DOPATREE
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DOPATREE
UNITED STATES GOVERNMENT ORGANIZATIONS / LISTINGS
US FOOD AND DRUG ADMINISTRATION (FDA)
DRUGS AND BIOLOGICS / RELATED / US
DRUG AND BIOLOGIC FORMULATIONS-ALL
DRUG AND BIOLOGIC FORMULATIONS / TYPES
ORAL DRUGS AND BIOLOGICS-ALL
ORAL DRUGS AND BIOLOGICS / TYPES
SOLID ORAL DOSAGES-ALL (SOD, ORAL SOLIDS, TABLETS, CAPSULES, PILLS, PHYSICAL-CHEMICAL IDENTIFIERS, DISSOLVING, FAST-DISSOLVE, DISINTEGRATION, SUPAC-MR, MODIFIED RELEASE, EXTENDED RELEASE, ER, SEMI-)
SOLID ORAL DOSAGES / LAWS AND REGULATIONS / US
Parents
SOLID ORAL DOSAGES-ALL (SOD, ORAL SOLIDS, TABLETS, CAPSULES, PILLS, PHYSICAL-CHEMICAL IDENTIFIERS, DISSOLVING, FAST-DISSOLVE, DISINTEGRATION, SUPAC-MR, MODIFIED RELEASE, EXTENDED RELEASE, ER, SEMI-)
Children
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 430.100 UNIT DOSE LABELING FOR SOLID AND LIQUID ORAL DOSAGE FORMS. JAN 31, 1984.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 400.325 CANDY "PILLS" REPRESENTATION AS DRUG. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 460.600 CONTENT UNIFORMITY TESTING OF TABLETS AND CAPSULES. OCT 02, 1987.
US FDA. DRAFT GUIDANCE. M13A BIOEQUIVALENCE FOR IMMEDIATE-RELEASE SOLID ORAL DOSAGE FORMS. JAN 2023.
US FDA. GUIDANCE. DISSOLUTION TESTING AND ACCEPTANCE CRITERIA FOR IMMEDIATE-RELEASE SOLID ORAL DOSAGE FORM DRUG PRODUCTS CONTAINING HIGH SOLUBILITY DRUG SUBSTANCES. AUG 2018.
US FDA. GUIDANCE. DISSOLUTION TESTING OF IMMEDIATE RELEASE SOLID ORAL DOSAGE FORMS. AUG 25, 1997.
US FDA. GUIDANCE. EXPIRATION DATING AND STABILITY TESTING OF SOLID ORAL DOSAGE FORM DRUGS CONTAINING IRON. JUL 09, 1997.
US FDA. GUIDANCE. EXPIRATION DATING OF UNIT-DOSE REPACKAGED SOLID ORAL DOSAGE FORM DRUG PRODUCTS. JUL 2020.
US FDA. GUIDANCE. EXTENDED RELEASE ORAL DOSAGE FORMS: DEVELOPMENT, EVALUATION, AND APPLICATION OF IN VITRO/IN VIVO CORRELATIONS. SEP 01, 1997.
US FDA. GUIDANCE. GENERAL PRINCIPLES FOR EVALUATING THE ABUSE DETERRENCE OF GENERIC SOLID ORAL OPIOID DRUG PRODUCTS. NOV 2017.
US FDA. GUIDANCE. INCORPORATION OF PHYSICAL-CHEMICAL IDENTIFIERS INTO SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR ANTICOUNTERFEITING. OCT 2011.
US FDA. GUIDANCE. ORALLY DISINTEGRATING TABLETS. DEC 2008.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. ANNEX 9(R1). TABLET FRIABILITY GENERAL CHAPTER. SEP 2017. REV. 1.
US FDA. GUIDANCE. SIZE, SHAPE, AND OTHER PHYSICAL ATTRIBUTES OF GENERIC TABLETS AND CAPSULES. OCT 2022. REV. 1.
US FDA. GUIDANCE. SUPAC : MANUFACTURING EQUIPMENT ADDENDUM. DEC 2014.
US FDA. GUIDANCE. SUPAC-IR QUESTIONS AND ANSWERS ABOUT SUPAC-IR GUIDANCE. FEB 18, 1997.
US FDA. GUIDANCE. SUPAC-IR: IMMEDIATE-RELEASE SOLID ORAL DOSAGE FORMS: SCALE-UP AND POST-APPROVAL CHANGES: CHEMISTRY, MANUFACTURING AND CONTROLS, IN VITRO DISSOLUTION TESTING, AND IN VIVO BIOEQUIVALENCE DOCUMENTATION. NOV 01, 1995.
US FDA. GUIDANCE. SUPAC-MR: MODIFIED RELEASE SOLID ORAL DOSAGE FORMS SCALE-UP AND POSTAPPROVAL CHANGES: CHEMISTRY, MANUFACTURING, AND CONTROLS. IN VITRO DISSOLUTION TESTING AND IN VIVO BIOEQUIVALENCE DOCUMENTATION.. OCT 06, 1997.
US FDA. GUIDANCE. SUPAC-SS: NONSTERILE SEMISOLID DOSAGE FORMS. SCALE-UP AND POST-APPROVAL CHANGES: CHEMISTRY, MANUFACTURING AND CONTROLS. IN VITRO RELEASE TESTING AND IN VIVO BIOEQUIVALENCE DOCUMENTATION.. MAY 01, 1997.
US FDA. GUIDANCE. TABLET SCORING : NOMENCLATURE, LABELING, AND DATA FOR EVALUATION. MAR 2013.