MDI and DPI Drug Products
...For MDI and DPI drug products, certain studies should be performed to determine.....manufacturing, processing, packaging, controls, stability testing, or labeling operations.....stability test storage conditions. Additional studies should be performed to characterize..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Guidance In the Manufacture and Clinical Evaluation of In Vitro Tests to...
...Specificity and Sensitivity Studies for Test Kits with a Proposed Labeling for Screening.....potency and stability of the reagents on storage and under cycling conditions should be.....appropriate test samples are obtained for all donations included in a pool and..that all..
http://www.fda.gov/cber/gdlns/hivnas.pdf (score=83)

stability guidance -draft
...Testing for extractables/leachables on stability studies may be appropriate in situations where.....conditions, the test methods are validated and stability-indicating, and all stability.....should be assayed for the chemical content of the preservatives at all appropriate test..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=256)

Packaging
...In these early stages, the IND should also indicate that appropriate stability studies with the appropriate.....A further test to supplement the mouse subchronic systemic test is the procedure for eye.....Samples of a drug that are selected for stability studies should be packaged in the container..
http://www.fda.gov/cder/guidance/package.htm (score=244)

þÿ
...process test and the drug substance test, the acceptance criterion for the in-process test.....should explain the scientific reasons why a stability indicating procedure is not viable.....dissolution or bioavailability of the drug product, and further studies on the drug..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=91)

PTC in Manufacture and Testing of Monoclonal Antibody Products for Human Use
...Results should be correlated closely with studies of conjugate stability.Studies of the immunoconjugate should be.....If no appropriate anti-mAb antibody test is available,a properly validated test system should be developed by the.....Virus clearance studies should be supported by appropriate statistical analysis..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=90)

þÿ
...process test and the drug substance test, the acceptance criterion for the in-process test.....should explain the scientific reasons why a stability indicating procedure is not viable.....dissolution or bioavailability of the drug product, and further studies on the drug..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=90)

...If no appropriate anti-mAb antibody test is available, a properly validated test system should be developed by the.....Depending upon the nature of the components of the immunoconjugate and the stability of the conjugate itself, separate studies of the.....Statistics Virus clearance studies should be supported by appropriate statistical analysis demonstrating that the study..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=90)

...The sponsor should develop stability-indicating analytical methods and conduct stability studies as.....dissolution for solid oral dosage forms, sterility for parenterals, animal safety test for parenterals, when.....Draft protocols for carcinogenicity studies should be submitted to the appropriate review division and the CDER..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=82)

Guidance for Industry: Human Somatic Cell Therapy and Gene Therapy
...21 CFR part 58, it is recognized that studies in support of entry into clinical trials may.....See"Guideline on validation of the limulus amebocyte lysate test as an end-product.....description of the methods used, actual data from appropriate tests, and evidence of assay..
http://www.fda.gov/cber/gdlns/somgene.pdf (score=81)

Q1B Photostability Testing of New Drug Substances and Products
...A systematic approach to photostability testing is recommended covering, as appropriate, studies such.....It may be appropriate to test certain products, such as infusion liquids or dermal creams, to support.....The ICH Harmonized Tripartite Guideline on Stability Testing of New Drug Substances and..
http://www.fda.gov/cder/guidance/1318.htm (score=80)

þÿ
...This guidance first summarizes appropriate nonclinical studies recommended during early.....their method of isolation and their characterization, storage and stability, and cell.....toxicity test related to the drug's particular mode of administration or conditions of use..
http://www.fda.gov/cder/guidance/5518dft.pdf (score=79)

Guidance for Industry: Vaccinia Virus — Developing Drugs to Mitigate...
...A standard test battery of studies has been selected under ICH to evaluate a new drug for its ability to.....This guidance first summarizes appropriate nonclinical studies recommended during early.....stability, and cell culture procedures and materials. Sponsors are encouraged to consult..
http://www.fda.gov/cber/gdlns/vacciniadrugs.htm (score=79)

Points to Consider on the Characterization of Cell Lines Used to Produce...
...If performed by the supplier, indicate if you receive detailed test results or summary.....have performed studies to validate the effectiveness of the procedures. When the.....Points to Consider, "Nucleic Acid Characterization and Genetic Stability.. If a cell line..
http://www.fda.gov/cber/gdlns/ptccell.pdf (score=75)

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