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Guidance for industry : immediate release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation.
Connect to full text Available online
View online- Format:
- Book
- Government document
- Language:
- English
- Subjects (All):
- Solid dosage forms--Testing--Documentation--United States.
- Solid dosage forms.
- Drugs--Therapeutic equivalency--Documentation--United States.
- Drugs.
- United States.
- Physical Description:
- 1 electronic resource (26, 1 pages)
- Other Title:
- Immediate release solid oral dosage forms
- Scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation
- Place of Publication:
- [Rockville, Md.] : Center for Drug Evaluation and Research, [1995]
- Notes:
- "CMC 5"--Preliminary page.
- "November 1995."
- Includes bibliographical references (pages 25-26).
- OCLC:
- 586037897
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