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  1. 1
    Guidance for industry : Q3A impurities in new drug substances.
    Published 2008
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    Government Document Conference Proceeding eBook
  2. 2
    Guidance for industry : S1C(R2) dose selection for carcinogenicity studies.
    Published 2008
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    Government Document Conference Proceeding eBook
  3. 3
    Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.
    Published 2008
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    Government Document Conference Proceeding eBook
  4. 4
    Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Uniformity of Dosage Units, General Chapter.
    Published 2008
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    Government Document Conference Proceeding eBook
  5. 5
    Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Dissolution Test General Chapter.
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    Government Document Conference Proceeding eBook
  6. 6
    Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test General Chapter.
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    Government Document Conference Proceeding eBook
  7. 7
    Guidance for industry : Q4B evaluation and recommendation of pharmocopoeial texts for use in the ICH regions : annex 3 test for particulate contamination, subdivisible particles general chapter.
    Published 2009
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    Government Document Conference Proceeding eBook
  8. 8
    Guidance for industry : Q2B validation of analytical procedures, methodology.
    Published 1996
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    Government Document Conference Proceeding eBook
  9. 9
    Guidance for industry : Q1A(R2) stability testing of new drug substances and products.
    Published 2003
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    Government Document Conference Proceeding eBook
  10. 10
    Guidance for industry : Q3C impurities, residual solvents.
    Published 1997
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    Government Document Conference Proceeding eBook
  11. 11
    Guidance for industry : Q1D bracketing and matrixing designs for stability testing of new drug substances and products.
    Published 2003
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    Government Document Conference Proceeding eBook
  12. 12
    Guidance for industry : Q7A good manufacturing practice guidance for active pharmaceutical ingredients.
    Published 2001
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    Government Document Conference Proceeding eBook
  13. 13
    S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use.
    Published 2008
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    Government Document Conference Proceeding eBook
  14. 14
    Guidance for industry : S8 immunotoxicity studies for human pharmaceuticals.
    Published 2006
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    Government Document Conference Proceeding eBook
  15. 15
    Guidance for industry : S7B nonclinical evaluation of the potential for delayed ventricular repolarization (QT Interval Prolongation) by human pharmaceuticals.
    Published 2005
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    Government Document Conference Proceeding eBook
  16. 16
    Guidance for industry : S7A safety pharmacology studies for human pharmaceuticals.
    Published 2001
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    Government Document Conference Proceeding eBook
  17. 17
    Guidance for industry : S1B testing for carcinogenicity of pharmaceuticals.
    Published 1997
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    Government Document Conference Proceeding eBook
  18. 18
    Guideline for industry : detection of toxicity to reproduction for medicinal products, addendum on toxicity to male fertility.
    Published 1996
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    Government Document Conference Proceeding eBook
  19. 19
    Guidance for industry : E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.
    Published 2005
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    Government Document Conference Proceeding eBook
  20. 20
    Revision of the ICH guideline on clinical safety data management : data elements for transmission of individual case safety reports.
    Published 2005
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    Government Document Conference Proceeding eBook
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