Scientific Positions within Office of Pharmaceutical Science
...Review and evaluate manufacturing procedures, microbiology protocols and data regarding drug.....metabolism studies, pharmacokinetic studies in hepatic and/or renal impaired patients, and pharmacokinetic studies.....Their primary function is the review of microbiological aspects of drug manufacturing to..
http://www.fda.gov/cder/OPS/positions.htm (score=100)

Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls...
...Data from drug product studies to investigate the potential effect of and the appropriateness of the.....If drug substance and drug product information is provided in an appendix, the preferred presentation is drug.....The design and extent of the compatibility studies depend on the type of drug product and..
http://www.fda.gov/cber/gdlns/drugcmc.htm (score=66)

WAIS Document Retrieval
...Such studies should normally be conducted on the drug product or drug substance containing the degradation products to be controlled.....The level of any degradation product present in a new drug product that has been adequately tested and found safe in.....If data are not available to qualify the proposed specification level of a degradation product..
http://www.fda.gov/cder/guidance/ichq3b.htm (score=65)

ICH; Draft Guidance on Q8 Pharmaceutical Development
...The knowledge gained from the studies investigating the potential effect of drug substance properties on drug product.....These studies could include, for example, the development of a dissolution or drug release.....Any overages in the manufacture of the drug product, whether they appear in the final..
http://www.fda.gov/cber/gdlns/ichq8pharm.htm (score=63)

...Chemical Substances describes some of the circumstances in which drug product studies are.....1 Components of the Drug Product 5 2.1.1 Drug Substance 5 2.1.2 Excipients 5 2.2 Drug Product 6.....The knowledge gained from the studies investigating the potential effect of drug substance..
http://www.fda.gov/cder/guidance/6672dft.doc (score=63)

6672dft.doc
...identification of those attributes that are critical to the quality of the drug product, taking.....establish an in vitro/in vivo correlation the results of those studies, and a cross.....functionality, and to perform throughout the intended drug product shelf life, should also..
http://www.fda.gov/cder/guidance/6672dft.pdf (score=62)

International Conference on Harmonisation; Draft Guidance on Q8...
...identification of those attributes that are critical to the quality of the drug product, taking.....establish an in vitro/in vivo correlation the results of those studies, and a cross.....functionality, and to perform throughout the intended drug product shelf life, should also..
http://www.fda.gov/cber/gdlns/ichq8pharm.pdf (score=62)

Q8 Pharmaceutical Development
...Chemical Substances describes some of the circumstances in which drug product studies are.....The knowledge gained from the studies investigating the potential effect of drug substance properties on drug product.....These studies could include, for example, the development of a dissolution or drug release..
http://www.fda.gov/cder/guidance/6672.dft.htm (score=61)

MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....conduct and/or complete prescribed studies on production batches of a drug after approval.....program because they can affect the ability of the product to deliver reproducible doses..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=59)

ICH: Final Guideline on Stability Testing of Biotechnological/Biological...
...the product retains its full potency, purity, biotechnological/biological products but are.....time, real-condition stability studies. Thus, should be representative of the quality of.....Food and Drug Administration, opportunity for tripartite harmonization.. ionic content..
http://www.fda.gov/cber/gdlns/ichq5c071096.pdf (score=58)

...However, it is strongly suggested that studies be conducted on the drug substance and drug product under accelerated.....Studies of the exposure of the drug substance or drug product to extreme conditions may help to reveal patterns of.....Primary data to support a requested storage period for either drug substance or drug product should be based on..
http://www.fda.gov/cber/gdlns/ichq5c071096.txt (score=58)

/a/content.18356
...Provided as a service by the Staff College, Center for Drug Evaluation and Research, Food.....medical products as drugs, biologics, associated with positive CSF findings, labeling.....what lessened if submitted reports, irre- results from studies utilizing these data..
http://www.fda.gov/medwatch/articles/med.pdf (score=57)

Submission of Abbreviated Reports and Synopses in Support of M
...During the development of a product, studies may be conducted that ultimately do not.....special populations, drug-drug interaction studies, and population pharmacokinetics and/or.....meet the requirements of Section 118 of the Food and Drug Administration Modernization Act..
http://www.fda.gov/cder/guidance/2097fnl.pdf (score=54)

Document
...Submission of the application must be Food and Drug Administration.. cited in section V.C.....health, including special populations, approved product, studies of approved .. Research Involving.....controlled clinical studies conducted to .. requirements of the Federal Food, Drug, a..
http://www.fda.gov/OHRMS/DOCKETS/98fr/053002e.pdf (score=54)

Submission of Abbreviated Reports and Synopses in Support of M
...During the development of a product, studies may be conducted that ultimately do not.....special populations, drug-drug interaction studies, and population pharmacokinetics and/or.....meet the requirements of Section 118 of the Food and Drug Administration Modernization Act..
http://www.fda.gov/cber/gdlns/abbrev.pdf (score=54)

Guidance for Industry - Submission of Abbreviated Reports and Synopses in...
...For example, clinical drug and biological product development programs often include numerous clinical studies.....During the development of a product, studies may be conducted that ultimately do not contribute to.....Clinical drug development programs vary widely in the number of studies performed and the..
http://www.fda.gov/cber/gdlns/abbrev.htm (score=54)

...One approach to facilitating drug product availability is to support clinical research to.....Although gentamicin is an approved product, studies of approved products to evaluate new.....All studies of new drug products must be conducted under the FDA's investigational new..
http://www.fda.gov/OHRMS/DOCKETS/98fr/053002e.htm (score=54)

Submission of Abbreviated Reports and Synopses in Support of Marketing...
...For example, clinical drug and biological product development programs often include numerous clinical studies.....During the development of a product, studies may be conducted that ultimately do not contribute to.....Clinical drug development programs vary widely in the number of studies performed and the..
http://www.fda.gov/cder/guidance/2097fnl.htm (score=54)

abbreviated reports
...During the development of a product, studies may be conducted that ultimately do not.....special populations, drug-drug interaction studies, and population pharmacokinetics and/or.....For example,clinical drug and biological product development programs often include..
http://www.fda.gov/cder/guidance/2097dft.pdf (score=54)

stability guidance -draft
...Information to support the stability of the drug product during the toxicologic studies and the.....this guidance to mean a batch of drug substance or drug product manufactured at the scale typically encountered.....include results from microbial challenge studies performed on the drug product at..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=41)

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