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Medicinal Products Lifecycle
  1. Discovery
  2. Preclinical
  3. Clinical
  4. Dossier
  5. Authorities
  6. Approval
  7. Manufacturing
  8. Export & Import
  9. Pricing & Reimburcement
  10. Marketing
  11. Postmarketing
  12. Reevaluation & Reexamination
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Medicinal Products Lifecycle 7. Manufacturing

Revision of the Guideline on the Impurities in the Medicinal Products with New Active Ingredients

 
Revision of the Guideline on the Impurities in the Medicinal Products with New Active IngredientsQuantity in Basket:none
Code: 7_D_K002
Price:$175.00

 
 
 
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18-page document. Contains the full translation into English of the MHLW, Pharmaceutical and Food Safety Bureau, Evaluation and Licensing Division Notification No. 0624001 dated June 24, 2003, and the text of the ICH Q3B(R) Guideline with added remarks by the Japanese authorities. Translated, indexed and annotated. Copyright ゥ JKS LLC 2003.


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Type: Key document