China’s pharmaceutical market is constantly growing and is the second-largest pharmaceutical industry in the world, after the United States. It is estimated to reach $161.8 billion by 2023, with an average growth rate of 5% in the coming years, taking a 30% share of the global market. The acceleration of new drug access, changing regulatory […]

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Most errors and technical failures in clinical trials arise due to the improper selection of clinical trial designs. The clinical trial design selection will also have a strong impact on the cost and time associated with clinical trials. The expected outcomes shall be thoughtfully addressed while designing a clinical trial and the selection of clinical […]

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Myanmar’s pharmaceutical market size was $456 million in 2017 with a percapita pharma expenditure of $8.5 and expected to reach $656 million in 2022. Myanmar’s economy is growing continuously, and the pharmaceutical industry is predicted to quickly grow into a $1.12 billion industry in the future. In Myanmar, both non-communicable diseases and communicable diseases are […]

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Oncology trials are considered to be more complicated than trials in any other therapeutic area. The research in oncology differs in the trial design, type of trial, the role of a comparator, treatment outcomes, adverse events reporting, interpreting the results, etc. The growth in the global oncology market is moving at a rapid pace. In […]

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Do you know, according to clinicaltrials.gov, a total of 354,130 clinical trials were registered worldwide with 71,256 ongoing clinical trials as recorded on Oct-2020? The number of clinical trials is increasing year by year from 56.16k in 2017 to 60.69k in 2018. In the USA, more than 2.3+ million people participate in approximately 80,000+ clinical […]

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Clinical trials in rare diseases are more challenging than clinical trials in more frequent diseases for many factors such as the trial design, the number of patient populations available for recruitment, require regulatory support, etc. Applying a perfect clinical development strategy may help in overcoming these challenges and accelerate the drug development process in Orphan […]

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The US FDA recommends efficient clinical trial design strategies to expedite the development of oncology drugs and biologics. FDA also provides guidance and advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first-in-human (FIH) trials. In contrast to traditional trial designs, where a single […]

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Drug development is a lengthy, complex, and costly process, entrenched with a high degree of uncertainty that a drug will actually succeed and reach the market successfully. Drug development is the process of bringing a new pharmaceutical drug or a medical device or a treatment procedure to the market. Many developers often lack a clear […]

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Drug development is a process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. The drug development process starts from drug discovery to getting market approval and post-marketing studies. This entire process of medical device/drug development takes years and completely depends on […]

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This article is a sequence of United States: Drug Approval Regulatory Process Part-I which describes the Investigational New Drug (IND) approval process, New Drug Approval (NDA), and Generic drug approval process. In this article, we will discuss the marketing approval process of Biologics, Biosimilars, Orphan drugs, and various approval pathways. Which is the regulatory authority for biologics […]

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