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Titles
- Q.--What's the one disease that anyone can develop, is seldom treated, can ruin your health, threatens your job, destroys your family, is sometimes fatal?: A.--Alcoholism1
- Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers1
- Q12 technical and regulatory considerations for pharmaceutical product lifecycle management1
- Q12 technical and regulatory considerations for pharmaceutical product lifecycle management: annexes1
- Q13 continuous manufacturing of drug substances and drug products: guidance for industry1
- Q3C(R8) impurities: guidance for residual solvents1
- Q3C--tables and list1
- Q3D(R1) elemental impurities1
- Q3D(R2) elemental impurities1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 1(R1) : residue on ignition/sulphated ash general chapter1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 10(R1) : polyacrylamide gel electrophoresis general chapter1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 2(R1) : test for extractable volume of parenteral preparations general chapter1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 3(R1) : test for particulate contamination : subvisible particles general chapter1
- 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 chapter1
- 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 chapter1
- 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 chapter1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 5(R1) : disintegration test general chapter1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 8 (R1) : sterility test general chapter1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 9(R1) : tablet friability general chapter1
- Q5A(R2): viral safety evaluation of biotechnology products derived from cell lines of human or animal origin : guidance for industry1