Considerations for clinical pharmacology studies for biologics in emerging markets

Author:

Damle Bharat1,White Robert2,Wang Huifen Faye3

Affiliation:

1. Pfizer Inc.; New York NY USA

2. Pfizer Inc.; Collegeville PA USA

3. Pfizer Inc.; Groton CT USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference23 articles.

1. http://www.imshealth.com/deployedfiles/imshealth/Global/Content/Home Page Content/High-Growth Markets/Biologics_in_emergingmarkets.pdf

2. http://www.who.int/medicines/areas/quality_safety/regulation_legislation/certification/modelcertificate/en/

3. http://www.who.int/biologicals/biotherapeutics/rDNA_DB_final_19_Nov_2013.pdf?ua=1

4. The opportunities and challenges Involved in registration of similar biotherapeutic products in emerging countries;Navaneethaselvan;Int J Res Pharm Sci,2013

5. Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America;Ibarra-Cabrera;Biotechnol Adv,2013

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