Contents:

Drug development: the journey of a medicine from lab to shelf

Development and Evaluation of Drugs: From Laboratory through Licensure to Market - CRC Press Book

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Drug development: the journey of a medicine from lab to shelf

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Drug Development Process

From Laboratory through Licensure to Market. Development and Evaluation of Drugs: Add to Wish List. Toggle navigation Additional Book Information. Description Table of Contents Reviews.

Features Updates and expands on the information provided in the previous edition Discusses hot topics such as genome structures, rational drug design, good manufacturing practices, and more Covers bioavailability and bioequivalence and their importance to drug manufacturers Provides detailed regulatory information for critical phases of drug development pre-licensure, and post-marketing Phase IV studies Summary Since its initial publication in , Development and Evaluation of Drugs from Laboratory through Licensure to Market has been used as a textbook and reference for scientists in biomedical research, industry, and regulatory agencies.

Updated and expanded, this second edition examines recent advances in scientific and regulatory approaches as well as changes in the way in which drugs are discovered, developed, and evaluated. The information provided outlines critical steps beginning from drug discovery in the laboratory to licensure and approval for market.

Since its initial publication in , Development and Evaluation of Drugs from Laboratory through Licensure to Market has been used as a textbook and. Clinical phases of drug development include phase I in healthy the initial drug approval through post-marketing monitoring of adverse events. as the ' selection of compounds by evaluating their desirability in a computational model' [7]. can be tested and validated in the basic research laboratory' [10].

Biomedical research is an intrinsically changing and evolving field. A more direct strategy for drug discovery has gradually replaced random screening of natural products. In doing this the drug company needs to generate sufficient safety and efficacy data to demonstrate an overall risk-benefit for the medicine to allow a submission to be made for a licensing application to the regulatory authority.

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The process of drug development and marketing authorisation is similar across the world. For those drugs that make it to through phase 3, a submission for marketing authorisations is made to the national regulatory authority in most countries. However, in Europe, drug companies usually now opt to make a central application to the European Medicines Agency EMA in order to obtain marketing authorisation for the whole of Europe to avoid having to make multiple applications to individual countries.

The submission contains preclinical and clinical information obtained during testing, including information about the chemical makeup and manufacturing process, pharmacology and toxicity of the compound, human pharmacokinetics, results of the clinical trials, and proposed labelling. If a licence is granted, that is not the end of the process. NICE makes its decisions based on the cost and efficacy of a treatment to determine whether the cost-benefit it offers to the NHS is affordable.

Clinical trials may also continue. Regulatory authorities may insist on phase 4 trials for post-marketing safety surveillance pharmacovigilance or they may be undertaken by the company to enable them to target distinct markets. For example, to enable the drug to be used in patients with complex medical problems or pregnant women who are unlikely to have been involved in earlier trials, and to ensure that they do not interact with other drugs. Pharmaceutical companies will patent any molecule that shows promise early in the development process.

Patenting prevents other companies copying it for 20 years and covers many aspects of the intellectual property of a drug, including its manufacture, formulation and, in some cases, its use. The purpose of a patent is to enable the pharmaceutical company that developed it to recoup their development costs and to make a profit to cover the development costs of drugs that failed during the testing process, as well as to invest in the development of future innovative drugs.

By the time a drug has undergone the required testing and been licensed, half the patent period will usually have expired. Once a patent on a drug has expired generic versions of the drug can be manufactured and marketed.

For some drugs the period of patent protection can be extended for up to a further five-and-a-half years, so long as this does not take the time in which the drug is under patent protection beyond 15 years after the date it received regulatory approval. As drugs and their development have become more complex and expensive, so have the demands for information from the regulatory agencies.

In response, communication channels have opened up between drug companies and regulators well ahead of submissions to help ensure that companies are compiling all the relevant data required for a successful submission. The MHRA has set up a dedicated innovation office to provide advice and support to companies.

Development and Evaluation of Drugs: From Laboratory through Licensure to Market - CRC Press Book

Its main focus is to aid new drug developers and companies developing unique products such as gene and cell therapy, nanomedicines, or treatments involving new delivery systems or produced through novel manufacturing processes. Meanwhile NICE offers a fee-based consultancy service to developers of medicines to help them ensure that they generate the evidence they will need to support a NICE evaluation. NICE recommends that any advice is sought after the first human trials to aid planning of the more extensive trial programme.

For every 25, compounds that start in the laboratory, 25 are tested in humans, 5 make it to market and just one recoups what was invested. The high cost of current drug development coupled with the trend towards complex medicines and use of genomic markers to predict drug response personalised medicines may mean that, in the future, we see a more flexible drug development process and regulatory framework. For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

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An illustrated history of some of the most popular branded medicines. Includes colourful historical adverts and details of the medicine's formula and intended purpose. A practical reference source on alternative and complementary therapies. Enables healthcare professionals to give knowledge-based advice.

We provide complimentary e-inspection copies of primary textbooks to instructors considering our books for course adoption. Once a potential target has been identified, researchers will then search for a molecule or compound that acts on this target. In doing this the drug company needs to generate sufficient safety and efficacy data to demonstrate an overall risk-benefit for the medicine to allow a submission to be made for a licensing application to the regulatory authority. Reviews "In this age of rapid changes it has become almost impossible to write a book which is up to date with the most recent changes. Nevertheless, the book succeeds in giving a broad and solid account of the subject and gives a reader without a strong background in the area a good introduction into the field in a very concise and well-structured way. Latest views Is it time for community pharmacy to let go of dispensing?

Written for new pharmaceutical scientists, this book provides a background in paediatric pharmacy and a comprehensive introduction to children's medication. This established textbook covers every aspect of drug properties from the design of dosage forms to their delivery by all routes to sites of action in the body.

2nd Edition

Introduction to Renal Therapeutics covers all aspects of drug use in renal failure. Shows the role of the pharmacist in patient care for chronic kidney disease. Pharmaceutical Journal is not responsible for the content of external internet sites. Want to keep up with the latest news, comment and CPD articles in pharmacy and science?

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Development and Evaluation of Drugs: From Laboratory through Licensure to Market.
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