1. Pharmacovigilance obligations of the pharmaceutical companies in India;Arora;Indian Journal of Pharmacology,2008
2. Overview of FDA and drug development;Babiarz,2008
3. When risks cannot be seen: Regulating uncertainty in emerging technologies;Bonnín Roca;Research Policy,2017
4. CDSCO, I. (2016). Guideline on similar biologics: Regulatory Requirements for Marketing Authorization in India (pp. 1–53). New Delhi: DBT.
5. An overview of scientific and regulatory issues for the immunogenicity of biological products;Chamberlain;Developments in Biologicals,2003