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ガイドライン
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ICH Guidelines
http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
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データベース
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King Guide to Parenteral Admixtures
http://www.kingguide.com/index.html
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データベース
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Stabforum
Stability data for drugs admixed in Baxter devices.
Free - Password required
http://www.stabforum.com
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病院薬局
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Pharmacy of University Hospital of Lausanne, Switzerland
The website of the hospital pharmacy of the University Hospital of Lausanne publishes publications and posters on stability of drugs (in french or english) and many other informations for the hospital pharmacists !
https://www.chuv.ch/fr/pharmacie/pha-home/recherche/posters-et-communications-orales
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病院薬局
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Pharmacy of University Hospital of Geneva (HUG), Switzerland
The website of the hospital pharmacy of the University Hospital of Geneva published publications and posters on stability of drugs and ... many other useful informations for our daily practice (in french or english).
https://pharmacie.hug.ch/
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製薬ジャーナル
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International Journal of Pharmaceutical Compounding
International Journal of Pharmaceutical Compounding is a bimonthly journal which publishes stability studies in each issue.
http://www.ijpc.com/
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データベース
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Trissel’s™ 2 Clinical Pharmaceutics Database
Over 76,500 compatibility results
Results supported by more than 4,700 unique references
https://www.wolterskluwer.com/en/solutions/lexicomp/resources/lexicomp-user-academy/trissels-iv-comp
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ガイドライン
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Stability Data Standard from FDA
For Industry. Stability Data Standard is a Health Level Seven (HL7) standard to facilitate the processing and review of stability data.
https://www.fda.gov/ForIndustry/DataStandards/StabilityDataStandard/default.htm
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ガイドライン
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Methodological guideline for stability studies of hospital pharmaceutical preparation, edition 2013.
This guideline has been written in collaboration between the French Society of Clinical Pharmacy (SFPC) and the Group of Evaluation and Research for protection in areas under control (GERPAC)
https://www.gerpac.net/platform/course/index.php?categoryid=8
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その他のリンク
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British Society for Antimicrobial Chemotherapy (BSCA) Drug stability program
The Drug Stability Testing Programme exists to provide evidence on the stability of agents and devices used in infection management practice, particularly those used in Outpatient Parenteral Antimicrobial Therapy (OPAT).
https://bsac-dsp.com/
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ガイドライン
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ASEAN guideline on stability of drug product.
https://www.asean.org/wp-content/uploads/2018/01/25PPWG-ANNEX-7-iv-Final-ASEAN-Guideline-on-Stabilit
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ガイドライン
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Guideline for the practical stability studies of anticancer drugs: A European consensus conference.
Click on "Stabilité : Guideline 2011" to download the article published in Ann Pharm Fr 2011; 69: 221-231.
https://www.sfpo.com/travaux-publications-sfpo/
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その他のリンク
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French Society of Oncology Pharmacists (SFPO)
The French Society organises every year since 2013 a two-day Masterclass on stability studies in Paris.
https://www.sfpo.com/blog/evenements-sfpo/masterclass/
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薬局方
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Japanese Pharmacopoeia 17th Edition.
Free
https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/0019.html
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薬局方
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The International Pharmacopoeia, Seventh Edition
Free
http://apps.who.int/phint/en/p/docf/
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その他のリンク
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Dynalabs
DYNALABS has developed a support system for hospitals and compounding pharmacies as it pertains to beyond use dating of selective drugs.
http://www.dynalabs.us/what-we-do/hospital-pharmacy/hospital-pharmacies-stability-of-drug/
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ガイドライン
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NHS - Standard protocol for stability assessment. Part 1: Aseptic preparation (small molecules) 5th edition, September 2019
https://www.sps.nhs.uk/wp-content/uploads/2013/12/Stability-part-1-small-molecules-5th-Ed-Sept-19.pd
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ガイドライン
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NHS - A standard protocol for deriving and assessment of stability - Part 3: Oral liquid Medicines (Solutions, Emulsions, Suspensions and Syrups) Edition 1 August 2014.
https://www.sps.nhs.uk/wp-content/uploads/2022/04/NHS-PQA-Standard-Protocol-for-Deriving-and-Assessm
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ガイドライン
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NHS - A Standard protocol for deriving and assessment of stability - Part 2: Aseptic preparations (Biopharmaceuticals) Edition 5, April 2021
https://www.sps.nhs.uk/wp-content/uploads/2017/03/Stability-Part-2-Biopharmaceuticals-v5.pdf
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ガイドライン
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NHS - A Standard protocol for derivation and assessment of stability - Part 4: Parenteral nutrition Edition 1, May 2016.
https://www.sps.nhs.uk/wp-content/uploads/2022/04/NHS-PQA-Standard-Protocol-for-Deriving-and-Assessm
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病院薬局
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Metrodis - Sunnybrook
Metro Toronto Drug Information service publishes the posters of Sunnybrook pharmacy department.
https://metrodis.org/posters-sunnybrook-pharmacy
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製薬ジャーナル
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Pharmaceutical Technology in Hospital Pharmacy (PTHP).
PTHP is an international journal dedicated to all aspects of pharmaceutical technology in hospitals including stability studies and quality control. Free Access
https://www.degruyter.com/view/j/pthp
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製薬ジャーナル
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European Journal of Oncology Pharmacy (EJOP).
EJOP is the official journal of the European Society of Oncology Pharmacy (ESOP). Free access
https://journals.lww.com/ejop/pages/default.aspx
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ガイドライン
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NHS - Standard Protocol for Deriving and Assessment of Stability – Part 5 – Sterile Products (End Sterilised Products) - Edition 1, April 2017
https://www.sps.nhs.uk/wp-content/uploads/2017/06/Stability-part-5-sterile-v1-April-17.pdf
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データベース
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Compounding Today
Compounding Today provides tools and ressources for the professional compounder 'Formulas, Standard Operating Procedures, Physicochemical datas, etc.
https://compoundingtoday.com/
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薬局方
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French Pharmacopoeia
Contains only specific French monographs not included in European Pharmacopoeia. Free on ANSM website
https://www.ansm.sante.fr/Mediatheque/Publications/Pharmacopee-francaise-Plan-Preambule-index
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薬局方
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Brazilian Pharmacopoeia vol 1, 2010
Free
http://portal.anvisa.gov.br/documents/33832/2845829/FBrasileira+Volume+1+INGLES+com+alerta.pdf/f9a34
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