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The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for the companies to develop a single drug which can be simultaneously submitted in all the countries for approval. The regulatory strategy for product development is essentially to be established before commencement of developmental work in order to avoid major surprises after submission of the application. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution, and promotion of it. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development.

Isoxazole derivatives R 0240Synthesis and Biological Evaluation of 3-(Phthalimidomethyl)-4-(5-substituted isoxazoline and pyrazoline) Substituted Benzanilides. -A variety of phthalimidomethyl derivatives of isoxazoline (IX) (20 examples) and pyrazoline (X) is synthesized and evaluated for antibacterial and antifungal, anthelmintic and hypoglycemic activities. -(SAHU*, S. K.; AZAM, M. A.; BANERJEE, M.; CHOUDHURY, P.; SUTRADHAR, S.; PANDA, P. K.; MISRO, P. K.; J. Indian Chem. Soc. 84 (2007) 10, 1011-1015; Univ. Dep. Pharm. Sci., Utkal Univ., Bhubaneswar 751 004, India; Eng.) -H. Toeppel 33-137

The current study was designed to prepare and characterize insulin incorporated nanoparticles by complex coacervation process followed by antidiabetic study of orally administered insulin incorporated nanoparticles in diabetic rats. The nanoparticles were characterized for particle size, loading and entrapment efficiency as well as in vitro release of incorporated insulin. The prepared nanoparticles were found to have an average particle size of 551.67 nm ±45.5. The highest entrapment efficiency and loading capacity values were found to be of 52.48±1.98 and 47.01±1.21, respectively. Oral administration of 10 IU/Kg of insulin loaded nanoparticles to diabetic rats showed a maximum blood glucose change of 53.46 ± 2.19 at 5-hours time period. The results obtained indicate the potential of prepared nanoparticulate system as a carrier for oral delivery of insulin.

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