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Drug Discovery and Development
The process of drug discovery and development follows usually
three main steps: discovery, development, and postmarketing
activities. Discovery and development of medications are very long
and expensive processes. Enormous costs, over $150 million, are
involved in the development of a successful medication. Only about
5 of 4,000 drugs studied preclinically are studied in people, and only
about 1 out of 5 drugs that enter clinical testing is approved. The
process to bring a new product to the market lasts more than 10
years.
The process of drug discovery and development follows usually
three main steps: discovery, development, and postmarketing
activities. Discovery and development of medications are very long
and expensive processes. Enormous costs, over $150 million, are
involved in the development of a successful medication. Only about
5 of 4,000 drugs studied preclinically are studied in people, and only
about 1 out of 5 drugs that enter clinical testing is approved. The
process to bring a new product to the market lasts more than 10
years.
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Drug Discovery
Generics/Brands
Drug
Information
Health
Information
Top Generic
Drugs
Buy Generic
Drugs
About
Links
Drug Discovery
New drug candidates are usually found using following approaches:
synthesis of a potential new molecule or chemical modification of
existing compounds; screening for biological activity of natural
products or other molecules; rational design; biotechnology.
However, many medications are now designed by targeting specific
disorders. New compounds are created, that may specifically
prevent or correct the disease-evoked abnormalities.
Screening tests using a variety of biologic assays are performed to
determine the drug candidate compound.
New drug candidates are usually found using following approaches:
synthesis of a potential new molecule or chemical modification of
existing compounds; screening for biological activity of natural
products or other molecules; rational design; biotechnology.
However, many medications are now designed by targeting specific
disorders. New compounds are created, that may specifically
prevent or correct the disease-evoked abnormalities.
Screening tests using a variety of biologic assays are performed to
determine the drug candidate compound.
Drug Definition
A drug is defined by US law as any substance intended for use in
the diagnosis, cure, relief, treatment or prevention of diseases.
A drug is defined by US law as any substance intended for use in
the diagnosis, cure, relief, treatment or prevention of diseases.
Drug Names
When a pharmaceutical company starts investigation of a new
compound, they use for the screening tests its chemical name or a
company code. Generic Name (INN, International Non-proprietary
Name) is an international scientific name used to identify the active
compound. The brand name (trade name) is the name under which
a new pharmaceutical is developed and marketed. This name is
patented by the originator company and it indicates that the product
is an exclusive property of this company. Brand-name drugs are
usually given patent protection for about 20 years. When the patent
expires, other companies can introduce its generic version. Generic
drugs are generally known by their generic dame (INN).
When a pharmaceutical company starts investigation of a new
compound, they use for the screening tests its chemical name or a
company code. Generic Name (INN, International Non-proprietary
Name) is an international scientific name used to identify the active
compound. The brand name (trade name) is the name under which
a new pharmaceutical is developed and marketed. This name is
patented by the originator company and it indicates that the product
is an exclusive property of this company. Brand-name drugs are
usually given patent protection for about 20 years. When the patent
expires, other companies can introduce its generic version. Generic
drugs are generally known by their generic dame (INN).
Stages of Drug Development
Drug development phase includes preclinical testing of the
candidate compounds, analytical and pharmaceutical work, clinical
studies, and preparation of marketing approval documents. The
approval for marketing of new products is regulated in the US by the
Food and Drug Administration (FDA).
Preclinical testing
Preclinical pharmacological testing includes experiments to prove
the efficacy in animals, as well as animal pharmacokinetics. 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.
Investigational New Drug Application (IND)
The results from the preclinical testing are submitted to FDA. A team
of FDA-CDER experts reviews the new drug investigational
application and approves the new molecule for testing in humans.
Clinical studies
The human studies should be conducted in accordance with the
approved guidelines.
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 drug. Furthermore, pharmacokinetic studies are
usually done to study its absorption, metabolism, and excretion.
Most frequent side effects are also registered. The study is
performed by clinical pharmacologists in research centers.
In Phase 2, the drug is tested in larger group of patients (50-200), to
determine its effectiveness in people with certain disease or
condition. Safety is also monitored, and the short-term side effects
are registered. Controlled studies are done versus placebo or a
different medication. These studies are done in special clinical
centers.
In Phase 3, the drug is studied in large number of patients to
determine its effectiveness and safety. Different doses are applied,
interactions are additionally studied. Double-blind approach is
usually used. This phase is organized in conditions most closely
approaching the indications for use.
New Drug Application (NDA)
When Phase 3 concludes, NDA for marketing approval could be
submitted to the FDA. The application contains all the reports of the
preclinical and clinical studies, pharmaceutical documentation
(dosage forms), analytical documentation (incl. stability), as well as
information how the drug is manufactured (according to the Good
Manufacturing Practice standards). The process of marketing
approval (marketing authorisation) may last several years.
Drug development phase includes preclinical testing of the
candidate compounds, analytical and pharmaceutical work, clinical
studies, and preparation of marketing approval documents. The
approval for marketing of new products is regulated in the US by the
Food and Drug Administration (FDA).
Preclinical testing
Preclinical pharmacological testing includes experiments to prove
the efficacy in animals, as well as animal pharmacokinetics. 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.
Investigational New Drug Application (IND)
The results from the preclinical testing are submitted to FDA. A team
of FDA-CDER experts reviews the new drug investigational
application and approves the new molecule for testing in humans.
Clinical studies
The human studies should be conducted in accordance with the
approved guidelines.
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 drug. Furthermore, pharmacokinetic studies are
usually done to study its absorption, metabolism, and excretion.
Most frequent side effects are also registered. The study is
performed by clinical pharmacologists in research centers.
In Phase 2, the drug is tested in larger group of patients (50-200), to
determine its effectiveness in people with certain disease or
condition. Safety is also monitored, and the short-term side effects
are registered. Controlled studies are done versus placebo or a
different medication. These studies are done in special clinical
centers.
In Phase 3, the drug is studied in large number of patients to
determine its effectiveness and safety. Different doses are applied,
interactions are additionally studied. Double-blind approach is
usually used. This phase is organized in conditions most closely
approaching the indications for use.
New Drug Application (NDA)
When Phase 3 concludes, NDA for marketing approval could be
submitted to the FDA. The application contains all the reports of the
preclinical and clinical studies, pharmaceutical documentation
(dosage forms), analytical documentation (incl. stability), as well as
information how the drug is manufactured (according to the Good
Manufacturing Practice standards). The process of marketing
approval (marketing authorisation) may last several years.
Postmarketing Activities
This period includes post-marketing surveillance studies (Phase 4
clinical trials), and marketing promotion. After the approval of the
medication, the manufacturer monitors the use of the drug and
reports to the FDA for any additional side effects after long-term use.
The aim of the post-marketing surveillance studies is to provide
additional data on efficacy, and to detect more side effects.
Important side effects might occur once in every 10,000 doses, and
could be detected only when a large number of people use the drug.
In this period new clinical indications are also persued, and new
formulations developed in order to extend the patent protection.
This period includes post-marketing surveillance studies (Phase 4
clinical trials), and marketing promotion. After the approval of the
medication, the manufacturer monitors the use of the drug and
reports to the FDA for any additional side effects after long-term use.
The aim of the post-marketing surveillance studies is to provide
additional data on efficacy, and to detect more side effects.
Important side effects might occur once in every 10,000 doses, and
could be detected only when a large number of people use the drug.
In this period new clinical indications are also persued, and new
formulations developed in order to extend the patent protection.
|
Glossary of Terms
Brand Name (Trade name)
The brand name is the name under which a new innovator medication is
developed and marketed. This name is patented by the originator
pharmaceutical company, which has developed the medication. The
company receives exclusive rights for marketing of the product with this
name. The trade name indicates that the drug is an exclusive property of the
company that has invented the medication.
Chemical Name
The name which describes the atomic or molecular structure of the active
substance.
Drug
Defined by FDA and US law as any substance intended for use in the
diagnosis, cure, relief, treatment or prevention of diseases. The perfect drug
should: be highly selective for its target system; not affect other systems; have
minimum side effects; be very potent and effective; be effective when taken
orally.
Drug Safety
Drug safety is tested in the preclinical and clinical stages of the drug
development. A drug is considered more safe when the benefits of its use
strongly overweight the risks.
Generic Drugs (Generic medicines, Generics)
Generic drugs are considered identical, or bioequivalent to the brand-name
originals. They contain the same active substance included in the same
pharmaceutical form as the original product and have the same quality,
efficacy and safety. They are marketed after patent expiry of the brand-name
drugs.
Generic Name (INN, International Non-proprietary Name)
This is the scientific name used to identify a specific molecule. Generic
medicines are generally known by their INN rather than under a trade mark
name.
Good Manufacturing Practice (GMP)
Good Manufacturing Practice ensures that pharmaceutical products are
manufactured after specific standards of quality.
Marketing Authorisation (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
for the market based on a determination that a pharmaceutical product
meets the requirements of quality, safety and efficacy for human use. The
agency in the US responsible for marketing approval of new products is Food
and Drug Administration (FDA).
Patents
New drugs are developed under patent protection. The patent gives the
originator pharmaceutical company the exclusive rights to exploit its
invention for a given period of time. The patent protects the company
investments (including research, development, marketing etc), and prohibits
other companies from making, using or selling the drug. Brand-name drugs
are usually given patent protection for more than 20 years.
Pharmacokinetics
Pharmacokinetics studies the processes of absorption, distribution,
metabolism, and elimination of the drugs in the organism.
Brand Name (Trade name)
The brand name is the name under which a new innovator medication is
developed and marketed. This name is patented by the originator
pharmaceutical company, which has developed the medication. The
company receives exclusive rights for marketing of the product with this
name. The trade name indicates that the drug is an exclusive property of the
company that has invented the medication.
Chemical Name
The name which describes the atomic or molecular structure of the active
substance.
Drug
Defined by FDA and US law as any substance intended for use in the
diagnosis, cure, relief, treatment or prevention of diseases. The perfect drug
should: be highly selective for its target system; not affect other systems; have
minimum side effects; be very potent and effective; be effective when taken
orally.
Drug Safety
Drug safety is tested in the preclinical and clinical stages of the drug
development. A drug is considered more safe when the benefits of its use
strongly overweight the risks.
Generic Drugs (Generic medicines, Generics)
Generic drugs are considered identical, or bioequivalent to the brand-name
originals. They contain the same active substance included in the same
pharmaceutical form as the original product and have the same quality,
efficacy and safety. They are marketed after patent expiry of the brand-name
drugs.
Generic Name (INN, International Non-proprietary Name)
This is the scientific name used to identify a specific molecule. Generic
medicines are generally known by their INN rather than under a trade mark
name.
Good Manufacturing Practice (GMP)
Good Manufacturing Practice ensures that pharmaceutical products are
manufactured after specific standards of quality.
Marketing Authorisation (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
for the market based on a determination that a pharmaceutical product
meets the requirements of quality, safety and efficacy for human use. The
agency in the US responsible for marketing approval of new products is Food
and Drug Administration (FDA).
Patents
New drugs are developed under patent protection. The patent gives the
originator pharmaceutical company the exclusive rights to exploit its
invention for a given period of time. The patent protects the company
investments (including research, development, marketing etc), and prohibits
other companies from making, using or selling the drug. Brand-name drugs
are usually given patent protection for more than 20 years.
Pharmacokinetics
Pharmacokinetics studies the processes of absorption, distribution,
metabolism, and elimination of the drugs in the organism.
Top Generic Drugs, Copyright 2004-2009
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information database providing
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Drugs.com
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RxList
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name.
Drug InfoNet
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pharmaceutical manufacturers.
RxMed
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information for physicians and
patients.
MedicineNet
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patient-oriented information on
over 2500 common medications.
HealthSquare
Information on prescription
medications, supplied by the PDR
Family Guide to Prescription
Drugs.
SafeMedication
Provides consumer-oriented
searcheable drug database.
WebMD
The WebMD Directory provides
patient-oriented information on
prescription drugs and
over-the-counter medications.
Best consumer-oriented
information database providing
leaflets on thousands of
prescription and non-prescription
medications.
Drugs.com
Resource for medical
professionals and consumers,
providing reliable information on
over 24,000 pharmaceuticals.
RxList
The best medications index.
Search for drug monographs is
possible by using generic or brand
name.
Drug InfoNet
Information on medications for
healthcare professionals and
consumers provided by the
pharmaceutical manufacturers.
RxMed
Comprehensive Web resource
providing drug and disease
information for physicians and
patients.
MedicineNet
Offers relevant and reliable
patient-oriented information on
over 2500 common medications.
HealthSquare
Information on prescription
medications, supplied by the PDR
Family Guide to Prescription
Drugs.
SafeMedication
Provides consumer-oriented
searcheable drug database.
WebMD
The WebMD Directory provides
patient-oriented information on
prescription drugs and
over-the-counter medications.