U.S. Department of Health & Human Services

NLM Digital Collections

Search

Search Constraints

Start Over You searched for: Formats Text Remove constraint Formats: Text Collections Health Policy and Services Research Remove constraint Collections: Health Policy and Services Research Copyright Public domain Remove constraint Copyright: Public domain Subjects United States. Department of Health and Human Services. Remove constraint Subjects: United States. Department of Health and Human Services. Subjects International Cooperation Remove constraint Subjects: International Cooperation Genre Technical Report Remove constraint Genre: Technical Report
Number of results to display per page

Search Results

1. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)

nlm:nlmuid-101712951-pdf

4. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 1(R1) : residue on ignition/sulphated ash general chapter

nlm:nlmuid-101713272-pdf

5. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 2(R1) : test for extractable volume of parenteral preparations general chapter

nlm:nlmuid-101713277-pdf

6. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 3(R1) : test for particulate contamination : subvisible particles general chapter

nlm:nlmuid-101713281-pdf

7. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4A(R1) : microbiological examination of nonsterile products : microbial enumeration tests general chapter

nlm:nlmuid-101713288-pdf

8. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4B(R1) : microbiological examination of nonsterile products : tests for specified microorganisms general chapter

nlm:nlmuid-101713291-pdf

9. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4C(R1) : microbiological examination of nonsterile products : acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use general chapter

nlm:nlmuid-101713296-pdf

10. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 5(R1) : disintegration test general chapter

nlm:nlmuid-101713299-pdf

11. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 9(R1) : tablet friability general chapter

nlm:nlmuid-101713302-pdf

12. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 10(R1) : polyacrylamide gel electrophoresis general chapter

nlm:nlmuid-101713306-pdf

13. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 8 (R1) : sterility test general chapter

nlm:nlmuid-101713430-pdf

14. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers

nlm:nlmuid-101734070-pdf

16. E11(R1) addendum: clinical investigation of medicinal products in the pediatric population

nlm:nlmuid-101734090-pdf