MDI and DPI Drug Products
...For MDI and DPI drug products, certain studies should be performed to determine.....manufacturing, processing, packaging, controls, stability testing, or labeling operations.....establish a set of criteria to which a drug substance or drug product should conform using..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products...
...However, drug-drug interaction studies should be conducted between the therapeutic components of the FDC or co.....15 Sponsors should evaluate the stability of the drug product in the actual dispensing.....Data would typically include limited accelerated and available long-term stability data,14 plus short-term stress studies under..
http://www.fda.gov/oc/initiatives/hiv/hivguidance.html (score=90)

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...IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the.....Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (I.....Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug..
http://www.fda.gov/cder/guidance/guidlist.pdf (score=89)

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...This guidance first summarizes appropriate nonclinical studies recommended during early.....their method of isolation and their characterization, storage and stability, and cell.....studies has been selected under ICH to evaluate a new drug for its ability to cause..
http://www.fda.gov/cder/guidance/5518dft.pdf (score=137)

Guidance for Industry: Vaccinia Virus — Developing Drugs to Mitigate...
...A sponsor must supply information about the pharmacological and toxicological studies of a drug.....stability, and cell culture procedures and materials. Sponsors are encouraged to consult.....Depending on the drug toxicity, studies in normal human vaccinated volunteers can be considered to..
http://www.fda.gov/cber/gdlns/vacciniadrugs.htm (score=109)

stability guidance -draft
...Stability studies for Drug for Injection products should include monitoring for appearance, clarity.....it is important to consider the results from other formal stability studies to ensure that the drug.....appropriate stability studies, the expiration date assigned to the related finished drug product can..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=96)

6003dft.doc
...therefore, real-time concurrent stability studies on the product potentially affected by.....contractual arrangement to produce the intermediates, drug substance, or drug product on.....knowledge from process development studies, small scale evaluation/validation studies, 331..
http://www.fda.gov/cder/guidance/6003dft.pdf (score=91)

PTC in Manufacture and Testing of Monoclonal Antibody Products for Human Use
...Results should be correlated closely with studies of conjugate stability.Studies of the immunoconjugate should be.....entity or is produced by a novel process, and when drug development plans are unusually.....the immunoconjugate and the stability of the conjugate itself, separate studies of the..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=91)

Packaging
...Samples of a drug that are selected for stability studies should be packaged in the container/clsoure system in which the drug.....In these early stages, the IND should also indicate that appropriate stability studies with the.....Arthur Shaw, Food and Drug Administration, for a Course offered by the Center for..
http://www.fda.gov/cder/guidance/package.htm (score=91)

IND content and format for Phase 1 studies
...As clinical development of a drug product proceeds,sponsors should discuss the.....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/phase1.pdf (score=91)

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=91)

International Conference on Harmonisation; Draft Guidance on Q5E...
...therefore, real-time concurrent stability studies on the product potentially affected by.....contractual arrangement to produce the intermediates, drug substance, or drug product on.....knowledge from process development studies, small scale evaluation/validation studies, 331..
http://www.fda.gov/cber/gdlns/ichcompbio.pdf (score=90)

...Depending upon the nature of the components of the immunoconjugate and the stability of the conjugate itself, separate studies of the.....Department of Health and Human Services Food and Drug Administration Center for Biologics.....Immunoreactivity, Potency and Stability of the Immunoconjugate Coupling of toxin or drug..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=90)

...FDA's current guidance for industry states that data accumulated from ongoing stability studies.....Submit two copies of the annual progress report of postmarketing studies to the Food and Drug Administration.....Therefore, it is clear from existing regulations and guidance that stability studies are..
http://www.fda.gov/OHRMS/DOCKETS/98fr/103000c.htm (score=90)

Guidance for Industry
...available long-term stability data,14 plus short-term stress studies under high.....drug products is currently separately approved, and there are studies owned by one or more.....link between the new combination drug product and the drug products whose safety, efficacy..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04D-0228-GDL0001-6283dft.pdf (score=90)

Draft Guidance: ICH Q5E: Comparability of Biotechnological/Biological...
...Furthermore, stability studies might be able to detect subtle differences that are not readily.....The tests and analytical procedures chosen to define drug substance or drug product specifications alone are.....Generally, therefore, real-time concurrent stability studies on the product potentially affected by..
http://www.fda.gov/cber/gdlns/ichcompbio.htm (score=89)

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.....At specific times for waiver or deferral of pediatric stud-during the drug investigation..
http://www.fda.gov/cber/ind/21cfr312.pdf (score=88)

Population Pharmacokinetics
...Because the population approach is a rapidly evolving area of drug development and.....The subjects of pharmacokinetic studies are usually healthy volunteers or highly selected.....Consequently, drug and/or metabolite(s) stability, assay sensitivity, selectivity, recovery, linearity, precision..
http://www.fda.gov/cder/guidance/1852pk.htm (score=88)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...In a comparability protocol we recommend that you include a plan for the stability studies that will.....2 The general term product as used in this guidance means drug substance, drug product, and intermediate.....plan to conduct stability studies, we recommend that you state this clearly and provide..
http://www.fda.gov/OHRMS/DOCKETS/98fr/protcmc.pdf (score=87)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...In a comparability protocol we recommend that you include a plan for the stability studies that will.....2 The general term product as used in this guidance means drug substance, drug product, and intermediate.....plan to conduct stability studies, we recommend that you state this clearly and provide..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=87)

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