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Search results 61

Drugs and the FDA : safety, efficacy, and the public's trust

Drugs and the FDA : safety, efficacy, and the public's trust
Paper図書
Mikkael A. SekeresThe MIT Press[2022]<AU-541-D10>
National Diet LibraryOther Libraries in Japan
  • Subject Heading...Administration Drug approval--United States Drug Approval United States Government Agen...

Innovation in clinical trial methodologies : lessons learned during the Corona pandemic

Innovation in clinical trial methodologies : lessons learned during the Corona pandemic
Paper図書
edited by Peter SchülerAcademic Press[2021]<SD61-D2>
National Diet Library
  • Subject Heading...ic Drug Design Drug Approval Clinical trials. Drugs--Testi...

Pharmaceutical economics and policy : perspectives, promises, and problems Third edition.

Pharmaceutical economics and policy : perspectives, promises, and problems Third edition.
Paper図書
Stuart O. Schweitzer and Z. John Lu.Oxford University Press[2018]<DL533-B56>
National Diet Library
  • Contents...ent protection Drug approval process in the United States ...
  • Subject HeadingEconomics, Pharmaceutical Public Policy Drug Industry Marketing--economics Drug Approval

Process validation in manufacturing of biopharmaceuticals 3rd ed. (Biotechnology and bioprocessing series ; v. 35)

Process validation in manufacturing of biopharmaceuticals 3rd ed. (Biotechnology and bioprocessing series ; v. 35)
Paper図書
edited by Anurag Rathore, Gail Sofer.CRC Pressc2012.<SD81-B43>
National Diet Library
  • Subject HeadingBiopharmaceutics. Biotechnology. Drug Approval. Quality Control.

The textbook of pharmaceutical medicine / edited by John P. Griffin. 6th ed.

The textbook of pharmaceutical medicine / edited by John P. Griffin. 6th ed.
Paper図書
Wiley-Blackwell2009.<SD21-B14>
National Diet Library
  • Subject HeadingPharmacology, Experimental. Drug Approval. Clinical Trials as Topic. Ph...

Targeted regulatory writing techniques : clinical documents for drugs and biologics / edited by Linda Fossati Wood and MaryAnn Foote.

Targeted regulatory writing techniques : clinical documents for drugs and biologics / edited by Linda Fossati Wood and MaryAnn Foote.
Paper図書
Birkhäuserc2009.<M112-B5>
National Diet Library
  • Subject HeadingDrug Approval -- organization & administrat...

Pharmacokinetics in drug development / Peter L. Bonate, Danny R. Howard.

Pharmacokinetics in drug development / Peter L. Bonate, Danny R. Howard.
Paper図書
Springer/aapspressc2011-<SD71-B42>
National Diet Library
  • Subject Heading...ic -- methods. Drug Approval. Drug Evaluation, Preclinical...

バイオ医薬品 (抗体医薬品) CTD-CMC記載の要点 (バイオCTDシリーズ ; 2)

バイオ医薬品 (抗体医薬品) CTD-CMC記載の要点 (バイオCTDシリーズ ; 2)
Paper図書
伊東雅夫 著サイエンス&テクノロジー2020.12<A581-M13>
National Diet LibraryOther Libraries in Japan
  • Authority（Subject Heading/altLabel）新薬申請 医薬品承認 医薬品申請 Drug approval

Principles of anticancer drug development (Cancer drug discovery and development)

Principles of anticancer drug development (Cancer drug discovery and development)
Paper図書
edited by Manuel Hidalgo ... [et al.].Springerc2011.<SC471-B36>
National Diet Library
  • Subject Heading...ials as Topic. Drug Approval. Neoplasms--drug therapy. Ant...

【eCTD、CDISCによる】医薬品承認申請と使用するデータの管理と信頼性確保

【eCTD、CDISCによる】医薬品承認申請と使用するデータの管理と信頼性確保
Paper図書
技術情報協会 企画編集技術情報協会2019.3<A581-M6>
National Diet LibraryOther Libraries in Japan
  • Authority（Subject Heading/altLabel）新薬申請 医薬品承認 医薬品申請 Drug approval

バイオ医薬品のCTD-Q作成 : 妥当性の根拠とまとめ方

バイオ医薬品のCTD-Q作成 : 妥当性の根拠とまとめ方
Paper図書
サイエンス&テクノロジー2018.1<A581-L30>
National Diet LibraryOther Libraries in Japan
  • Authority（Subject Heading/altLabel）新薬申請 医薬品承認 医薬品申請 Drug approval

Development and approval of combination products : a regulatory perspective / edited by Evan B. Siegel.

Development and approval of combination products : a regulatory perspective / edited by Evan B. Siegel.
Paper図書
Wileyc2008.<SD81-B20>
National Diet Library
  • Subject Heading...dministration. Drug approval -- United Stat......United States. Drug Approval -- legislation & jurisprudenc...

Innovative strategies, statistical solutions and simulations for modern clinical trials

Innovative strategies, statistical solutions and simulations for modern clinical trials
Paper図書
Mark Chang ... [et al.]CRC Press, c20192019
Other Libraries in Japan
  • Subject HeadingClinical Trials as Topic Statistics as Topic Research Design Drug Approval
  • Subject Heading (ID)Clinical Trials as Topic Statistics as Topic Research Design Drug Approval

CTD-第2部 (モジュール2) : 品質に関する概括資料のモックアップ (記載例) : 抗体医薬品を対象としたモジュール2.3モックアップ (記載例)

CTD-第2部 (モジュール2) : 品質に関する概括資料のモックアップ (記載例) : 抗体医薬品を対象としたモジュール2.3モックアップ (記載例)
Paper図書
ヒューマンサイエンス振興財団2018.5<A581-L34>
National Diet Library
  • Authority（Subject Heading/altLabel）新薬申請 医薬品承認 医薬品申請 Drug approval

承認申請におけるCTD-Q作成での日本特有の要求事項対応と記載事例

承認申請におけるCTD-Q作成での日本特有の要求事項対応と記載事例
Paper図書
サイエンス&テクノロジー2016.11<A581-L23>
National Diet LibraryOther Libraries in Japan
  • Authority（Subject Heading/altLabel）新薬申請 医薬品承認 医薬品申請 Drug approval

Pharmaceutical economics and policy : perspectives, promises, and problems : hardcover 3rd ed

Pharmaceutical economics and policy : perspectives, promises, and problems : hardcover 3rd ed
Paper図書
Stuart O. Schweitzer and Z. John LuOxford University Pressc2018
Other Libraries in Japan
  • Subject HeadingEconomics, Pharmaceutical Public Policy Drug Industry Marketing -- economics Drug Approval
  • Subject Heading (ID)Economics, Pharmaceutical Public Policy Drug Industry Marketing -- economics Drug Approval

Issues relating to ephedra-containing dietary supplements [microform] : hearings before the Subcommittee on Oversight and Investigations and the Subcommittee on Commerce, Trade, and Consumer Protection of the Committee on Energy and Commerce, House of Representatives, One Hundred Eighth Congress, first session, July 23 and 24, 2003

Issues relating to ephedra-containing dietary supplements [microform] : hearings before the Subcommittee on Oversight and Investigations and the Subcommittee on Commerce, Trade, and Consumer Protection of the Committee on Energy and Commerce, House of Representatives, One Hundred Eighth Congress, first session, July 23 and 24, 2003
Microform図書
2003<YCA-Y 4.C 73/8:108-43>
National Diet Library
  • Subject HeadingEphedra -- Side effects Drug approval -- United States Dietary supp...

Off-label prescribing : justifying unapproved medicine : cloth

Off-label prescribing : justifying unapproved medicine : cloth
Paper図書
David CavallaWiley Blackwell2015
Other Libraries in Japan
  • Subject HeadingOff-Label Use Drug Approval Pharmaceutical Preparations
  • Subject Heading (ID)Off-Label Use Drug Approval Pharmaceutical Preparations

Preparation of drug submissions : comparative bioavailability studies. (Therapeutic Products Directorate guidelines)

Preparation of drug submissions : comparative bioavailability studies. (Therapeutic Products Directorate guidelines)
Paper図書
Therapeutic Products Directorate, Health Canada1997.<Y629-98-170>
National Diet Library
  • Subject HeadingPharmacology. Drug Approval. Biological Availability. Can...

The textbook of pharmaceutical medicine 7th ed.

The textbook of pharmaceutical medicine 7th ed.
Paper図書
edited by John P. Griffin, John Posner, Geoffrey R. BarkerWiley-Blackwell2013
Other Libraries in Japan
  • Subject HeadingDrug Approval Clinical Trials as Topic Phar...
  • Subject Heading (ID)Drug Approval Clinical Trials as Topic Phar...