Draft reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product

Overview of comments received on Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product. (EMA/CHMP/SWP/620008/2012)

Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective

When an innovative product (innovator) is not covered anymore by intellectual property rights, cheaper equivalent medicinal products (generic products) may be marketed and used in clinical practice. The regulation of generic products is well-established, and is primarily based on standard rules for quality, therapeutic equivalence requirements (the latter in most instances proven through a bioe...

Preparation of surface modified magnetic Iron Oxide nanoparticles and study of their colloidal behavior

In this work, we report synthesis of surface modified superparamagnetic iron oxide nanoparticles (SPION) by co-precipitation method using FeSO4.7H2O and Fe2(SO4)3.5H2O as precursors and trisodium citrate dihydrate as surfactant. Surface modification of the as prepared samples was performed in pot by sol-gel precipitation method u...

Post-marketing control of Matricaria chamomilla L. and Thymus vulgaris L. products by reference and developed methods

Background: Post-market surveillance (PMS) is an integral part of ongoing safety evaluation, for natural health products. Matricaria chamomilla (chamomile) and Thymus vulgaris (thyme) are the most widely used plants in herbal medicinal products. Thymus species contain phenolic compounds such as thymol, carvacrol and terpenoids, flavonoids, and saponins. T. vulgaris is an antiseptic and antituss...

Preparation of surface modified magnetic Iron Oxide nanoparticles and study of their colloidal behavior

In this work, we report synthesis of surface modified superparamagnetic iron oxide nanoparticles (SPION) by co-precipitation method using FeSO4.7H2O and Fe2(SO4)3.5H2O as precursors and trisodium citrate dihydrate as surfactant. Surface modification of the as prepared samples was performed in pot by sol-gel precipitation method u...