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.....an internal reservoir containing sufficient formulation for multiple doses that are..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Guidance- Content & Format CMC for Vaccine & Related Product
...and derivatives, or glycolipids, used in purification or production of the drug substance,should be described in detail, including.....A discussion of any differences in formulation, manufacturing process, or site between the.....A list should be provided of all components in the drug product, including drug substance(s)and other ingredients, with..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=91)

stability guidance -draft
...Drug substance batches used to produce site-specific drug product batches should be clearly.....the same formulation of the dosage form in the container and closure proposed for.....analytical profiles of batches of the drug substance and drug product used in the preclinical..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=89)

Substance
...individual batches of the drug substance used in animal and clinical testing, Drug Substance.....Production of a drug substance, whether by synthesis, fermentation, or isolation, usually.....by the pharmaceutical industry in the formulation of finished drug products. This.. includes any substance that is..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=79)

...A chemical constituent of a botanical raw material, drug substance, or drug product that is used for identification and/or quality.....In the case of a multi-herb substance, it is composed of the same formulation as a historical formula, with the amount of each.....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)

...When evaluating a bulk drug substance used to treat a less serious illness, FDA will generally be more.....formulation, FDA is proposing to include it on the bulk drugs list for use in this dosage.....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=70)

PTC in Manufacture and Testing of Monoclonal Antibody Products for Human Use
...A brief description of the formulation process and areas to be used for it should be provided.This description should.....entity or is produced by a novel process, and when drug development plans are unusually.....Purified Bulk Lots (Drug Substance) In addition to lot-to-lot safety testing summarized in..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=70)

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.....which are used in addition to the cells may be categorized as excipients, additional..
http://www.fda.gov/cber/gdlns/somgene.pdf (score=69)

WAIS Document Retrieval
...When evaluating a bulk drug substance used to treat a less serious illness, FDA will generally be more.....formulation, FDA is proposing to include it on the bulk drugs list for use in this dosage.....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=67)

...The areas used for final fill of drug products should follow the recommendations provided in the "Guidelines on.....A brief description of the formulation process and areas to be used for it should be.....Purified Bulk Lots (Drug Substance) In addition to lot-to-lot safety testing summarized in..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=67)

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=64)

Guidance for Industry: Developing Medical Imaging Drug and Biological...
...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.....safety and effectiveness of the drug in humans, or if the radioactive drug has a..
http://www.fda.gov/cber/gdlns/medimagesaf.pdf (score=55)

Guidance for Industry: Developing Medical Imaging Drug and Biological...
...However, if a radioactive drug is used for immediate therapeutic, diagnostic, or similar purposes.....We recommend that the formulation used to establish safety margins in nonclinical studies.....A study that investigates the potential undesirable pharmacodynamic effects of a substance..
http://www.fda.gov/cber/gdlns/medimagesaf.htm (score=3)

...However, if a radioactive drug is used for immediate therapeutic, diagnostic, or similar purposes.....Formulations used in nonclinical studies We recommend that the formulation used to.....A study that investigates the potential undesirable pharmacodynamic effects of a substance..
http://www.fda.gov/cder/guidance/5742prt1.doc (score=3)

...Other comments declared that dietary supplements are safer than most regularly-used drug.....The petitioner must demonstrate, among other things, that the use of the substance at.....The agency notes that for health claims to be used on conventional foods, an interested..
http://www.fda.gov/OHRMS/DOCKETS/98fr/010600a.txt (score=0)

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