2013年4月1日 · For this guidance only, the new document that is a combination of these two guidances will be referred to as the SUPAC addendum. We update guidances periodically.
Approval Change (SUPAC) Expert Working Group of the Chemistry Manufacturing Controls Coordinating Committee (CMC CC) of the Center for Drug Evaluation and Research at the …
SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale …
2020年5月5日 · This guidance provides recommendations to sponsors of new drug applications (NDA's), abbreviated new drug applications (ANDA's), and abbreviated antibiotic applications …
Federal Register :: Guidance for Industry on Scale-Up Post …
2014年12月2日 · The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) guidance for industry entitled "SUPAC: …
SUPAC-MR：固体口服缓控释制剂放大生产和批准后变更：体外释 …
本指导原则的建议适用于新药申请（NDA）、仿制药申请（ANDA）和抗生素仿制药申请（AADA）中的固体口服调释制剂的批准后变更，其包括：（1）成份或组成的变更；（2）生 …
FDA Guidance for Industry: SUPAC: Manufacturing Equipment Addendum ...
This draft guidance combines and supersedes the following scale-up and post-approval changes (SUPAC) guidances for industry: (1) SUPAC-IR/MR: Immediate Release and Modified …
SUPAC Guideline - Pharmanotes
2022年1月11日 · SUPAC guidance provides recommendations to sponsors of new drug applications (NDA’s), abbreviated new drug applications (ANDA’s), and abbreviated antibiotic …
The SUPAC guidance documents define (1) levels of change; (2) recommended chemistry, manufacturing, and controls tests for each level of change; (3) in vitro dissolution tests and/or …
SUPAC-IR指导原则：速释口服固体制剂放大生产和批准后变更(Site …
本指导原则规定了以下内容：1）变更的类别；2）针对每一类变更建议进行的药物化学、药品生产以及生产和质量控制（CMC）研究内容；3）针对每一类变更建议进行的体外溶出试验和/或体 …
Scale Up, Post Approval Changes (SUPAC guidelines)
SUPAC is scale-up and the post-approval changes (changes that are made after approval) like in the formulation of the drug, batch size, process, equipment, site of manufacturing. SUPAC …