DDD UNIT1

___________________ is a significant approach to the overall advancement of the healthcare community.

Drug Discovery and Development (DDD)

It is (broadnarrow) and complex.

broad

From the pre-discovery phase up to the Post Marketing

Surveillance involves a lot of procedures and protocols

that must be followed throughout the process and may

even take more than ___ years.

10

Medical and pharmaceutical research provides a basis for

the development of (new/old) therapeutic approaches to human

and animal disease.

new

• This process of drug discovery research can be basic

(seeking an understanding of biological phenomena that

are _______)

• or applied (using principles that are _______ to produce a

desired new product or effect).

• unknown

• known

drug discovery

is the process by which drugs are discovered or designed

drug development

is the process of bringing a new drug to the market once a lead compound has been identified through drug discovery

The major objective of research in the

pharmaceutical industry is:

to produce safe drugs that prevent, cure, or

ameliorate disease.

major objectives:

1. Understand the (atomic/ molecular) basis of biological mechanisms in health and disease.

2. Develop (old/new) biological testing procedures relevant to human and veterinary medicine.

3. Develop a quantitative understanding of the interaction of drugs with key biological systems, leading to the more rational design of drugs.

4. Understand the absorption, transport, and mode of action of drugs. Develop drugs of low toxicity, reproducible delivery, and high specificity for a given pathological state or target organ.

• molecular basis

• old

Researchers work to:

A. validate these targets,

B. discover the right molecule (potential drug) to interact with the target chosen,

C. test the new compound in the lab and clinic for safety and efficacy and

D. gain approval and get the new drug into the hands of doctors and patients.

drug development process

discovery and development > preclinical research > clinical research > fda review > post-market safety monitoring

drug discovery and development process

new chemical entity > preclinical studies > IND > preclinical and clinical trials > NDA > postmarketing

ETHNOPHARMACOLOGY

the interdisciplinary scientific exploration of biologically active agents traditionally employed or observed by man.

_______ are the sources of pharmacologically active agents and recent progress in discovering NCEs has resulted in new drugs that are useful in treating cancer, viral, bacterial and immunosuppressive diseases (Butler, 2005).

Natural products

Discovering ____________(NCEs) from plant

sources has been the first mind stuck for the plant

chemists in both academics and industry. Compounds of

natural origin still play a major role in development of new

drugs.

new chemical entities (NCEs)

______, world’s largest selling anticancer drug is the

synthetic derivative of Taxol, isolated from Taxus

brevifolia (Newman & Cragg, 2007).

Paclitaxel