Investigative New Drug Testing : Testing And Development Of New Drugs

When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the

There are several types of medication, each has a purpose and function needed for their administration via the different routes.

-Delays in clinical trial approvals by the government: India is one of the preferred destination for clinical tests due to diversity existent in India. Clinical tests are a mandatory and a very important part of the innovation curve in Pharmaceutical industry. This has led to the success of pharmaceuticals. However, the government approvals required to conduct these tests and the regulations are stringent, making this a critical factor.

1. Cost: The drug development is a lengthy and an expensive process. It will aid in the predevelopment process to identify future demand and to identify if it is a worthwhile venture. The future of a company could depend on the success or failure of a new drug in the market.

The U.S. Food and Drug Administration (FDA) is responsible for protecting and promoting public health through regulating pharmaceutical drugs, biologics and medical devices in the context of granting approvals for marketing authorization, surveillance of the clinical trial study of the drug, and post-marketing surveillance of the medical product. Pharmaceutical companies seek FDA approval for a new drug to be marketed which entails a long process. This process starts with submitting an application known as an investigational new drug application (IND) to start clinical trials to enroll a group of patients believed to benefit from the investigational product, and to approve that the drug is safe and effective.

an NDA/BLA to FDA as they are ready, rather than the standard requirement to submit

The healthcare rofessional explain the process of obtaining the investigational product to the patient is of prime importance especially when the patient has exhausted all the available medications and therapies. During the clinical trials, Andrea or any patient cannot obtain the drug until the drug becomes approved or the patient is eligible for the study according to the protocol. Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The investigational new drug (IND) is the means through which the sponsor technically obtains this exemption from the FDA. The IND is not an application for marketing approval. Rather, it is a

A drug development time may take on average over 15 years and expenditure R & D total costs of about $880 million. The length for and FDA application is at least 100,000 pages, which details the potential drug’s usage, production, formula and labeling.

A number of documents and approvals need to be prepared before commencing the human clinical trials. The core document is Investigator’s Brochure (IB), which includes all relevant scientific information of the drug obtained from

The early process for submitting under the 505(b)2 mechanism includes identifying the compound, determining which pathway to use, setting up a pre-Investigational New Drug (IND) meeting, and meeting with the Food and Drug Administration to determine the appropriate course.

The amount that companies are spending is also a big factor that contributes to the issue, most start out companies are seen getting ideas and research from universities and other companies, but these companies typically do not utilize them the way they should. Again this is because laws put in place by the industry prevent them from doing so. ”Price controls that reduce prices too low reduce output and capacity, lower the quality of the services that are provided, and diminish the incentives for innovation, including ongoing R&D”. The industry has no excuse however, because the manipulation of drug prices has almost backfired on them. People have become aware that the pricing is ridiculously high, and the industry is quite getting everything they need. The industry has created most of the problems they are trying to solve today and continue to seemingly make worse the problems on purpose. Pharmaceutical companies are struggling to appease the public because of the laws the industry have implemented, smaller companies usually fail because of the needs for profit, and other needs to keep companies alive.

It generally 12 years for a potential new drug to go from the lab to garnering approval for use. The clinical development of a drug can be time consuming and expensive which accounts approximately 45 to 75 percent of the $1.2 billion average cost of bringing a new therapy to market. There are 4 phases of clinical development that is done are pre-clinical trials.

The discovery of a new drug without involving human subjects is called as non clinical studies. Goals of non-clinical testing of Biologics are: characterization of probable undesirable drug effects, identifying toxicities on organs, identifying convertibility of toxicity , characterization of pharmacokinetic report, characterization of favorable pharmacodynamic effects -proof of standard, guideline for safe application in human clinical studied, determination of a safe and practical starting dose, and offer monitoring strategy for the clinical study, offer adequate clinical data to conclude

Phase III is the first large-scale trial of human testing. This phase can only begin if the new drug shows to be effective in the phase II. Phase III seeks to further determine the effectiveness of the drug. This is done by testing the drug on different populations, meaning that testing will be done on more people, testing will be done on different drug doses, and the drug will be tested on patients who are also taking other drugs. If Phases I through III show the investigational new drug to be safe and effective, then the pharmaceutical company will file a New Drug Application (NDA). The NDA includes both the results of the first three trial phases and data on how the drug is manufactured (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001;

This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.