stability guidance -draft
...appropriate stability studies, the expiration date assigned to the related finished drug product can.....satisfactory product stability, which may in turn include, but not be limited to, full long-term.....long-term and accelerated stability studies and annual batches thereafter on long-term studies using..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=100)

...FDA will maintain a requirement for reporting data from all ongoing product stability studies including.....FDA's current guidance for industry states that data accumulated from ongoing stability studies.....Name of the applicant, application number, product name, dosage form, product use category, type of study, commitment..
http://www.fda.gov/OHRMS/DOCKETS/98fr/103000c.htm (score=57)

Human Drug Notes
...product, stability studies should be conducted according to an approved stability protocol to.....In the latter case, until appropriate stability data is generated, the expiration date.....65 require that equipment used in processing of a drug product be suitable for its..
http://www.fda.gov/cder/hdn/hdn1295.htm (score=51)

ichq5c
...guidance to applicants regarding the type of stability studies that should be provided in support of.....protein, peptide, inorganic mineral)with the objective of improving the efficacy or stability of the.....formation are detected during long-term, accelerated, and/or stress stability studies,consideration..
http://www.fda.gov/cder/guidance/ichq5c.pdf (score=45)

...The quality of the final container product placed on stability studies should be representative of the quality of the.....The guideline is intended to provide guidance to applicants regarding the type of stability studies.....Where data exist that indicate the stability of a product is not compromised, the applicant is encouraged..
http://www.fda.gov/cber/gdlns/ichq5c071096.txt (score=45)

Draft Guidance: ICH Q5E: Comparability of Biotechnological/Biological...
...Generally, therefore, real-time concurrent stability studies on the product potentially affected by the change.....Furthermore, stability studies might be able to detect subtle differences that are not readily.....The type, nature, and extent of differences between the post-change product and the pre-change product with respect..
http://www.fda.gov/cber/gdlns/ichcompbio.htm (score=39)

ICH: Final Guideline on Stability Testing of Biotechnological/Biological...
...analytical methods for the stability program, reference standards exist, the assay results.....the product retains its full potency, purity, biotechnological/biological products but are.....preclinical and clinical studies, the applicant.. three manufacturing scale batches into..
http://www.fda.gov/cber/gdlns/ichq5c071096.pdf (score=39)

6003dft.doc
...therefore, real-time concurrent stability studies on the product potentially affected by.....knowledge from process development studies, small scale evaluation/validation studies, 331.....evaluated for its impact on stability, since proteins are frequently sensitive to changes..
http://www.fda.gov/cder/guidance/6003dft.pdf (score=33)

International Conference on Harmonisation; Draft Guidance on Q5E...
...therefore, real-time concurrent stability studies on the product potentially affected by.....knowledge from process development studies, small scale evaluation/validation studies, 331.....evaluated for its impact on stability, since proteins are frequently sensitive to changes..
http://www.fda.gov/cber/gdlns/ichcompbio.pdf (score=33)

Packaging
...Samples of a drug that are selected for stability studies should be packaged in the container.....It should provide an adequate seal, be compatible with the drug product, and not be a.....In these early stages, the IND should also indicate that appropriate stability studies with the..
http://www.fda.gov/cder/guidance/package.htm (score=33)

Guidanc for Industry: Container and Closure Integrity Testing in Lieu of...
...testing of drugs, and provides a general indication of the information on product.....intended to provide guidance to applicants regarding the type of stability studies that.....product varies with time under the influence of a variety of environmental factors such as..
http://www.fda.gov/cber/gdlns/contain.pdf (score=27)

Human Drug Notes
...Where an expiration dating period is derived from stability studies conducted on the repackaged drug.....The Division of Manufacturing and Product Quality, HFD-320 Office of Compliance Center for.....The positive product control on routine testing, which must be included during each test..
http://www.fda.gov/cder/hdn/hdn396.htm (score=27)

MDI and DPI Drug Products
...manufacturing, processing, packaging, controls, stability testing, or labeling operations.....For MDI and DPI drug products, certain studies should be performed to determine.....The guidance sets forth information that should be provided to ensure continuing drug..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=21)

Federal Register: August 14, 1997 (Volume 62, Number 157
...Stability studies show that levothyroxine sodium exhibits a biphasic first order degradation profile.....The recall was initiated when the product was found to be below potency at 18-month.....Several studies suggest that subclinical hyperthyroidism in premenopausal women receiving..
http://www.fda.gov/cder/fedreg/fr14au97-83.htm (score=21)

þÿ
...dissolution or bioavailability of the drug product, and further studies on the drug.....should explain the scientific reasons why a stability indicating procedure is not viable.....Stability data to support holding times for intermediates or during processing should also..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=21)

þÿ
...dissolution or bioavailability of the drug product, and further studies on the drug.....should explain the scientific reasons why a stability indicating procedure is not viable.....Stability data to support holding times for intermediates or during processing should also..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=21)

Guidance for Industry
...usually contain a residual product and a commingling of new and old product would result.....provided that they meet appropriate standards or specifications as demonstrated by.....There must be a written testing program designed to assess the stability characteristics..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=21)

ICH; Guidance for Industry Q1D Bracketing and Matrixing Designs for...
...Data variability and product stability, as shown by supporting data, should be considered when a.....A commitment should be provided to carry out stability studies on the marketed extremes postapproval.....When a secondary packaging system contributes to the stability of the drug product, matrixing can be performed..
http://www.fda.gov/cber/gdlns/ichq1d.htm (score=20)

þÿ
...variability and product stability, as shown by supporting data, should be considered when.....With justification, bracketing can be applied to studies with multiple strengths where the.....matrixing to stability studies conducted in accordance with principles outlined in the ICH..
http://www.fda.gov/cber/gdlns/ichq1d.pdf (score=20)

...Generally, therefore, real-time concurrent stability studies on the product potentially affected by the change.....Furthermore, stability studies might be able to detect subtle differences that are not readily.....If differences are observed in the purity and impurity profiles of the post-change product relative to the pre-change product..
http://www.fda.gov/cder/guidance/6003dft.doc (score=20)

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