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

Drugs and the FDA : safety, efficacy, and the public's trust
紙図書
Mikkael A. SekeresThe MIT Press[2022]<AU-541-D10>
国立国会図書館全国の図書館
  • 件名...Administration Drug approval--United States Drug Approval United States Government Agen...

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

Pharmaceutical economics and policy : perspectives, promises, and problems Third edition.
紙図書
Stuart O. Schweitzer and Z. John Lu.Oxford University Press[2018]<DL533-B56>
国立国会図書館
  • 内容細目...ent protection Drug approval process in the United States ...
  • 件名Economics, Pharmaceutical Public Policy Drug Industry Marketing--economics Drug Approval

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

Innovation in clinical trial methodologies : lessons learned during the Corona pandemic
紙図書
edited by Peter SchülerAcademic Press[2021]<SD61-D2>
国立国会図書館
  • 件名...ic Drug Design Drug Approval Clinical trials. Drugs--Testi...

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)
紙図書
edited by Anurag Rathore, Gail Sofer.CRC Pressc2012.<SD81-B43>
国立国会図書館
  • 件名Biopharmaceutics. 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.
紙図書
Wiley-Blackwell2009.<SD21-B14>
国立国会図書館
  • 件名Pharmacology, 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.
紙図書
Birkhäuserc2009.<M112-B5>
国立国会図書館
  • 件名Drug Approval -- organization & administrat...

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

Pharmacokinetics in drug development / Peter L. Bonate, Danny R. Howard.
紙図書
Springer/aapspressc2011-<SD71-B42>
国立国会図書館
  • 件名...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)
紙図書
伊東雅夫 著サイエンス&テクノロジー2020.12<A581-M13>
国立国会図書館全国の図書館
  • 典拠情報（件名/「を見よ」参照）新薬申請 医薬品承認 医薬品申請 Drug approval

【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
紙図書
技術情報協会 企画編集技術情報協会2019.3<A581-M6>
国立国会図書館全国の図書館
  • 典拠情報（件名/「を見よ」参照）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)
紙図書
edited by Manuel Hidalgo ... [et al.].Springerc2011.<SC471-B36>
国立国会図書館
  • 件名...ials as Topic. Drug Approval. Neoplasms--drug therapy. Ant...

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
紙図書
サイエンス&テクノロジー2018.1<A581-L30>
国立国会図書館全国の図書館
  • 典拠情報（件名/「を見よ」参照）新薬申請 医薬品承認 医薬品申請 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)
紙図書
ヒューマンサイエンス振興財団2018.5<A581-L34>
国立国会図書館
  • 典拠情報（件名/「を見よ」参照）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.
紙図書
Wileyc2008.<SD81-B20>
国立国会図書館
  • 件名...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
紙図書
Mark Chang ... [et al.]CRC Press, c20192019
全国の図書館
  • 件名Clinical Trials as Topic Statistics as Topic Research Design Drug Approval
  • 件名（識別子）Clinical Trials as Topic Statistics as Topic Research Design 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
紙図書
サイエンス&テクノロジー2016.11<A581-L23>
国立国会図書館全国の図書館
  • 典拠情報（件名/「を見よ」参照）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
紙図書
Stuart O. Schweitzer and Z. John LuOxford University Pressc2018
全国の図書館
  • 件名Economics, Pharmaceutical Public Policy Drug Industry Marketing -- economics Drug Approval
  • 件名（識別子）Economics, Pharmaceutical Public Policy Drug Industry Marketing -- economics Drug Approval

Frances Oldham Kelsey, the FDA, and the battle against thalidomide

Frances Oldham Kelsey, the FDA, and the battle against thalidomide
紙図書
Cheryl Krasnick WarshOxford University Press[2024]<SD71-D15>
国立国会図書館
  • 件名...tes--Biography Drug approval--United States--History Thali...

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
マイクロ図書
2003<YCA-Y 4.C 73/8:108-43>
国立国会図書館
  • 件名Ephedra -- Side effects Drug approval -- United States Dietary supp...

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

Preparation of drug submissions : comparative bioavailability studies. (Therapeutic Products Directorate guidelines)
紙図書
Therapeutic Products Directorate, Health Canada1997.<Y629-98-170>
国立国会図書館
  • 件名Pharmacology. Drug Approval. Biological Availability. Can...

Off-label prescribing : justifying unapproved medicine : cloth

Off-label prescribing : justifying unapproved medicine : cloth
紙図書
David CavallaWiley Blackwell2015
全国の図書館
  • 件名Off-Label Use Drug Approval Pharmaceutical Preparations
  • 件名（識別子）Off-Label Use Drug Approval Pharmaceutical Preparations
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