MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....manufacturing, processing, packaging, controls, stability testing, or labeling operations.....conduct and/or complete prescribed studies on production batches of a drug after approval..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

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.....However, drug-drug interaction studies should be conducted between the therapeutic components of the FDC or co.....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=92)

WAIS Document Retrieval
...Stability studies, knowledge of degradation pathways, product development studies, and laboratory.....Such studies should normally be conducted on the drug product or drug substance containing the degradation products to be controlled.....Safety studies should provide a comparison of results of safety testing of the drug product or drug..
http://www.fda.gov/cder/guidance/ichq3b.htm (score=243)

stability guidance -draft
...Stability studies for Drug for Injection products should include monitoring for appearance, clarity.....Significant change for a drug product at the accelerated stability condition and the.....include results from microbial challenge studies performed on the drug product at..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=95)

Packaging
...Samples of a drug that are selected for stability studies should be packaged in the container/clsoure system in which the drug.....It should provide an adequate seal, be compatible with the drug product, and not be a source of.....In these early stages, the IND should also indicate that appropriate stability studies with the..
http://www.fda.gov/cder/guidance/package.htm (score=91)

6003dft.doc
...therefore, real-time concurrent stability studies on the product potentially affected by.....changes and that no adverse impact on the quality, safety, or efficacy of the drug product.....contractual arrangement to produce the intermediates, drug substance, or drug product on..
http://www.fda.gov/cder/guidance/6003dft.pdf (score=91)

Guidance for Industry
...link between the new combination drug product and the drug products whose safety, efficacy, 280.....available long-term stability data,14 plus short-term stress studies under high.....or three-drug fixed dose combination or co-packaged product with combined labeling showing..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04D-0228-GDL0001-6283dft.pdf (score=91)

...FDA will maintain a requirement for reporting data from all ongoing product stability studies including.....Submit two copies of the annual progress report of postmarketing studies to the Food and Drug Administration.....A status report of each postmarketing study of the drug product concerning clinical safety..
http://www.fda.gov/OHRMS/DOCKETS/98fr/103000c.htm (score=90)

IND content and format for Phase 1 studies
...As clinical development of a drug product proceeds,sponsors should discuss the manufacturing.....Information to support the stability of the drug..substance during the toxicologic studies.....manufacture of the investigational drug product,including both those components intended to..
http://www.fda.gov/cder/guidance/phase1.pdf (score=90)

International Conference on Harmonisation; Draft Guidance on Q5E...
...therefore, real-time concurrent stability studies on the product potentially affected by.....changes and that no adverse impact on the quality, safety, or efficacy of the drug product.....contractual arrangement to produce the intermediates, drug substance, or drug product on..
http://www.fda.gov/cber/gdlns/ichcompbio.pdf (score=90)

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.....entity or is produced by a novel process, and when drug development plans are unusually..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=89)

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=89)

...The conditions under which product stability is evaluated and the positive and negative controls.....Sponsors should study a number of separate product lots during drug development to demonstrate that a safe and.....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=88)

Draft Guidance: ICH Q5E: Comparability of Biotechnological/Biological...
...Generally, therefore, real-time concurrent stability studies on the product potentially affected by the change.....The tests and analytical procedures chosen to define drug substance or drug product specifications alone are.....Furthermore, stability studies might be able to detect subtle differences that are not readily..
http://www.fda.gov/cber/gdlns/ichcompbio.htm (score=88)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...2 The general term product as used in this guidance means drug substance, drug product, and intermediate, or in.....In a comparability protocol we recommend that you include a plan for the stability studies that will.....CMC changes on the identity, strength, quality, purity, and potency of a specific drug product..
http://www.fda.gov/OHRMS/DOCKETS/98fr/protcmc.pdf (score=87)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...2 The general term product as used in this guidance means drug substance, drug product, and intermediate, or in.....In a comparability protocol we recommend that you include a plan for the stability studies that will.....CMC changes on the identity, strength, quality, purity, and potency of a specific drug product..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=86)

Document
...foreign marketing developments with treatment use under a treatment pro-the drug during.....In general, protocols for group to be used, if any, and a descrip-Phase 1 studies may be.....drug product and those which with additional information pertinent ..may not appear but which..
http://www.fda.gov/cber/ind/21cfr312.pdf (score=86)

Guidance for Industry Botanical Drug Products
...These regulations require documentation of the drug substance, drug product, placebo, labeling, and an.....The sponsor should develop stability-indicating analytical methods and conduct stability studies as.....one in which the components or ingredients and composition of the drug substance and drug product are kept..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=86)

...For initial clinical studies on a botanical drug product that is not currently lawfully marketed in the United States.....The sponsor should develop stability-indicating analytical methods and conduct stability.....The stability of a botanical drug substance or product generally should not be based entirely on the assay of the active constituents..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=85)

Q1B Photostability Testing of New Drug Substances and Products
...The extent of drug product testing should be established by assessing whether or not acceptable.....The ICH Harmonized Tripartite Guideline on Stability Testing of New Drug Substances and.....These studies, which may be undertaken in the development phase normally on the drug..
http://www.fda.gov/cder/guidance/1318.htm (score=85)

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