Guidance for Industry - Content and Format of Chemistry, Manufacturing and...
...This section should contain information on the stability of the drug substance and any in-process material at.....This section of the guidance refers to drug substances derived from another drug substance or intermediate through chemical or.....Verification of the stability of the drug substance under the conditions described should..
http://www.fda.gov/cber/gdlns/cmcvacc.htm (score=100)

Chem Revs. of DMFs for DSIs
...Summarize the data showing that the container/closure system is compatible with the drug.....If a stability-indicating test is used which is different from the release test, this.....the bioavailability of the drug products made from the substance, including, for example,specifications relating to..
http://www.fda.gov/cder/mapp/5015-4.pdf (score=92)

MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....manufacturing, processing, packaging, controls, stability testing, or labeling operations.....of each facility involved in the manufacturing of the drug substance and excipients should..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=37)

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.....changed container and closure system in stability studies using the..approved stability..
http://www.fda.gov/cder/guidance/cmc1.pdf (score=32)

Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug...
...2 The term drug substance, which is used throughout the text, is intended to include biological.....The mAb manufacturer should perform real-time stability studies of unconjugated and.....the potential impact on the biological safety, quality, and purity of the drug substance and/or..
http://www.fda.gov/cber/gdlns/mab032901.pdf (score=31)

GUIDE TO INSPECTIONS OF BULK PHARMACEUTICAL CHEMICALS
...The USP also notes that the impurity profile of a drug substance is a description of the.....This, together with the generally widespread existence of stability testing programs, make.....Related substances are defined as those structurally related to a drug substance such as a..
http://www.fda.gov/ora/inspect_ref/igs/bulk.html (score=31)

stability guidance -draft
...of drug substance placed on stability should be representative of both the quality of the.....this guidance to mean a batch of drug substance or drug product manufactured at the scale.....compromise the quality, purity, or stability of the drug substance and the resulting drug..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=156)

Guidance- Content & Format CMC for Vaccine & Related Product
...A list should be provided of all components in the drug product, including drug substance(s)and other ingredients, with.....This section should contain information on the stability of the drug substance and any in.....material at each holding step, as outlined in "Stability Testing of New Drug Substances..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=154)

J:!GUIDANCFINALICHQ1C.PDF
...Stability protocols for new dosage forms should follow the guidance in the parent.....substance as included in the existing drug product approved by the..pertinent regulatory.....submitted regarding stability of new dosage forms by the owner of the original application..
http://www.fda.gov/cder/guidance/1319fnl.pdf (score=33)

Guidance for Industry Botanical Drug Products
...These regulations require documentation of the drug substance, drug product, placebo, labeling.....The sponsor should develop stability-indicating analytical methods and conduct stability.....one in which the components or ingredients and composition of the drug substance and drug..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=31)

...Stability-indicating analytical methods should be developed to monitor the stability of the drug substance and.....The stability of a botanical drug substance or product generally should not be based entirely on the assay of the active.....These regulations require documentation of the drug substance, drug product, placebo, labeling..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=31)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...A vehicle that optimally delivers one drug substance may be inappropriate for delivery of a.....Factors such as drug stability in the vehicle, the specific product use, and the site of.....Skin temperature and moisture also influence the rate and extent of absorption of the drug..
http://www.fda.gov/cder/fdama/difconc.htm (score=31)

Substance
...individual batches of the drug substance used in animal and clinical testing, Drug Substance.....Stability.. The regulations require a full description of the stability of the drug.....the subsequent bioavailability and stability requirements of the final dosage form. II..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=31)

Guidanc for Industry: Container and Closure Integrity Testing in Lieu of...
...The purpose of stability testing is to provide evidence on how the quality of a substance.....ICH final guideline is intended to supplement the tripartite ICH guideline entitled, "Stability..Testing of New Drug.....microbial barrier, and, hence, the sterility of a drug product throughout its shelf..life..
http://www.fda.gov/cber/gdlns/contain.pdf (score=30)

WAIS Document Retrieval
...Such studies should normally be conducted on the drug product or drug substance containing the degradation.....Degradation products observed in stability studies conducted at recommended storage.....Safety studies should provide a comparison of results of safety testing of the drug product or drug substance..
http://www.fda.gov/cder/guidance/ichq3b.htm (score=30)

HUMAN DRUG CGMP NOTES December, 1996
...The profile of drug substance purity at release, developed over the course of process.....However, because the technology may not have been available, older applications lacking.....Is it acceptable for a firm to use drug components, drug product containers, or drug product closures simultaneously with testing and..
http://www.fda.gov/cder/hdn/cnotesd6.htm (score=30)

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...condition for stability testing of a new drug substance or drug product for a registration.....outlines the stability data package for a new drug substance or drug product that is.....parent guidance can be followed to generate stability data packages for registration..
http://www.fda.gov/cder/guidance/6312fnl.pdf (score=30)

Microsoft Word - 5320.1.doc
...process and validation information for a sterile drug substance is the same as..for a sterile.....2 Post-Approval Stability Protocol and Stability Commitment.. Analytical procedures and testing schedule for.....6 ONLY if the drug substance is sterile or if..other product quality microbiology issues are..
http://www.fda.gov/cder/mapp/5320.1.pdf (score=30)

Microsoft Word - 5020.1.doc
...process and validation information for a sterile drug substance is the same as..for a sterile.....2 Post-Approval Stability Protocol and Stability Commitment.. Analytical procedures and testing schedule for.....6 ONLY if the drug substance is sterile or if..other product quality microbiology issues are..
http://www.fda.gov/cder/mapp/5020.1.pdf (score=30)

Content and Format of INDs for Phase 1 Studies of Drugs, Inclu
...Food and Drug Administration, Center for Drug Evaluation and Research,"IND Process and.....Information to support the stability of the drug..substance during the toxicologic studies.....Information to support the stability of the drug..substance during the toxicologic studies..
http://www.fda.gov/cder/guidance/clin2.pdf (score=30)

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