Stages in drug discovery and development

Discovery/Basic Research

• Synthesis and Extraction – the process of identifying new molecules with the potential to produce a desired change in a biological system

• Biological Screening and Pharmacological Testing – studies to explore the pharmacological activity and therapeutic potential of compounds

Preclinical Testing

• Toxicology and Safety Testing – tests to determine the potential risk a compound poses to humans and the environment, involve use of animals, tissue cultures or other test systems

• Pharmaceutical Dosage Formulation and Stability – the process of turning an active compound into a form and strength suitable for human use

Regulatory Review : IND

• Application to regulatory authority to use compound in human testing. In the US the compound is then called an Investigational New Drug (IND)

Phase I Clinical Trials

• Testing of a new compound in 20-80 healthy human volunteers to determine tolerance, pharmacological effects, and absorption, distribution, metabolism and excretion (ADME) patterns

Phase II Clinical Trials

• Trials in 100-300 patients with the targeted condition to determine effectiveness in treating disease or medical condition and short term risks

Phase III Clinical Trials

• Trials on 1000-5000 patients to determine clinical benefit and incidence of adverse reactions

Process Development for Manufacturing and Quality Control

• Engineering and manufacturing design activities to establish capacity to produce in large volumes and to ensure stability, uniformity and overall quality

Bioavailability Studies

• Use of healthy volunteers to show that formulation used in trials is equivalent to product to be marketed

Regulatory Review: NDA

• Application for approval to market a new drug. In the US this is called a New Drug Application (NDA)

Phase IV

• Post marketing trials to identify undetected adverse effects and long term morbidity and mortality profile

Exercise 1. Comprehension questions.

1. What is one of the fastest growing healthcare sectors?

2. What have evolved into innovative platforms?

3. What can drug delivery systems improve?

4. What can drug delivery system boost?

5. What have drug delivery technologies become an integral part of?

6. What have the advances in drug delivery technologies gone hand in hand with?

7. What capacity do new drug delivery systems have?

8. What do novel drug delivery technologies offer?

9. What are the stages in drug discovery and development?

10. What are synthesis and extraction?

11. What are biological screening and pharmacological testing?

Vocabulary exercises

Exercise 2. Find Russian equivalents to the following.

1. compliance, 2. conventional, 3. disorders, 4. emerge, 5. forefront, 6. furthermore, 7. growth, 8. immense, 9. novel, 10. patch

Exercise 3. Find English equivalents to the following.

1. общепринятый, 2. беспорядки, 3. появляться, 4. увеличивать, 5. к тому же, 6. рост, 7. огромный, 8. влияние, 9. накладка, 10. ставка

Exercise 4. Match the following words and expressions from column A with those in column B.

A B

1. disorders a. неполадки

2. enhance b. окончание (срока)

3. expiration c. увеличивать

4. immense d. выпуск

5. issue e. огромный

1.	2.	3.	4.	5.

Exercise 5. Translate the following expressions.

1. emerge - emergence

2. eventual – eventually

3. forefront – to place in the forefront

4. issue – today’s issue – an issue of blood – national issue – the issue of the day

5. patch – a patch of potatoes – a purple patch – hills patched with snow – patch pocket

Exercise 6. Translate the following sentences.

A.

1. The applications of drug delivery technologies are immense.

2. The right drug delivery system can boost a product’s market value.

3. Gene based therapies will eventually provide novel treatments for diseases such as cancer, infectious diseases and metabolic disorders.

4. The main areas of focus include oral drug delivery, injectable delivery, transdermal and transmucosal delivery, pulmonary delivery, and drug delivery based gene therapy.

5. Products incorporating innovative drug delivery systems hold the promise of rich rewards and exciting opportunities.

6. Drug delivery technologies have also become an integral part of a product’s life-cycle management – extending a drug’s exclusivity and profitability.

B.

1. Any chemically and physically homogeneous mixture of two or more substances is said to be a solution.

2. The intervention of a porous substance, called the filter, is necessary in performing the process of filtration.

3. The tablet is the most common form of medication for the administering of a drug in a dry state.

4. A great variety of shapes and sizes is available among medical tablets.

5. Ointments are semi-solid preparations for external applications of such consistency that they may be readily applied to the body or to mucous membranes.

Exercise 7. Insert the appropriate form of the verbs in brackets. Fill in the blanks “of” if necessary.

1. Drug Delivery … one …. the fastest growing healthcare sectors, with sales of drugs incorporating drug delivery systems increasing at an annual rate of 25%. (to be)

2. The drug delivery industry …. from the shadow …. the mainstream pharmaceutical industry to become an influential force. (to emerge)

3. Drug delivery systems …. along way from just simple reformulation with limited application. (to come)

4. The ointment base usually ….. the major portion …. the pharmaceutical preparation. (to constitute)

5. The tablet … the most common form … medication for the administering of a drug in a dry state. (to be)

6. The choice of method … upon the medicament and the physical properties … the constituents. (to depend)

7. Delivery technologies …. into innovative platforms that will positively impact the global pharmaceutical industry in every therapeutic category. (to evolve)

8. Novel drug delivery technologies …. new capabilities to revive the market potential for these compounds by providing new solutions to old problems. (to offer)

9. By 2013, the US drug delivery market alone will be worth $34 billion. (to be worth)

Exercise 8. Finish up the sentences using the correct words and word combinations from the right-hand column.

1. Drug delivery systems can improve…. 2. Drug delivery technologies have also become…. 3. New drug delivery systems including nasal sprays, extended-release oral formulations, topical creams, transdermal patches, and inhalational compounds have…. 4. The right drug delivery system can boost a product’s market value…. 5. Developing new and improved pharmaceuticals utilizing drug delivery technologies has allowed drug delivery companies to offer ….. 6. Drug delivery systems have come along way from ……

a. …..the capacity to expand the market for therapeutic peptides b. ……viable solutions to pharmaceutical companies’ key products which face patent expiration, thus expanding product line shelf-life and sustaining revenue for these best-sellers. c. …..a product’s medicinal value by providing pharmacological superiority over conventional products on the market. d. …..just simple reformulation with limited application. e. ……an integral part of a product’s life-cycle management – extending a drug’s exclusivity and profitability. f. ……by reducing compliance issues, such as multiple applications, side-effects and tolerability.

Exercise 9. True or False Statements.

1. Drug Delivery is one of the fastest growing healthcare sectors, with sales of drugs incorporating drug delivery systems increasing at an annual rate of 25%.

2. Agricultural industry is emerging from the shadow of the mainstream pharmaceutical industry to become an influential force.

3. Drug delivery systems have come along way from just simple reformulation with unlimited application.

4. Furthermore, the right drug delivery system can boost a product’s market value by reducing compliance issues, such as multiple applications, side-effects and tolerability.

5. Most of these compounds are either administered by injection only or are abandoned because of strong bioavailability and/or solubility.

6. By 2013, the US drug delivery market alone will be worth $14 billion.

Exercise 10. Read about drug delivery technologies