MDI and DPI Drug Products
...An alternative approach may be used if such approach satisfies the requirements of the.....manufacturing, processing, packaging, controls, stability testing, or labeling operations.....For MDI and DPI drug products, certain studies should be performed to determine..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

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.....generic or modular virus clearance studies are used for multiple antibodies that differ only in the.....are used, master vector seed stocks should be generated, and the genetic stability of the..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=99)

...This may be particularly helpful when data from generic or modular virus clearance studies are used.....Plasma may be used instead of serum, provided that the anticoagulant used does not affect the stability of the.....Depending upon the nature of the components of the immunoconjugate and the stability of the conjugate itself, separate studies of the..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=95)

...The sponsor should develop stability-indicating analytical methods and conduct stability studies as.....The clinical data generated from these studies conducted without an IND can be used to support an NDA if the studies were.....Clinical data collected from phase 1 and phase 2 studies conducted without an IND can be used to support a phase 3 study involving..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=81)

stability guidance -draft
...stability studies in accordance with the approved stability protocol on the first production batch.....container and closure integrity testing may be used for other stability testing for that.....These studies are used to identify precautionary measures needed in manufacturing or..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=77)

Points to Consider on the Characterization of Cell Lines Used to Produce...
...Nonreplicating viruses, used as vectors for gene therapy, may be tested in the usual cell.....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=115)

Liquid Chemical Sterilants
...Therefore, stability studies should address the real time stability and dynamics of the formulation.....References to any standards or regulations used as a basis for stability testing should be.....For stability studies supporting the use period of a product after it is opened, unopened containers..
http://www.fda.gov/cdrh/ode/lcgguide.html (score=99)

Guidance for Industry: Human Somatic Cell Therapy and Gene Therapy
...Virus or DNA preparations used as preventive vaccines are not covered by this document.....21 CFR part 58, it is recognized that studies in support of entry into clinical trials may.....developed and product stability should be studied to assure product integrity. In addition..
http://www.fda.gov/cber/gdlns/somgene.pdf (score=95)

þÿ
...same principles for evaluating solid state form can be used, when appropriate, for other.....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=93)

þÿ
...same principles for evaluating solid state form can be used, when appropriate, for other.....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=89)

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