MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....An alternative approach may be used if such approach satisfies the requirements of the.....of each facility involved in the manufacturing of the drug substance and excipients should..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

GUIDE TO INSPECTIONS OF BULK PHARMACEUTICAL CHEMICALS
...Related substances are defined as those structurally related to a drug substance such as a degradation product or impurities.....a substance that is represented as a drug and, when used, becomes an active ingredient or finished dosage.....The USP also notes that the impurity profile of a drug substance is a description of the..
http://www.fda.gov/ora/inspect_ref/igs/bulk.html (score=94)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....its specification and, therefore, can be used in the manufacture of a given drug product.....Justification for an in-process test that is used in lieu of a drug substance test should..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=92)

Guidance for Industry: Human Somatic Cell Therapy and Gene Therapy
...Note that if drug substance (defined as bulk product not necessarily in final formulation)and.....Virus or DNA preparations used as preventive vaccines are not covered by this document.....abbreviate testing and IND submission for a product or product series, the sponsor should..
http://www.fda.gov/cber/gdlns/somgene.pdf (score=91)

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.....same areas used to produce the drug substance that is the subject of this application.....This section should contain information on the final drug product including all drug substances..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=90)

...When evaluating a bulk drug substance used to treat a less serious illness, FDA will generally be more.....To qualify for these statutory exemptions, a compounded drug product must satisfy several.....However, for a bulk drug substance used to treat a more serious or life-threatening disease, there may be..
http://www.fda.gov/ohrms/dockets/98fr/010799b.txt (score=89)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....its specification and, therefore, can be used in the manufacture of a given drug product.....Justification for an in-process test that is used in lieu of a drug substance test should..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=88)

WAIS Document Retrieval
...When evaluating a bulk drug substance used to treat a less serious illness, FDA will generally be more.....To qualify for these statutory exemptions, a compounded drug product must satisfy several.....However, for a bulk drug substance used to treat a more serious or life-threatening disease, there may be..
http://www.fda.gov/cder/fdama/pclist.txt (score=85)

Document
...351, 352, 353a, 355, nominated drug substances is limited, number and size of the bulk.....abstracts from reliable medical sources, substance has been used in pharmacy.. relevant.....through the new drug approval process, Academy of Compounding Pharmacists, rigorous and..
http://www.fda.gov/cder/fdama/pclist.pdf (score=83)

Substance
...individual batches of the drug substance used in animal and clinical testing, Drug Substance.....relation to the amount of crude product, whether it is filtered while hot, whether a.....Production of a drug substance, whether by synthesis, fermentation, or isolation, usually..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=81)

...A chemical constituent of a botanical raw material, drug substance, or drug product that is used for identification and/or quality.....These regulations require documentation of the drug substance, drug product, placebo, labeling, and an.....To ensure that a botanical drug product used in clinical trials is of consistently good quality, and..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=79)

stability guidance -draft
...this guidance to mean a batch of drug substance or drug product manufactured at the scale typically encountered.....and the test methods used to monitor the stability of the drug substance and preliminary.....and the test methods used to monitor the stability of the drug product packaged in the..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=76)

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 products as defined.....specificity, avidity,microbiological safety), appropriate product comparability testing.....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=74)

Guidance for Industry: Developing Medical Imaging Drug and Biological...
...demonstrating whether the proposed drug product is safe for use under the conditions prescribed.....However, if a radioactive drug is used for immediate therapeutic, diagnostic, or similar purposes.....pharmacodynamic effects of a substance on physiologic functions in relation to exposure..
http://www.fda.gov/cber/gdlns/medimagesaf.pdf (score=71)

CBER Regulatory SOPP 8401.4 Review Responsibilities for the CMC Section of...
...Conjugates or modified drug substances derived from another drug substance or intermediate through chemical or enzymatic.....Review should evaluate the production and maintenance of water systems used in manufacturing and rinsing of product contact.....A detailed description of the specification and acceptance criteria for the native drug or in vitro..
http://www.fda.gov/cber/regsopp/84014.htm (score=5)

Content and Format of INDs for Phase 1 Studies of Drugs, Inclu
...proposed for use in a clinical study to the drug product used in the animal..toxicology studies that.....of the IND to demonstrate that the new drug substance and drug product..are within acceptable.....clinical use and the drug product used in the animal toxicology..trials that formed the basis for the..
http://www.fda.gov/cder/guidance/clin2.pdf (score=2)

IND content and format for Phase 1 studies
...As clinical development of a drug product proceeds,sponsors should discuss the manufacturing.....being proposed for use in a clinical study to the drug product used in..the animal toxicology studies.....drug substance and drug product are within acceptable chemical and..physical limits for the..
http://www.fda.gov/cder/guidance/phase1.pdf (score=2)

Guidance for Industry Botanical Drug Products
...These regulations require documentation of the drug substance, drug product, placebo, labeling, and an.....To ensure that a botanical drug product used in clinical trials is of consistently good quality, and.....The quality control tests performed on each batch of the drug substance, the analytical procedures used, and the available test..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=2)

...Systemic exposure patterns reflect both release of the drug substance from the drug product and a series of possible.....If the drug product is to be used predominantly in the elderly, we also recommend that the sponsor attempt to.....Orally Administered Drugs Intended for Local Action Documentation of product quality BA for NDAs where the drug substance produces..
http://www.fda.gov/cder/guidance/5356fnl.doc (score=2)

Human Subject Protection; Foreign Clinical Studies Not Conducted Under an...
...safe use of the proposed drug product, studies provided they are well-designed, provides.....decisionmaking on product applications of nonIND foreign clinical trials of drug support.....A description of the drug substance .. requirement is unnecessary or cannot be the drug for use..
http://www.fda.gov/cber/rules/forclinstud.pdf (score=2)

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