Drug Development Stages
Pharmaceutical Development
October 25, 2022

What Are the Drug Development Stages?

Table of Contents Development and Discovery Pre-Clinical Testing Clinical Research FDA Review Thousands of medications are on the market, and new ones are being developed continuously. With so many medicines already on the market, getting one on the market may seem simpler. Developing new drugs, on the other hand, is a big job. This rigorous procedure ensures that drugs are effective and safe enough to be available to many people. But what precisely must be done to create new drugs? The drug development process can be divided into 4 parts. These phases contain all that must be done to bring new medications to market, from early research through FDA approval. The 4 stages of drug development are summarized here: Development and Discovery The discovery process is the initial stage in medication development. New illness therapies may be discovered when new insights and technology become accessible. This can start with hundreds of distinct chemicals that will be whittled down over time.…
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Drug Formulations and Conducting Clinical
Pharmaceutical Development
October 18, 2022

Developing Drug Formulations and Conducting Clinical Trials

Table of Contents What Is Drug Formulation? Why Is Drug Formulation Development Important? What Should Be Considered While Developing a Formulation? How Many Drug Dose Types Are There? What Are Early-Phase Formulation Challenges? Why Should Biotechs Outsource Drug Formulation? Biotech companies making new drugs to be tested in first-in-human (FIH) clinical trials face a big problem with how to make the drugs. Formulation development is important in the early stages of drug development, and for how well a promising investigational medicinal product will do on the market in the future. What Is Drug Formulation? Drug formulation, also called “pharmaceutical” formulation, combines different substances with the drug's active pharmaceutical ingredient (API) to make a drug product that can be given to patients safely. Why Is Drug Formulation Development Important? Formulation development is very important because it involves ensuring a drug is prepared and taken in a safe and good way for the patient.  In 2018, a survey was done to determine…
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Biotech Companies on Drug Formulation Development
Pharmaceutical Development
October 4, 2022

A Quick Guide for Biotech Companies on Drug Formulation Development and Clinical Trials

Table of Contents What is Drug Formulation? What is the Importance of Drug Formulation Development? How Should Formulation Development Begin? What are the Exact Dose Types of Drugs Available for Purchase? Why are Later Stage Clinical Trials Important When Starting a Drug Development Program? Pharmaceutical formulation is a significant obstacle for biotech businesses creating novel medications for first-in-human (FIH) clinical trials. Formulation development is crucial in the early phases of drug development and for the eventual commercial viability of a promising investigational medical product. This article gives a practical introduction to drug formulation development features —within the context of early-phase clinical trials— to aid biotechnology businesses in this crucial phase of the drug development process. What is Drug Formulation? Drug formulation, also known as a pharmaceutical formulation, is the process by which a number of components are mixed with a pharmacological's active pharmaceutical ingredient (API) to generate a drug product that may be administered to patients safely. What is the…
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Uncategorised
June 4, 2020

Will Big Pharma Sabotage its’ Own Re-Shoring?

The need to reshore American products has been recognized on a federal level for many decades, with legislation such as the original Buy American Act, dated to 1933. The urgency has grown in recent years, with the burgeoning dependence of the United States on foreign medicines and medical equipment now constituting a huge strategic burden.  The issue has recently come to forefront because of  renewed distrust in supply chain stability thanks to Covid-19, however, and current legislation is upping the ante by including Big Pharma among the list of key players that need to be reformed. The imperative to return American products home is primarily being addressed through legislation offering incentives aimed at making American businesses more competitive, imposing tariffs on foreign goods and offering tax benefits for American manufacturers.  Although 28% of registered worldwide pharmaceutical API manufacturing sites are located within the US, according to government statistics when we consider the sourcing of raw materials, various estimates suggest that…
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