Maintaining a stringent regulatory oversight of financial interests and disclosures is pivotal in clinical research ethical standards. The public well-being is always at stake when a new product is in… read more →
Abstract The application of globalized clinical trials represents a vast range of genetic variability among the human subjects within the inclusion criteria, naïve population and cost reductions in clinical trials.… read more →
The next “Big Thing” for pharmaceutical companies competing generic products for its blockbuster brand products is the ability to circumvent the issue through novelty or improved products. Evidently, the presence… read more →
Abstract Economic evaluation process in the medicinal product development is an essential and integrated element in the process continuum of the medicinal product’s performance evaluations. Ideally, economic evaluation processes would… read more →
Abstract Confidence intervals are one of the statistical tools for conducting hypothesis testing. Hypothesis testing is a common rule in research for testing the validity of the unknown population parameter.… read more →
Medicinal products’ clinical studies facilitate the provision of health care services for a specified medical needs. In other words, medicinal products and health care services are goods within the concepts… read more →
Abstract Health economics is one of the essential needs in establishing the basis for a better healthcare services and medicinal product development. The concept of health economics also deals with… read more →
Abstract The Regulation and approval process of medical devices are different from regulation and approval process of medicinal products. For instance, in the US, medical devices are regulated by the… read more →
Abstract Pharmaceutical products are not limited to therapeutic drugs and biologics. These pharmaceutical products are regulated by different branches of medicinal product’s regulatory agency. In the US, the center for… read more →
The establishment of medicinal regulatory agency’s intent is in facilitating and protecting public health interest by ensuring the safety and efficacy evaluation of medicinal products (biologics, devices, drugs) and other… read more →
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