stability guidance -draft
...Historically, all changes in drug product formulation were grouped together and required.....Stability studies for Drug for Injection products should include monitoring for appearance, clarity.....appropriate stability studies, the expiration date assigned to the related finished drug product can..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=100)

MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....an internal reservoir containing sufficient formulation for multiple doses that are.....manufacturing, processing, packaging, controls, stability testing, or labeling operations..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=49)

Human Drug Notes
...65 require that equipment used in processing of a drug product be suitable for its intended use.....drug product, stability studies should be conducted according to an approved stability protocol to.....formulation and processing parameters are adequately studied, evaluated, and documented..
http://www.fda.gov/cder/hdn/hdn1295.htm (score=52)

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.....The identity of the source and a description of the formulation(s), process(es), and..
http://www.fda.gov/cder/guidance/package.htm (score=48)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...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=44)

ichq5c
...guidance to applicants regarding the type of stability studies that should be provided in support of.....either drug substance or drug product should be based on long-term, real-time, real.....1) Where bulk material is to be stored after manufacture, but before formulation and final..
http://www.fda.gov/cder/guidance/ichq5c.pdf (score=42)

...The quality of the final container product placed on stability studies should be representative of the quality of the.....However, it is strongly suggested that studies be conducted on the drug substance and drug product under accelerated.....preliminary assessment of proposed manufacturing changes such as change in formulation..
http://www.fda.gov/cber/gdlns/ichq5c071096.txt (score=42)

Format and Content for the CMC Section of an Annual Report
...the design of stability protocols, the amount of stability data that should be provided to.....Regulatory specifications and analytical methods for the drug substance and drug..product should be listed.....changed container and closure system in stability studies using the..approved stability..
http://www.fda.gov/cder/guidance/cmc1.pdf (score=38)

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=38)

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.....Food and Drug Administration, opportunity for tripartite harmonization.. ionic content..
http://www.fda.gov/cber/gdlns/ichq5c071096.pdf (score=37)

Q1B Photostability Testing of New Drug Substances and Products
...The extent of drug product testing should be established by assessing whether or not acceptable.....These studies are used to identify precautionary measures needed in manufacturing or.....The ICH Harmonized Tripartite Guideline on Stability Testing of New Drug Substances and..
http://www.fda.gov/cder/guidance/1318.htm (score=35)

Federal Register: August 14, 1997 (Volume 62, Number 157
...A citizen petition claiming that a particular drug product is not subject to the new drug.....Stability studies show that levothyroxine sodium exhibits a biphasic first order degradation profile.....Another study estimated that the levothyroxine content of the old formulation was..
http://www.fda.gov/cder/fedreg/fr14au97-83.htm (score=34)

IND Meetings for Human Drugs and Biologics
...Discussion of the relationship between the manufacturing, formulation, and packaging of the drug product used in the phase 3.....Appropriateness of the stability protocols to support phase 3 studies and the planned NDA.....2 The terms investigational new drug or drug as used in this guidance refer to the drug and/or biologic substance and/or product..
http://www.fda.gov/cder/guidance/3683fnl.htm (score=29)

...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 formulation/dosage form of the botanical product used in the proposed phase 3 study..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=27)

Validation of Chromatographic Methods
...Solution stability of the drug substance or drug product after preparation..according to the test method should be evaluated.....Data obtained from studies for robustness, though not usually submitted,are recommended to.....from excipients in the formulation matrix ranging from a simple aqueous..solution to..
http://www.fda.gov/cder/guidance/cmc3.pdf (score=25)

...In general, the drug substance and drug product specifications would be identical to or tighter than those in the.....In a comparability protocol we recommend that you include a plan for the stability studies that will.....certain formulation changes, clinical or nonclinical studies to qualify new impurities..
http://www.fda.gov/cder/guidance/protcmc.doc (score=25)

CBER Approval Letter, Pegfilgrastim (Neulasta), Amgen, Incorporated,...
...The dating period for Pegfilgrastim final drug product shall be 12 months from the date of.....Results of ongoing stability studies should be submitted throughout the dating period, as they.....We acknowledge your written commitments to provide additional information on ongoing studies and to conduct post-marketing..
http://www.fda.gov/cder/foi/appletter/2002/pegfamg013102L.htm (score=24)

...The drug product's formulation provides consistent pharmacokinetic performance between individual dosage.....As part of INDs and NDAs for orally administered drug products, BA studies focus on determining the process.....In each comparison, the new formulation or new method of manufacture is the test product and the prior..
http://www.fda.gov/cder/guidance/5356fnl.doc (score=24)

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.....Therefore, when feasible, active constituents should be identified during phase 3 studies. A single..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=23)

Substance
...individual batches of the drug substance used in animal and clinical testing, Drug.....relation to the amount of crude product, whether it is filtered while hot, whether a.....Stability.. The regulations require a full description of the stability of the drug..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=23)

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