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=100)

...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=98)

WAIS Document Retrieval
...Stability studies, knowledge of degradation pathways, product development studies, and laboratory.....If data are not available to qualify the proposed specification level of a degradation product.....Degradation products observed in stability studies conducted at recommended storage..
http://www.fda.gov/cder/guidance/ichq3b.htm (score=97)

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=38)

Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products...
...15 Sponsors should evaluate the stability of the drug product in the actual dispensing package as well as in any.....Data would typically include limited accelerated and available long-term stability data,14 plus short-term stress studies under.....Sponsors should evaluate the stability of the drug product in the actual dispensing package as well as in any..
http://www.fda.gov/oc/initiatives/hiv/hivguidance.html (score=35)

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=35)

Guidance for Industry
...available long-term stability data,14 plus short-term stress studies under high.....2 For the purposes of this guidance, a co-packaged product consists of two or more.....For additional details about food-effect bioavailability studies and fed bioequivalence..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04D-0228-GDL0001-6283dft.pdf (score=35)

6672dft.doc
...safety and efficacy, bioavailability, bioequivalence, or primary stability batches and the.....establish an in vitro/in vivo correlation the results of those studies, and a cross.....determine the applicability of this guideline for a particular type of product, applicants..
http://www.fda.gov/cder/guidance/6672dft.pdf (score=97)

ICH; Draft Guidance on Q8 Pharmaceutical Development
...The information and knowledge gained from pharmaceutical development studies provide.....To determine the applicability of this guideline for a particular type of product.....The discussion should cross-reference any relevant stability data in 3.2.P.8.3. A summary..
http://www.fda.gov/cber/gdlns/ichq8pharm.htm (score=97)

Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls...
...Constitution or dilution studies performed as part of formal stability studies to confirm product quality through shelf.....Constitution or dilution studies performed as part of formal stability studies to confirm product quality through shelf.....Data from drug product studies to investigate the potential effect of and the appropriateness of..
http://www.fda.gov/cber/gdlns/drugcmc.htm (score=97)

...Chemical Substances describes some of the circumstances in which drug product studies are.....The discussion should cross-reference any relevant stability data in 3.2.P.8.3. A summary.....1 Components of the Drug Product 5 2.1.1 Drug Substance 5 2.1.2 Excipients 5 2.2 Drug..
http://www.fda.gov/cder/guidance/6672dft.doc (score=96)

International Conference on Harmonisation; Draft Guidance on Q8...
...safety and efficacy, bioavailability, bioequivalence, or primary stability batches and the.....establish an in vitro/in vivo correlation the results of those studies, and a cross.....determine the applicability of this guideline for a particular type of product, applicants..
http://www.fda.gov/cber/gdlns/ichq8pharm.pdf (score=96)

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=37)

IND content and format for Phase 1 studies
...1 Studies of Drugs, Including Well-Characterized, Therapeutic,Biotechnology-derived.....As clinical development of a drug product proceeds,sponsors should discuss the.....methods used to monitor the stability of the drug..product packaged in the proposed..
http://www.fda.gov/cder/guidance/phase1.pdf (score=35)

PTC in Manufacture and Testing of Monoclonal Antibody Products for Human Use
...These trials cannot be used by themselves to support licensure of a product.Studies conducted in.....Results should be correlated closely with studies of conjugate stability.Studies of the immunoconjugate should.....the immunoconjugate and the stability of the conjugate itself, separate studies of the..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=35)

Content and Format of INDs for Phase 1 Studies of Drugs, Inclu
...used to monitor the stability of the drug product packaged in..the proposed container/closure system and storage.....proposed for use in a clinical study to the drug product used in the animal..toxicology studies that support the safety of the.....Information to support the stability of the drug..substance during the toxicologic studies..
http://www.fda.gov/cder/guidance/clin2.pdf (score=35)

...The conditions under which product stability is evaluated and the positive and negative controls.....PRODUCT-RELATED CONSIDERATIONS FOR PHASE 3 STUDIES When planning manufacturing changes or scale-up programs during phase 3 clinical.....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=35)

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=35)

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=35)

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=34)

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