Displaying 1-50 of 78 results
Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Uniformity of Dosage Units, General Chapter.
Web resource
[Rockville, Md.?] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research], [2008]
2008
1 resource
Available online
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.
Web resource
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
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.
Web resource
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
Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Dissolution Test General Chapter.
Web resource
[Rockville, Md.?] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research]
2008
1 resource
Available online
Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test General Chapter.
Web resource
[Rockville, Md.?] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research]
2008
1 resource
Available online
S9 nonclinical evaluation for anticancer pharmaceuticals.
Web resource
[Rockville, Md.?] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research], [2009]
2009
1 resource
Available online
Guidance for industry : S1C(R2) dose selection for carcinogenicity studies.
Web resource
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
E2f development safety update report.
Web resource
[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
Guidance for industry : Q3A impurities in new drug substances.
Web resource
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
Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.
Web resource
[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
Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions.
Web resource
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
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.
Web resource
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
Guidance for industry : Q8 pharceutical development.
Web resource
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
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.
Web resource
[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
Guidance for industry : E15 definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories.
Web resource
Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evalutation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER), [2008]
2008
1 resource
Available online
Q4B, annex 2, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
Web resource
[Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], [2007]
2007
1 resource
Available online
Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 5, disintegration test general chapter.
Web resource
[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
Guidance for industry : M3 nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals.
Web resource
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
Guidance for industry : Q1B photostability testing of new drug substances and products.
Web resource
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
Text on validation of analytical procedures.
Web resource
[Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration], [1995]
1995
1 resource
Available online
Clinical safety data management : definitions and standards for expedited reporting.
Web resource
[Rockville, Md.] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], [1995]
1995
1 resource
Available online
Dose-response information to support drug registration.
Web resource
[Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], [1994]
1994
1 resource
Available online
The extent of population exposure to assess clinical safety : for drugs intended for long-term treatment of non-life threatening conditions.
Web resource
[Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], [1995]
1995
1 resource
Available online
Guidance for industry : M2, eCTD specification, questions & answers and change requests.
Web resource
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
Guidance for industry : E9 statistical principles for clinical trials.
Web resource
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, [1998]
1998
1 resource
Available online
Guidance for industry : E 10 choice of control group and related issues in clinical trials.
Web resource
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
Guidance for industry : Q1C stability testing for new dosage forms.
Web resource
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
Guidance for industry : Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.
Web resource
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, [1998]
1998
1 resource
Available online
Guidance for industry : Q6B specifications : test procedures and acceptance criteria for biotechnological /biological products.
Web resource
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, [1999]
1999
1 resource
Available online
Guidance for industry : Q8(R2) pharmaceutical development.
Web resource
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
Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 10, polyacrylamide gel electrophoresis general chapter.
Web resource
[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
Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 9, tablet friability general chapter.
Web resource
[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
Quality of biotechnological products : analysis of the expression construct in cells used for production of r-DNA derived protein products.
Web resource
[Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], [1996]
1996
1 resource
Available online
Quality of biotechnological products : stability testing of biotechnological/biological products.
Web resource
[Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration], [1996]
1996
1 resource
Available online
Structure and content of clinical study reports.
Web resource
[Rockville, Md] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], [1996]
1996
1 resource
Available online
Studies in support of special populations, geriatrics.
Web resource
[Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Center for Drug Evaluation], [1994]
1994
1 resource
Available online
Guidance for industry : Q1D bracketing and matrixing designs for stability testing of new drug substances and products.
Web resource
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
Pharmacokinetics : guidance for repeated dose tissue distribution studies.
Web resource
[Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration], [1995]
1995
1 resource
Available online
Toxicokinetics : the assessment of systemic exposures in toxicity studies.
Web resource
[Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration], [1995]
1995
1 resource
Available online
Addendum to ICH S6 : preclinical safety evaluation of biotechnology-derived pharmaceuticals.
Web resource
[Rockville, Md.?] : [U.S. Dept. of Health and Human Services, Food and Drug Administration], [2009]
2009
1 resource
Available online
Detection of toxicity to reproduction for medicinal products.
Web resource
[Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration], [1994]
1994
1 resource
Available online
Guidance for industry : S2B genotoxicity, a standard battery for genotoxicity testing of pharmaceuticals.
Web resource
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation : Center for Biologics Evaluation and Research, [1997]
1997
1 resource
Available online
S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use.
Web resource
[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
Guidance for industry. Q3A, Impurities in new drug substances.
Web resource
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
Guidance for industry : Q3B(R2) impurities in new drug products.
Web resource
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
Guidance for industry : Q2B validation of analytical procedures, methodology.
Web resource
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
Guidance for industry : Q1E evaluation of stability data.
Web resource
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
Guidance for industry : Q1A(R2) stability testing of new drug substances and products.
Web resource
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
Guidance for industry : Q3C tables and list.
Web resource
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
Guidance for industry : Q3C impurities, residual solvents.
Web resource
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