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Australia remains one of the important markets of the continent with major contributions to the healthcare and pharmaceutical industry. As a part of major revamping of the pharmaceutical sector and to align with the western world, the regulations governing medications and medical devices underwent significant change under the government directive in October 2014. The regulatory…

Clinical trial success depends on the selection of a clinical trial site.  A "right site" for clinical trials is defined as a location that possesses the necessary resources, including infrastructure, experienced personnel, and access to an appropriate patient population, allowing for the successful and ethical execution of clinical research studies. Selecting the right site for clinical trials is imperative to…

Study site for a clinical study is one of the most crucial factors for a successful research program. A suitable potential site for clinical trials is the study site that could be a medical facility, hospital or research institution that engages in clinical research program. Any such facilities must possess suitable infrastructure and resources. This includes a medical…

Clinical trial data is the final outcome of any clinical research programs. The Clinical research programs are primarily conducted to collect important health related information about the study participants and the influence of the intervention provided to the participants on a specific health related parameter. The clinical data arising from a clinical trial is thus very diverse and its collection…

OTC pharmaceuticals are those that can be purchased over-the-counter (OTC) without a prescription or seeking medical attention. Although OTC medicines are freely available in the market and can be easily purchased, it is essential that for proper use, people should adhere to the instructions on the "Drug Facts Label" on OTC medications. OTC medications can be used to treat…

Healthcare is a public welfare endeavor and all the governments across the countries strive for better healthcare facilities and policies for the citizens. One of the important attributes is to improve the market access for various treatments and therapies at affordable costs. As the drug development is a long process once available, its accessibility for…

Cryogenics products contain cryogenic liquids that turn into gases under ambient temperatures. The word cryo- means “cold” and –genic means “producing”. Although cryogenic science is under the faculty of physics, it has wide applications in the field of medicine, materials science and electronics. Due to the changes in the state of matter with temperature change, the operations for management of…

Drug development is primarily driven by three factors: quality, efficacy, and safety. The essential quality, nonclinical safety, and efficacy standards that are established by the assessment of the new drug's clinical efficacy and safety for its intended therapeutic indications in accordance with the ICH guidelines were covered in the previous few blogs. We'll concentrate on the…

To identify potential safety concerns such as unpleasant adverse effects of the medicines, ICH provides comprehensive guidelines that can be considered for therapeutic safety monitoring within the community. These safety guidelines are applicable during the non-clinical development of the new medicines. Safety assessment during the clinical trials and for the marketed medicines is considered under…

The mainstay of drug development is based on 3 parameters such as quality, efficacy and safety. In the last few blogs we discussed the important quality and nonclinical safety aspects as per the ICH guidelines. Today we will focus on the efficacy guidelines that are determined by the evaluation of the clinical efficacy and safety…

The People’s Republic of China is a huge pharmaceutical market and big pharma companies have been trying to get into the Chinese market for the past few years. Recognizing the need for new drugs for the people of China with an opportunity to develop an indigenous industry, the Chinese government over the years has made…

A global initiative called the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together powerful regulatory agencies from Europe, Japan, USA, and pharmaceutical companies to create guidelines and discuss the scientific and technical facets of developing pharmaceutical products and registering them. The goal of the ICH is to advance public…