SCOPUS 정보 검색 플랫폼

Biologicals

Volumn 39, Issue 5, 2011, Pages 339-342

Regulatory guidelines for biosimilars in Malaysia

(1) Abas, Arpah a

a MINISTRY OF HEALTH (Malaysia)

Author keywords

Biopharmaceuticals; Biosimilars; Comparability; Regulation; Safety

Indexed keywords

BIOLOGICAL PRODUCT; GENERIC DRUG;

ARTICLE; DRUG EFFICACY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HEALTH CARE AVAILABILITY; HEALTH CARE POLICY; MALAYSIA; PATIENT SAFETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; TREATMENT OUTCOME;

DRUG INDUSTRY; GUIDELINES AS TOPIC; HUMANS; LEGISLATION, DRUG; MALAYSIA; PHARMACEUTICAL PREPARATIONS;

EID: 80053560240 PISSN: 10451056 EISSN: 10958320 Source Type: Journal
DOI: 10.1016/j.biologicals.2011.06.009 Document Type: Article

Times cited : (13)

References (10)

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- (2008) National Pharmaceutical Control Bureau, guidance document and guidelines for registration of biosimilars in Malaysia

2
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- Kresse, G.B.¹

5
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- Biosimilar therapeutics - what do we need to consider?
- Schellekens H. Biosimilar therapeutics - what do we need to consider?. Biosimilar therapeutics - what do we need to consider? 2009, (Suppl. 1).
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- Schellekens, H.¹

6
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- Schellekens H. Biosimilar epoetins erythropoietins, erythropoietic factors and erythropoiesis 2009.
- (2009) Biosimilar epoetins erythropoietins, erythropoietic factors and erythropoiesis
- Schellekens, H.¹

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- The challenge of biosimilars
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- Scientific and regulatory considerations on the immunogenicity of biologics
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- Biosimilar insulins: are they really 'similar'?
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.