| nr |
titel |
auteur |
tijdschrift |
jaar |
jaarg. |
afl. |
pagina('s) |
type |
| 1 |
A biosimilar industry view on the implementation of the WHO guidelines on evaluating similar biotherapeutic products
|
Schiestl, Martin
|
|
2011
|
39 |
5 |
p. 297-299
3 p.
|
artikel
|
| 2 |
Acknowledgements
|
|
|
2011
|
39 |
5 |
p. 251-
1 p.
|
artikel
|
| 3 |
Aims and Scope/Editorial Board/Publishing Details
|
|
|
2011
|
39 |
5 |
p. IFC-
1 p.
|
artikel
|
| 4 |
An Indian manufacturer’s perspective for harmonization of guidelines for similar biotherapeutic products
|
Babu, P.V. Cherish
|
|
2011
|
39 |
5 |
p. 300-303
4 p.
|
artikel
|
| 5 |
Announcement
|
|
|
2011
|
39 |
5 |
p. I-
1 p.
|
artikel
|
| 6 |
Biosimilars and non-innovator biotherapeutics in India: An overview of the current situation
|
Malhotra, Hemant
|
|
2011
|
39 |
5 |
p. 321-324
4 p.
|
artikel
|
| 7 |
Biosimilars clinical development program: Confirmatory clinical trials: A virtual/simulated case study comparing equivalence and non-inferiority approaches
|
Fletcher, Mark P.
|
|
2011
|
39 |
5 |
p. 270-277
8 p.
|
artikel
|
| 8 |
Biosimilars – Global issues, national solutions
|
Knezevic, Ivana
|
|
2011
|
39 |
5 |
p. 252-255
4 p.
|
artikel
|
| 9 |
Biotechnological products in Pan American Health Organization (PAHO): Regional efforts towards harmonization of regulation
|
Pombo, María L.
|
|
2011
|
39 |
5 |
p. 348-
1 p.
|
artikel
|
| 10 |
China’s perspective on similar biotherapeutic products
|
Liang, Chenggang
|
|
2011
|
39 |
5 |
p. 312-316
5 p.
|
artikel
|
| 11 |
Clinical programs in the development of similar biotherapeutic products: Rationale and general principles
|
Berghout, Alexander
|
|
2011
|
39 |
5 |
p. 293-296
4 p.
|
artikel
|
| 12 |
Concept of biosimilar products in Jordan
|
Haddadin, Rania Dakhlallah
|
|
2011
|
39 |
5 |
p. 333-335
3 p.
|
artikel
|
| 13 |
Contributors
|
|
|
2011
|
39 |
5 |
p. 250-
1 p.
|
artikel
|
| 14 |
Current development in regulation of similar biotherapeutic products in Brazil
|
Castanheira, Laura Gomes
|
|
2011
|
39 |
5 |
p. 308-311
4 p.
|
artikel
|
| 15 |
Current regulatory and scientific considerations for approving biosimilars in Iran
|
Hadavand, Naser
|
|
2011
|
39 |
5 |
p. 325-327
3 p.
|
artikel
|
| 16 |
Evaluation of similar biotherapeutic products (SBPs): Scientific principles and their implementation
|
Knezevic, Ivana
|
|
2011
|
39 |
5 |
p. 256-261
6 p.
|
artikel
|
| 17 |
Evaluation of similar biotherapeutic products: Scientific and regulatory challenges
|
Griffiths, Elwyn
|
|
2011
|
39 |
5 |
p. 249-
1 p.
|
artikel
|
| 18 |
Experience of reviewing the follow-on biologics including Somatropin and erythropoietin in Japan
|
Arato, Teruyo
|
|
2011
|
39 |
5 |
p. 289-292
4 p.
|
artikel
|
| 19 |
Intended use of Reference Products & WHO International Standards/Reference Reagents in the development of Similar Biological Products (Biosimilars)
|
Thorpe, Robin
|
|
2011
|
39 |
5 |
p. 262-265
4 p.
|
artikel
|
| 20 |
Quality, safety and efficacy of follow-on biologics in Japan
|
Yamaguchi, Teruhide
|
|
2011
|
39 |
5 |
p. 328-332
5 p.
|
artikel
|
| 21 |
Registration of similar biological products – Singapore’s approach
|
Poh, Jalene
|
|
2011
|
39 |
5 |
p. 343-345
3 p.
|
artikel
|
| 22 |
Regulatory guideline for biosimilar products in Korea
|
Suh, Soo Kyung
|
|
2011
|
39 |
5 |
p. 336-338
3 p.
|
artikel
|
| 23 |
Regulatory guidelines for biosimilars in Malaysia
|
Abas, Arpah
|
|
2011
|
39 |
5 |
p. 339-342
4 p.
|
artikel
|
| 24 |
Reviewing non clinical data for a granulocyte colony stimulatory factor product: Experience in Brazil
|
Castanheira, Laura Gomes
|
|
2011
|
39 |
5 |
p. 282-283
2 p.
|
artikel
|
| 25 |
Similar biological medicinal products currently licensed in the European union - Overview of non-clinical study programs
|
Heim, Hans-Karl
|
|
2011
|
39 |
5 |
p. 284-288
5 p.
|
artikel
|
| 26 |
Statistical considerations for confirmatory clinical trials for similar biotherapeutic products
|
Njue, Catherine
|
|
2011
|
39 |
5 |
p. 266-269
4 p.
|
artikel
|
| 27 |
Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010)
|
Kang, Hye-Na
|
|
2011
|
39 |
5 |
p. 304-307
4 p.
|
artikel
|
| 28 |
The first subsequent entry biologic authorized for market in Canada: The story of Omnitrope, a recombinant human growth hormone
|
Klein, Agnes V.
|
|
2011
|
39 |
5 |
p. 278-281
4 p.
|
artikel
|
| 29 |
The regulatory framework for similar biotherapeutic products in Cuba
|
Hechavarría Núñez, Yanet
|
|
2011
|
39 |
5 |
p. 317-320
4 p.
|
artikel
|
| 30 |
Towards regulation of similar biotherapeutic products: Thailand’s perspective
|
Thanaphollert, Prapassorn
|
|
2011
|
39 |
5 |
p. 346-347
2 p.
|
artikel
|
| 31 |
WHO/KFDA joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea 24–26 August, 2010
|
Wadhwa, Meenu
|
|
2011
|
39 |
5 |
p. 349-357
9 p.
|
artikel
|
Tijdschrift beschrijving