Generic Drugs
Resources
Drug Discovery and
Development
The process of drug discovery and development follows usually the following steps:
discovery, development, and marketing support. Enormous costs, over $150 million,
are involved in the development of a successful medication. The development
process lasts more than 10 years.
Drug Discovery
New molecules are usually found by synthesis of potentially new medications or
chemical modification of existing compounds; screening of natural products or other
molecules; rational design; biotechnology. Screening tests using a variety of biologic
methods are performed to determine the drug candidate compound.

Drug Development
This period includes preclinical testing of the candidate compounds, development
and analysis of the dosage form, clinical studies, and submission of marketing
approval documents.

Preclinical testing (Animal pharmacology studies)
The preclinical safety testing (done on large number of animals) consists of acute
toxicity (single-dose effect), subacute and chronic toxicity (multiple doses effect),
embryotoxicity and teratogenicity, carcinogenicity, mutagenicity.

Pharmacology Resources

Clinical studies
The human studies are conducted in accordance with the approved guidelines. The
approval for marketing of the new product is regulated in the US by the Food and
Drug Administration (FDA).

In phase 1 dose-effect studies are performed to a small number of healthy
volunteers (25-50) to determine if humans show same responses to the medication.
The study is performed by clinical pharmacologists in research centers.

In phase 2, the medication is tested in larger group of patients (50-200), to determine
its efficacy. These studies are done in special clinical centers.

In phase 3, the product is studied in large number of patients to determine its efficacy
and safety. Double-blind approach is usually used. This phase is organised in
conditions most closely approaching the indications for use.

When phase 3 concludes, New Drug Application (NDA)  for marketing approval could
be submitted to the FDA. The application contains all the reports of the preclinical
and clinical studies. The process of approval by the FDA may last more than 3 years.

Marketing Support
This period includes post-marketing surveillance studies (phase 4 clinical trials),
and marketing promotion. New clinical indications are studied, and new formulations
developed in order to extend the patent protection.
Glossary
Brand Name
The brand name is the name under which a new pharmaceutical is developed and
marketed. This name is patented by the originator company, which has developed
the medication. The company receives exclusive rights for marketing of the product
with this name.

Drug
Defined by FDA and US law as any substance intended for use in the diagnosis,
cure, relief, treatment or prevention of diseases.

Drug Safety
All drugs have side effects. Safety is tested in the preclinical and clinical stages. A
product is considered more safe when the benefits of its use strongly overweight the
risks.

Generic Drugs (Generics)
Generics are considered identical, or bioequivalent to the brand-name drugs. They
contain the same active substance as the original product and have the same
quality, efficacy and safety. They are marketed after patent expiry of the brand.

Marketing Approval
The drugs are evaluated by the authorities and approved before they may be
marketed. A licence is issued by the drug agency for approval of the product.

Patents
New drugs are developed under patent protection. The patent protects the company
investments (including research, development,
marketing etc), and prohibits other companies from making, using or selling the
product. Brand-name drugs are usually given patent protection for more than 20
years.

Pharmacokinetic studies
Pharmacokinetics studies the processes of absorption, distribution, metabolism,
and elimination of the medication in the organism.
FDA Center for Drug
Evaluation and Research
Profound information on generic
drugs: definition, Q&A, news,
approvals, therapeutic
equivalence etc.

DrugResearcher
News on drug discovery and
development

FDA Consumer Information:
Questions and Answers
Frequently asked questions about
generic drugs

FDA Ensures
Equivalence of Generics
FDA approval of generic drugs,
requirements for brand-name and
generic drugs, myths and facts,
what is bioequivalence.
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