SASAT (South Asian Society on Atherosclerosis & Thrombosis) proposal for regulatory guidelines for generic low-molecular weight heparins (LMWHs)

Clinical and Applied Thrombosis/Hemostasis

Volumn 15, Issue 1, 2009, Pages 8-11

  Kalodiki, Evi ^a   Leong, Wendy ^a   Fareed, Jawed ^b  

^a LOYOLA UNIVERSITY MEDICAL CENTER   (United States)

^b NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LOW MOLECULAR WEIGHT HEPARIN;

ANTICOAGULATION; DEEP VEIN THROMBOSIS; DRUG ACTIVITY; DRUG SAFETY; HEPARIN INDUCED THROMBOCYTOPENIA; HUMAN; KIDNEY DYSFUNCTION; LUNG EMBOLISM; MEDICAL SOCIETY; NONHUMAN; OSTEOPOROSIS; PRACTICE GUIDELINE; PRIORITY JOURNAL; SHORT SURVEY; THROMBOSIS PREVENTION; VENOUS THROMBOEMBOLISM;

ASIA, SOUTHEASTERN; DRUG APPROVAL; DRUGS, GENERIC; HEPARIN, LOW-MOLECULAR-WEIGHT; SOCIETIES, MEDICAL;

EID: 58449099659     PISSN: 10760296     EISSN: None     Source Type: Journal    
DOI: 10.1177/1076029608329113     Document Type: Short Survey

References (9)

1. Directive 2001/83/EC, as amended.
2. Guideline on similar biological medicinal products (CHMP/437/04/draft).
3. Guideline on clinical investigation of medicinal products for prophylaxis of high intra and postoperative venous thromboembolic risk (CPMP/EWP/707/98 Rev. 1 - draft).
4. Concept paper on similar biological medicinal products containing low-molecular weight heparins-(non) clinical issues.
5. Note for guidance on toxicokinetics: a Guidance for assessing systemic exposure in toxicological studies (CPMP/ICH/384/95).
6. Note for guidance on nonclinical locale tolerance testing of medicinal products (CPMP/SWP/2145/00).
7. Guideline on risk management systems for medicinal products for human use (EMEA/CHMP 96286/2005).
8. Note for Guidance on good clinical safety data management: definitions and standards for expedited reporting (CPMP/ICH/377/95).
9. Harenberg, J., Kakkar, A., Bergqvist, D., Barrowcliffe, T., Casu, B., Fareed, J., Holmer, E., Mismetti, P., Ofuso, F., Raake, W., Sammama, M., Schulman, S. Bio-similar low-molecular weight heparins of the Scientific Subcommittee on Anticoagulation of the International Society of Thrombosis and Haemostasis. In Press.