Guidance for industry : stability testing of new biotechnological/biological veterinary medicinal products.
| Corporate Author: | Center for Veterinary Medicine (U.S.) |
|---|---|
| Format: | Government Document eBook |
| Language: | English |
| Published: |
Rockville, MD :
U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine,
[2001]
|
| Subjects: | |
| Online Access: | https://purl.fdlp.gov/GPO/LPS114654 |
Similar Items
Guidance for industry : stability testing, photostability testing of new veterinary drug substances and medicinal products.
Published: (1999)
Published: (1999)
Guidance for industry : stability testing of new veterinary dosage forms.
Published: (1999)
Published: (1999)
Guidance for industry : stability testing of new veterinary drug substances and medicinal products (revision).
Published: (2007)
Published: (2007)
Guidance for industry : stability testing for medicated premixes.
Published: (2000)
Published: (2000)
Guidance for industry : Q1A(R2) stability testing of new drug substances and products.
Published: (2003)
Published: (2003)
Guidance for industry : Q1D bracketing and matrixing designs for stability testing of new drug substances and products.
Published: (2003)
Published: (2003)
Quality of biotechnological products : stability testing of biotechnological/biological products.
Published: (1996)
Published: (1996)
Guidance for industry : Q1E evaluation of stability data.
Published: (2004)
Published: (2004)
Guidance for industry : Q1B photostability testing of new drug substances and products.
Published: (1996)
Published: (1996)
Guidance for industry : Q6B specifications : test procedures and acceptance criteria for biotechnological /biological products.
Published: (1999)
Published: (1999)
Guidance for industry : changes to an approved application for specified biotechnology and specified synthetic biological products.
Published: (1997)
Published: (1997)
Guidance for industry : Q1C stability testing for new dosage forms.
Published: (1996)
Published: (1996)
Guidance for industry : expiration dating and stability testing of solid oral dosage form drugs containing iron.
Published: (1997)
Published: (1997)
Guidance for industry : studies to evaluate the safety of residues of veterinary drugs in human food, carcinogenicity testing.
Published: (2006)
Published: (2006)
Guidance for industry : nonclinical safety evaluation of drug or biologic combinations.
Published: (2006)
Published: (2006)
Guidance for industry : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.
Published: (1995)
Published: (1995)
Guidance for industry : Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process.
Published: (2005)
Published: (2005)
Guidance for industry : safety studies for veterinary drug residues in human food, reproduction toxicity testing.
Published: (2006)
Published: (2006)
Molecular biology and biotechnology.
Published: (2009)
Published: (2009)
Guidance for industry : impurities, residual solvents in new veterinary medicinal products, active substances and excipients.
Published: (2001)
Published: (2001)
Pharmaceutical stability testing to support global markets /
Published: (2010)
Published: (2010)
Guidance for industry : drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals.
Published: (2002)
Published: (2002)
Guidance for industry : impurities in new veterinary drug substances (revision).
Published: (2007)
Published: (2007)
Guidance for industry : pharmacovigilance of veterinary medicinal products : management of periodical summary update reports (PSUs).
Published: (2001)
Published: (2001)
Guidance for industry : process validation, general principles and practices.
Published: (2008)
Published: (2008)
Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products.
Published: (2008)
Published: (2008)
Guidance for industry : pharmacovigilance of veterinary medicinal products, management of adverse event reports (AER's).
Published: (2006)
Published: (2006)
Guidance for industry : environmental impact assessments (EIA's) for veterinary medicinal products (VMP's)-phase 1.
Published: (2001)
Published: (2001)
Stability and stabilization of biocatalysts : proceedings of an international symposium organized under auspices of the Working Party on Applied Biocatalysis of the European Federation of Biotechnology, the University of Cordoba, Spain, and the Spanish Society of Biotechnology, Cordoba, Spain, April 19-22, 1998 /
Published: (1998)
Published: (1998)
Guidance for industry : Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.
Published: (1998)
Published: (1998)
Addendum to ICH S6 : preclinical safety evaluation of biotechnology-derived pharmaceuticals.
Published: (2009)
Published: (2009)
Guidance for industry : S1B testing for carcinogenicity of pharmaceuticals.
Published: (1997)
Published: (1997)
Guidance for industry : S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals.
Published: (1997)
Published: (1997)
Guidance for industry : pre-approval information for registration of new veterinary medicinal products for food-producing animals with respect to antimicrobial resistance.
Published: (2004)
Published: (2004)
Veterinary price-list of pharmaceutical and biological productss /
Published: (1912)
Published: (1912)
Current pharmaceutical biotechnology.
Published: (2000)
Published: (2000)
Guidance for industry : investigating out-of-specification test results (OOS) for pharmaceutical production.
Published: (2006)
Published: (2006)
Guidance for industry : photosafety testing.
Published: (2003)
Published: (2003)
Guidance for industry : dosage and administration section of labeling for human prescription drug and biological products, content and format.
Published: (2007)
Published: (2007)
Guidance for industry : E 11 clinical investigation of medicinal products in the pediatric population.
Published: (2000)
Published: (2000)