TABLE OF CONTENTS

Title page-   –         –         –         –         –         –         –         –         i

Certification-          –         –         –         –         –         –         –         ii

Dedication-  –         –         –         –         –         –         –         –         iii

Acknowledgements-        –         –         –         –         –         –         iv

Table of Contents- –         –         –         –         –         –         –         v-vii

CHAPTER ONE

1.0     Introduction-         –         –         –         –         –         –         –         1-2

1.1     Definition of drugs-         –         –         –         –         –         –         2-6

CHAPTER TWO

2.0     Pharmacodynamics-        –         –         –         –         –         –         7

2.1     Pharmacokinetics- –         –         –         –         –         –         –         7-9

2.2     Pre- Clinical trial-  –         –         –         –         –         –         –         9-13

2.3     Choice of Animal Species-        –         –         –         –         –         13-16

2.4     Challenges in drug clinical and Pre-clinical studies-          –         16-17

CHAPTER THREE

3.0     Clinical Trial-        –         –         –         –         –         –         –         18-19

3.1     Important of Clinical Trial-        –         –         –         –         –         19

3.2     Safety Efficacy and Benefit-Risk Balance-    –         –         –         19-21

3.3     Regulation and Classification of Clinical Trails-     –         –         21-23

3.3.1  Phase I-       –         –         –         –         –         –         –         –         23-24

3.3.2  Phase II-      –         –         –         –         –         –         –         –         24-25

3.3.3  Phase III-     –         –         –         –         –         –         –         –         26-27

3.3.4  Phase IV-     –         –         –         –         –         –         –         –         27-28

3.4     The shep Althat and Accomplish Trials-        –         –         –         28-29

3.5     Post Marketing Surveillance-     –         –         –         –         –         30-31

CHAPTER FOUR

4.0     Summary and Conclusion-        –         –         –         –         –         32

4.1     Summary-    –         –         –         –         –         –         –         –         33

4.2     Conclusion- –         –         –         –         –         –         –         –

References

CHAPTER ONE

1.0     Introduction

Drug discovery according to Steven, et al. (2010), is still a lengthy, expensive and inefficient process with low rate of new therapeutic discovery. Discovering and bringing one drug to the public, typically costs a pharmaceutical or biotechnology company a budget range of $800 million to more than $1 billion and takes about an average of 10 – 15yrs, according to Pharmaceutical Product Development Inc (2012), a pharmaceutical research laboratory. This is supported by a similar study by Hughes et al,(2011) in which they maintained that a range of 12-15ys is required for a new drug product to successfully reach the market for clinical application.

Only preclinical studies can last for 1 – 5yrs. In addition to the cost implication and rigors of the development process, the efficiency or success rate is a great challenge. Only five in five thousand or 10% of the drugs that begin pre-clinical testing ever make it to human testing. Only one of these five is ever approved for human usage (Hughes et al, 2011).

The journey of finding a new drug for an identified disease process involves high thorough-put screening (HTS) where large number of chemicals is tested for ability to influence the target and achieve desired effect (Fox et al. 2006) This screening also helps to determine the selectivity of the chosen compound to the target. The more selective a molecule is to the target the better. This implies that it interacts with only the target and less with other related targets. A successful identification of an active compound or intended new drug sets the stage for pre-clinical trials.

1.1     Definition of Drugs

A drug is any chemical substance that causes a change in an organism’s physiology or psychology when consumed. (Drug, 2007). Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via inhalation, injection, smoking, ingestion, absorption via a patch on the skin, suppository, or dissolution under the tongue.

In pharmacology, a drug is a chemical substance, typically of known structure, which when administered to a living organism produces a biological effect. (Dale, 2011). A pharmaceutical drug, also a called a medication or medicine, is a chemical substance used to treat cure prevent, or diagnose a disease or to promote wellbeing. Traditionally drugs were obtained through extraction from medicinal plants but more recently also by organic synthesis (Linder, 2015). Pharmaceutical drugs may be used for a limited duration or a regular basis for chronic disorders.

Pharmaceutical drugs are often classified into drug classes groups or related drugs that have similar chemical structures, the same mechanism of action (binding to the same biological target), a related mode action, and that are used to treat the same disease. The Anatomical Therapeutic classification system (ATC) the most widely used drug classification system, assigns drugs a unique ATC code which is an alphanumeric code that assigns it to specific drug classes within the ATC system. Another major classification system. this claasifies drugs according to their solubility and permeability or absorption properties.

Psychoactive drugs are chemical substance that affect the function of the central nervous system altering perception, mood or consciousness. These drugs are antipsychotics, and hallucinogens. These psychoactive drugs have been proven useful in treating wide range of medical conditions including mental disorders around the world. The most widely used drugs in the world include caffeine nicotine and alcohol (Croca, 2003) which are also considered recreational drug since they are used for pressure rather than medicinal purposes. All drugs can have potential side effects. Abuse of several psychoactive drugs can cause addition and/or physical dependence. Excessive use of stimulants can promote stimulant psychosis. Many recreational drugs are illicit and international treaties such as the single convention on Narcotic Drugs exist for the purpose of their prohibition.

Development of new drugs is perceived as a very complex process, which can be described from many different points of view; science and business story behind a new drug launch do not necessary match. Brisk scientific discovery can end up in clinical study failure or even withdrawal after launch-over 90% drug leads do not make it to the market.

Therefore, general view of the contemporary pharmaceutical industry is despite of its some spectacular success, that of contain dissatisfaction globally, more is spent on drug discovery and development every year and less is delivered, in terms of radical innovation (Sepanjnia, 2012) which remains in sharp contrast to incredible progress achieved in basic science research and phenomenal involvement of technical potential. Spanning from new information technology to sophisticated roboties. Leaving aside over whelming economical R&D problems of big pharma industry with knowledge management and generating much needed innovation. We should like to discuss this part of drug research and development, which our readers are likely to come across personally as project managers, researchers or reviewers and experts. Following European integration, local scientists finally stand a chance to design and submit ambitious research projects in advanced medicinal chemistry. Prospectively realized within international cooperation. It is obvious that such development puts considerable load of responsibility on the entire environment of researchers within life sciences. In particular, chemists, pharmacists and biochemists should strive for more effective communication with drug discovery and development (DDD) area which requires some specific knowledge. We intend to recapitulate essentials of DDD process as practiced under current legal requirements. With some focus on quality assurance system and safety. In particular, an evolution of a drug candidat will be explained interms of knowledge accumulation and technical documentation filling. In order to simplify this complex task we will be concerned only with so called small molecule (basically synthetics, roughly below 1000 daltons) as opposed to biological of either natural or biotechnological origin.