku culture information magazine "magazine elfics"） last August.〔【出典】Hiragana Times, 2005年11月号◆【出版社】株式会社ヤック企画 〕"HT229020", "2362773"
Examples of analytical procedures which may be employed to test for the presence of impurities are listed in Appendix 6.2.〔【出典】ICHガイドライン 〕
For an illustrative example, see Appendix 2.〔【出典】ICHガイドライン 〕
The study report should indicate what material is included as an appendix, what is in the more extensive archival case report tabulations, if required by the regulatory authority, and what is available on request.〔【出典】ICHガイドライン 〕
Specific impurities and technical approaches employed, as in the case of physicochemical characterization, will vary from product to product and alternative approaches, other than those listed in this appendix will be appropriate in many cases.〔【出典】ICHガイドライン 〕
A decision tree is provided in Appendix A as an aid.〔【出典】ICHガイドライン 〕
All adverse events for each patient, including the same event on several occasions should be listed in appendix 16.2.7, giving both preferred term and the original term used by the investigator.〔【出典】ICHガイドライン 〕
Any measurements of compliance of individual patients with the treatment regimen under study and drug concentrations in body fluids should be summarised, analysed by treatment group and time interval, and tabulated in Appendix 16.2.5.〔【出典】ICHガイドライン 〕
The actual protocol and any changes should be included as appendix 16.1.1 and a sample case report form （unique pages only; i.e., it is not necessary to include identical pages from forms for different evaluations or visits） as appendix 16.1.2.〔【出典】ICHガイドライン 〕
The relationship between the process inputs （material attributes and process parameters） and the critical quality attributes can be described in the design space （see examples in Appendix 2）.〔【出典】ICHガイドライン 〕
Examples of useful "model" viruses representing a range of physico-chemical structures and examples of viruses which have been used in viral clearance studies are given in Appendix 2 and Table A-1.〔【出典】ICHガイドライン 〕
There should be a tabular listing of all patients, visits and observations excluded from the efficacy analysis provided in appendix 16.2.3 （see Annex VI of the guideline for an example）.〔【出典】ICHガイドライン 〕