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Pharmaceutical Development

Pharmaceutical-Industry-Research And Development | Rondaxe

Pharmaceutical Industry Research And Development

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Table of Contents What are the Latest Trends in Pharmaceutical R&D and New Drug Approvals? What Factors Affect Research and Development Spending? Trends in R&D Spending and New Drug Development R&D Spending Each year, the pharmaceutical industry in the United States develops several new medications with substantial medical benefits. Unfortunately, many of these medications are expensive, leading to rising healthcare costs for the private and public sectors. Policymakers have looked at ways to reduce the cost of medications and government drug expenditure, and such restrictions would very likely reduce the pharmaceutical industry’s incentive to do new research. In one study, the Congressional Budget Office (CBO) analyzes changes in pharmaceutical research and development (R&D) spending as well as the introduction of new medications. Additionally, the CBO examines the following factors that affect how much money pharmaceutical companies spend on research and development: Anticipated worldwide profits from a new medication Cost of developing a new drug Government…

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Lifecycle of a Product

Lifecycle of a Product: The Development of a New Drug

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Table of Contents What is the drug development life cycle? New therapeutic product development Preclinical/non-clinical studies Clinical trials What is the drug development life cycle? Developing a new drug (e.g., a new medicine or biologic) is a lengthy, complicated, and costly process that usually takes 10 to 12 years (or more) from product discovery to commercialization. This lifespan typically consists of the following stages: Discovery and research: Identify targeted therapy for illness or condition diagnosis, cure, mitigation, treatment, or prevention. Development: This comprises non-clinical research, clinical investigations, and the creation of chemistry, manufacturing, and controls (CMC) to support clinical trials (e.g., IND, IDE, CTA, IDE) and license applications (e.g., NDA, NDS, MAA). Regulatory review and approval: Data submission for regulatory assessment shows the product’s safety, effectiveness, and quality for the intended indication. Commercialization and marketing: Ongoing regulatory compliance is achieved by filing safety reports and other necessary documents (e.g., product renewal). New therapeutic product development…

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Drug Development

Drug Development – The Drug Discovery, Clinical Trial, and Post-Marketing Surveillance Process

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Table of Contents Pre-Clinical Testing Clinical Trials Human clinical trials are often conducted in phases. There are many phases involved in the creation of a drug. The procedure may need a significant amount of money and effort. Large pharmaceutical firms often have several medication candidates in development at the same time. Only a handful will make it through regulatory clearance and be marketed to the general public. This is why new drugs are so expensive. The expense is to fund this time-consuming and expensive medication development process. The drug development process comprises the following steps: Drug Discovery Pre-clinical testing Clinical trials Post-market surveillance Drug Discovery The process of screening and selecting novel medication candidates is known as drug discovery. Initially, tens of thousands of possible small compounds, natural products, or extracts are tested for desired therapeutic effects. Candidates for protease inhibitors, for example, should bind the protein protease with specific affinity, selectivity, efficacy, and metabolic…

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