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  • Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 2 test for extractable volume of parenteral preparations general chapter.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER), [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110532

  • Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 3 test for particulate contamination, subdivisible particles general chapter.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER), [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110544

  • Guidance for industry : S1C(R2) dose selection for carcinogenicity studies.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; [Rockville, MD] : Center for Biologics Evaluation and Research, [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111012

  • E2f development safety update report.

    • Text
    • [Silver Spring, MD] : [Center for Drug Evaluation and Research] ; [Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111600

  • Guidance for industry : Q3A impurities in new drug substances.

    • Text
    • Sliver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Rockville, MD : Center for Biologics Evaluation and Research, [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111818

  • Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.

    • Text
    • [Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111169

  • Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 5, disintegration test general chapter.

    • Text
    • [Silver Spring, MD] : [Center for Drug Evaluation and Research] ; [Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111591

  • Guidance for industry : E15 definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding catelgories.

    • Text
    • Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER), [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111907

  • Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) : Center for Biologics Evaluation and Research (CBER), [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111972

  • Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions, annex 1, residue on ignition/sulphated ash, general chapter.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) : Center for Biologics Evaluation and Research (CBER), [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111974

  • Guidance for industry : Q8 pharceutical development.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2006]
    • 2006
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112066

  • Q4B, annex 3, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination, sub-visible particles / International Conference on Harrmonisation of Technical Requrements for Registration of Pharmaceuticals for Human Use.

    • Text
    • [Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], [2007]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112085

  • Guidance for industry [electronic resource] : Q3A impurities in new drug substances.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2008]
    • 2008
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113736

  • Guidance for industry [electronic resource] : Q3C tables and list.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2003]
    • 2003
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113804

  • Guidance for industry [electronic resource] : Q3C impurities, residual solvents.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1997]
    • 1997
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113847

  • Guidance for industry [electronic resource] : E2B(M), data elements for transmission of individual case study reports, questions and answers.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005]
    • 2005
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113920

  • Principles for clinical evaluation of new antihypertensive drugs [electronic resource].

    • Text
    • [Rockville, MD? : U.S. Dept. of Health and Human Services, Food and Drug Administration, 2000]
    • 2000
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113966

  • Guidance for industry [electronic resource] : Q3B(R2) impurities in new drug products.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2006]
    • 2006
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113762

  • Guidance for industry [electronic resource] : Q2B validation of analytical procedures, methodology.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1996]
    • 1996
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113764

  • Guidance for industry [electronic resource] : Q9 quality risk management.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2006]
    • 2006
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113766

  • Guidance for industry [electronic resource] : Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005]
    • 2005
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113768

  • Guidance for industry [electronic resource] : Q1E evaluation of stability data.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2004]
    • 2004
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113795

  • Guidance for industry [electronic resource] : Q1A(R2) stability testing of new drug substances and products.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2003]
    • 2003
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113798

  • Guidance for industry [electronic resource] : Q1D bracketing and matrixing designs for stability testing of new drug substances and products.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2003]
    • 2003
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113848

  • Guidance for industry [electronic resource] : Q7A good manufacturing practice guidance for active pharmaceutical ingredients.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2001]
    • 2001
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113849

  • Guidance for industry [electronic resource] : S8 immunotoxicity studies for human pharmaceuticals.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2006]
    • 2006
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113859

  • Guidance for industry [electronic resource] : S7B nonclinical evaluation of the potential for delayed ventricular repolarization (QT Interval Prolongation) by human pharmaceuticals.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005]
    • 2005
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113878

  • Guidance for industry [electronic resource] : S1B testing for carcinogenicity of pharmaceuticals.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1997]
    • 1997
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113890

  • Guidance for industry [electronic resource] : E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005]
    • 2005
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113902

  • Guidance for industry [electronic resource] : E2E pharmacovigilance planning.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005]
    • 2005
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113917

  • Guidance for industry [electronic resource] : E2BM data elements for transmission of individual case safety reports.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2002]
    • 2002
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113934

  • Guidance for industry [electronic resource] : addendum to E2C clinical safety data management : periodic safety update reports for marketed drugs.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2004]
    • 2004
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113936

  • Guidance for industry [electronic resource] : E 10 choice of control group and related issues in clinical trials.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2001]
    • 2001
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113943

  • Guidance for industry [electronic resource] : E 11 clinical investigation of medicinal products in the pediatric population.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2000]
    • 2000
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113969

  • Guidance for industry [electronic resource] : E6 good clinical practice, consolidated guidance.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Control : Center for Biologics Evaluation and Research, [1996]
    • 1996
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113971

  • Guidance for industry [electronic resource] : granularity document : annex to M4, organization of the CTD.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005]
    • 2005
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113972

  • Guidance for industry [electronic resource] : M2 eCTD : electronic common technical document specification.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2003]
    • 2003
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS114300

  • Guidance for industry M2 [electronic resource] : eCTD specification : questions & answers and change requests.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005]
    • 2005
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS114298

  • Guidance for industry [electronic resource] : M4, the CTD, efficacy questions and answers.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2004]
    • 2004
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS114303

  • Guidance for industry [electronic resource] : M4, the CTD, general questions and answers.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2004]
    • 2004
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS114306

  • Guideline for industry [electronic resource] : detection of toxicity to reproduction for medicinal products, addendum on toxicity to male fertility.

    • Text
    • [Rockville, MD : Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 1996]
    • 1996
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113894

  • Post-approval safety data management [electronic resource] : definitions and standards for expedited reporting.

    • Text
    • [Rockville, Md.? : U.S. Dept. of Health and Human Services, Food and Drug Administration, 2003]
    • 2003
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113940

  • Revision of the ICH guideline on clinical safety data management [electronic resource] : data elements for transmission of individual case safety reports.

    • Text
    • [Rockville, MD : Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2005]
    • 2005
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113904

  • S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use [electronic resource].

    • Text
    • [Rockville, MD? : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2008]
    • 2008
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113857

  • Guidance for industry : M2, eCTD specification, questions & answers and change requests.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005]
    • 2005
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS117360

  • Guidance for industry : Q1C stability testing for new dosage forms.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1996]
    • 1996
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS117628

  • Guidance for industry : Q8(R2) pharmaceutical development.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS117887

  • Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 10, polyacrylamide gel electrophoresis general chapter.

    • Text
    • [Rockville, Md.?] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research] : [Center for Biologics Evaluation and Research], [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS117709

  • S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use.

    • Text
    • [Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS113857

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