FDA Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances

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Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances[附网盘链接]是FDA于过去发布的FDA标准，适用于美国。

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Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance is developed to provide manufacturers with recommendations for submission of new drug applications (NDAs), investigational new drug applications (INDs), or abbreviated new drug applications (ANDAs), as appropriate, for orally administered immediate-release (IR) 2

drug products that contain highly soluble drug substances. The guidance is intended to describe when a standard release test and criteria may be used in lieu of extensive method development and acceptance criteria-setting exercises. This guidance finalizes the guidance for industry on Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms 3

Containing Biopharmaceutics Classification System Class 1 and 3 Drugs (August 2015). The revised title of this guidance better reflects its focus on the solubility of the drug substance in the drug product. Therefore, a direct reference to biopharmaceutics classification system (BCS) class 1 and class 3 is not necessary because permeability requirements are not within the focus of this guidance. The recommendations in this guidance clarify the recommendations in the guidance for industry on Dissolution Testing of Immediate Release Solid Oral Dosage Forms 4

(August 1997) for high solubility drug substances in IR drug products that meet the conditions described in section III in this guidance. For drug substances that do not meet the conditions in this guidance, sponsors/applicants should follow the recommendations provided in the August 1997 guidance mentioned above. 1

This guidance has been prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. 2

Drug substance is an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient. 21 CFR 314.3(b). 3

We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 4

Drug product is a finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients. 21 CFR 314.3(b). 1

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