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Tuesday, 15 June 2021

Penelusuran Basis Data Produk Obat Teregistrasi di Beberapa Negara

Abu Dhabi:
  • https://www.doh.gov.ae/en/resources/drug-search-page
  • https://mohap.gov.ae/en/services/registered-medical-product-directory
Afrika Selatan: https://medapps.sahpra.org.za:6006
Amerika Serikat:
  • FDA Orange Book: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
  • FDA Approved-Drugs: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
  • Pencarian Dokumen Pedoman FDA: https://www.fda.gov/regulatory-information/search-fda-guidance-documents
  • Dokumen Pedoman FDA baru: https://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents
  • Pedoman Uji Bioekivalensi Spesifik-Produk: https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm
  • Metode Disolusi: https://www.accessdata.fda.gov/scripts/cder/dissolution/
  • Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/updated-information-recommended-acceptable-intake-limits-nitrosamine-drug-substance-related
  • Drug Approval Package: pencarian dimulai dengan mengakses Drugs@FDA: FDA-Approved Drugs. Cari nama produk originator. Tautan ke dokumen Drug Approval Package bisa dicari di bagian Approval Date(s) and History, Letters, Labels, Reviews.
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Posted by syx_gf at 20:49 3 comments:
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