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 〕
In appendix 16.2.2, individual patients with these protocol deviations should be listed, broken down by centre for multicentre studies.〔【出典】ICHガイドライン 〕
付録1でこれらの手法の想定される相違点を比較する。
An illustration of the potential contrasts of these approaches is shown in Appendix 1.〔【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"
365の漢字は、読み方と意味が付録のブックレットに収録されているので、携帯し、どこでも復習できる。
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"
しかし、初代培養細胞に適用可能と思われる留意事項については、本文書の付録1に記載されている。
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 〕
その本の綴じ込み付録
bound-in supplement to the book
それぞれの主要な有効性の変数について実施した統計解析の詳細を付録に示すこと。
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 〕
また、付録のCDにはテキストに出てくる会話文や短い表現が1枚に収録されている。
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"
不純物に関する試験に用いられる分析方法を、付録6.2項に例示する。
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 〕
事例については付録2を参照されたい。
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 〕
参考としてフローチャートを付録Aに示す。
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 〕
In this latter case, special considerations apply and additional information on testing cells propagated in vivo is contained in Appendix 1.〔【出典】ICHガイドライン 〕
Data for these attributes are therefore amenable to the type of statistical analysis described in Appendix B, including linear regression and poolability testing.〔【出典】ICHガイドライン 〕
技術付録
technical appendix
数学的付録
mathematical appendix
数種類の特殊索引と付録が付いている
contain specially designed indices and appendices
文書付録
document supplement
新聞の別刷り付録
newspaper supplement
時に宝というよりは、付録に近いのではと思うことがある。
Sometimes, I think that children are more like additional baggage than treasures.〔【出典】Hiragana Times, 2002年4月号◆【出版社】株式会社ヤック企画 〕"HT186022", "2454204"
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 〕