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The Global Biosimilars Market is estimated to reach US$240 billion by 2030, with the Indian market at US$35 billion. The considerable increase in reference products, with the USFDA adding 90 molecules and India approving 70 biosimilars, promises to usher in further growth. The Biopharma industry seems keen on investing in the biosimilar market with a focus on improving healthcare and health care costs for diseases of interest like COVID-19, cancer, immunologic diseases, and diabetes. This is evident in the projected growth of the oncology biosimilar market at 17 per cent CAGR, and the growing

The drug business has various strange qualities that make it very different from individuals' thought process of as industry. Its additionally an industry packed with logical inconsistencies; for instance, notwithstanding the undisputed reality that for more than a century the business has made a major contribution to human prosperity and the decrease of chronic sickness and suffering, it is still routinely recognized bygeneral society in assessment reviews as one of the most un-confided in ventures, frequently being contrasted horribly with the atomic business. It is without a doubt perhaps

It’s been nearly two years since the outbreak of COVID-19 began and we’re still in the midst of enormous disruptions to the world’s economies, businesses, education, and people’s lives. The pharmaceutical industry has been particularly disrupted. Previously, pharma companies suffered from a bad reputation. But following the emergence of the pandemic, they were thrown into the spotlight, suddenly having an important voice on the health of the world. Leaders in the pharma space were on the front cover of every newspaper and magazine not because of scandal, but because of the lifesaving treatmen

Similar to the restrictions provided under HGRAC Regulation, the Biosecurity Law confirms that foreign persons are generally prohibited from collecting or preserving HGR in China or providing HGR abroad. Foreign persons will have limited rights to acquire and/or use China’s HGR through scientific research activities conducted in collaboration with Chinese entities but only with the prior approval of China’s Ministry of Science and Technology (MOST). The only exception to the requirement of obtaining approval is for clinical trials conducted through international cooperation at clinical trial

In the ever-evolving realm of pharmaceutical research and development (R&D), the powerful wave of digitalization is restructuring conventional methodologies and paving the way for a novel era of ingenuity and streamlined processes. Termed digital transformation, this profound shift entails the strategic infusion of cutting-edge information technologies into established drug discovery and development procedures. Leading this revolution are technologies like big data analytics, artificial intelligence (AI), blockchain, and telemedicine. Digital transformation signifies a potential revolution in

Nanomaterials have been one of the most exciting scientific and technical innovations of the past few decades. Due to their very high surface to volume ratios, they exhibit properties that can differ dramatically from those for the same material in bulk. This, and their ability to be designed and synthesized with multiple surface functionalities, has seen them used for a myriad of bespoke applications in industry and medicine.

Their medical applications span delivery systems for drugs, proteins and DNA/RNA to diagnostics, targeted cancer treatments, to theranostics. They have been used ver

Pharmaceutical companies are faced with the challenge of effectively managing and analyzing large volumes of data, which come in various formats, in order to extract meaningful and actionable insights. This is crucial for efficient drug development that balances cost and effectiveness. The use of cutting-edge technologies can help uncover the mechanisms of diseases, optimize clinical trials, and improve production efficiency and accuracy. By utilizing data analytics and automation, pharmaceutical companies can optimize their manufacturing processes and ensure timely and reliable delivery of d

Clinical trials are an essential part of the development of new medical treatments and procedures, and they help to ensure that new interventions are safe and effective for patients above all. Because of that, it is really important that all steps in that process were done with special attention to patient safety above all, but also to the accuracy of data that is often still collected manually, which slows down the entire process, and sometimes even compromises it, which result with the fact that clinical trials are exposed to frequent audits precisely for this reason.

Although clinical t

Clinical research technology platforms have also emerged, providing participant-facing apps and websites where you can build in or interface with some or all the previously mentioned solutions, as well as expanding to other research-related activities such as virtual training, electronic informed consent form (eICF), participant recruitment, engagement, visit reminders and concierges, etc. Implementing these platforms, the individual participant is given an even more active role in their own research journey, as they are responsible to enter their own subjective data directly into the designa

To bring this into reality, pharmaceutical PV organisations need to move into a “digitalised future” where technology plays a key role in PV processes. This includes automating and streamlining the information streams to reduce complexity, from case processing to reporting. Once automated, companies need to begin to look to artificial intelligence to add further value from their data.

By applying artificial intelligence (AI) and data science approaches, organisations can turn the overabundance of data from being a challenge to solve, into an opportunity. A well-designed, automated, AI-powe

Artificial Intelligence (AI) and machine learning-based technologies have the potential to transform healthcare because they offer new and important insights derived from the vast amount of data generated during the delivery of healthcare every day. The capacity of AI to learn from real-world feedback and improve its performance makes this technology uniquely suited as Software as a Medical Device (SaMD) and is responsible for it being a rapidly expanding area of research and development. Clinical pharmacy practice may undergo major change due to the implementation of this technology. The cha

Functional service has been ranked high among the buzz words of the clinical research industry. Both sponsor organisations and service providers are equally excited about the opportunities this model offers and the potentially win-win situation it provides to them. Sponsor organisations typically send individual protocol-related service RFPs (request for proposals) to CROs and follow-up with contract negotiations. Sponsors have realised the benefits of reduced oversight and contract management a complete functional service outsourcing model offers saving valuable time and resources

Pharmaceutical development is the identification and evaluation of cycles needs to change over a functioning drug fixing into a medication item reasonable for its expected reason. In the beginning phases of medication advancement, this will be for limited scope assembling of item to be utilized in clinical preliminaries. In the event that the preliminaries are fruitful, the cycle should be refreshed and improved to make it reasonable for make on a business scale. The drug improvement process starts by estimating the properties of the medication substance, and recognizing the basic quality cre

The drug business has various strange qualities that make it very different from individuals' thought process of as industry. Its additionally an industry packed with logical inconsistencies; for instance, notwithstanding the undisputed reality that for more than a century the business has made a major contribution to human prosperity and the decrease of chronic sickness and suffering, it is still routinely recognized bygeneral society in assessment reviews as one of the most un-confided in ventures, frequently being contrasted horribly with the atomic business. It is without a doubt perhaps

In a clinical trial, actors admit specific interventions according to the exploration plan or protocol created by the investigators. These interventions may be medical products, similar as medicines or bias; procedures; or changes to actors' geste , similar as diet [1]. Clinical trials may compare a new medical approach to a standard bone that's formerly available, to a placebo that contains no active constituents, or to no intervention. Some clinical trials compare interventions that are formerly available to each other. When a new product or approach is being studied, it isn't generally kno

The earliest example of in vivo expression of exogenous mRNA is by direct intramuscular injection in mice without the aid of a delivery vehicle. The current state of the art for therapeutic nucleic acid delivery is lipid nanoparticles (LNP), which are composed of cholesterol, a helper lipid, a PEGylated lipid and an ionizable amine-containing lipid. The liver is the primary organ of LNP accumulation following intravenous administration and is also observed to varying degrees following intramuscular and subcutaneous routes. Delivery of nucleic acid to hepatocytes by LNP has therapeutic potenti

This Biopharmaceutics introduces fundamental concepts, methods, and advances in the areas of dissolution, absorption, and permeability and their key applications in dosage form performance. Case studies are used to discuss the applications of biopharmaceutic strategies in the development of successful drugs, with a specific focus on the applications of biopharmaceutic strategies in the development of successful drugs. The book presents an integrated view in linking pharmaceutic to the biological consequences of drug products and leverages those for decision making in drug development. The Bio

Certainly, we are all alike, but we are all unique. And the notion that medication would be used in a way that overlooks those disparities is as absurd as walking to a sneaker store to pick up any old pair of sneakers without first verifying the size. Personalized medicine provides an excellent chance to transform a "one size fits all" strategy to diagnostics, pharmacological therapy, and treatment into a personalised strategy. Nanotechnology advancements have enabled the development of nanomaterials devices for the enhanced diagnosis and tailored treatment of a various range of complicated d

Metals and alloys are the first generation bio-inert biomaterials. These materials possess excellent mechanical strength, low elastic modulus and good corrosion resistance. Titanium (Ti) and its alloys are one of the commonly used metallic biomaterials for orthopedic applications e.g. bone plates, screws, dental implants and prostheses. Both bulk and surface properties of a biomaterial decide its fate. The initial contact between the surface and biological fluids regulates biointerfacial interactions like wetting, protein adsorption and cell adhesion. Once an implant (biomaterial) comes into

The successful introduction of commercial lipidic formulations of cyclosporine as Sandimmune in 1981, followed by its reformulation as Neoral, has raised interest of the lipid-based drug delivery technology over the past two decades.1 With a greater understanding of the various functions lipids may have in boosting oral bioavailability, interest in Lipid Based Drug Delivery (LBDD) has grown over the past ten years. Additionally, the potential for successful lipid-based formulations has been significantly increased by the emergence of novel excipients with acceptable regulatory and safety prof