Back to Results
First PageMeta Content
Biology / Low molecular weight heparin / Fondaparinux / Enoxaparin sodium / Factor X / Thrombosis / Anticoagulant / Platelet factor 4 / Antithrombin / Heparins / Blood / Medicine


Guidance for Industry Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs DRAFT GUIDANCE
Add to Reading List

Open Document

File Size: 135,31 KB

Share Result on Facebook

City

Balbant / Rockville / /

Country

United States / /

/

Facility

LMWH-PF4 complex / /

/

IndustryTerm

chemical approaches / polysaccharide chain / chemical reagents / manufacturing changes / manufacturing conditions / active pharmaceutical ingredient / reference product / iterative chemical / abbreviated new drug applications / overall chemical composition / reference products / guidance Web page / modified drug product / Chemical structures / manufacturing process / /

MedicalCondition

thrombocytopenia / blood clots / MS / thrombosis / Heparin-induced Thrombocytopenia / /

MusicAlbum

Rapid / /

Organization

U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / Division of Dockets Management / office of Pharmaceutical Science / U.S. Securities and Exchange Commission / office of Communications Division of Drug Information / /

Person

Ion-Pair Chromatography / Daniela Verthelyi / Gallagher / Peter Safir / Douglas Throckmorton / /

/

Position

Deputy Director / Major / /

Product

Lovenox / Heparin Sodium / /

ProvinceOrState

S.K. / Maryland / /

PublishedMedium

Biochemical Journal / Analytical Chemistry / Nature Biotechnology / /

Technology

laser / electrophoresis / antibodies / Biotechnology / API / spectroscopy / Cloning / gel electrophoresis / pdf / /

URL

http /

SocialTag