Role and Necessisity Of Clinical Trials in Drug Research and Development

DEPENDING UP ON THE TYPE OF DRUG GOING FOR CLINICAL TRAILS SELECTION CRITERIA VARIES HERE I AM INCLUDING THE GENERAL CRITERIA ALONG WITH REFERENCES PLS SEE...

GENERAL CRITERIA:
Inclusion Criteria:

Normal healthy adult subjects between 20-40 years of age.
Body weight within 80-120% of ideal body weight. Ideal body weight = (height-80)0.7
Acceptable medical history and physical examination including:

Normal chest X-ray and ECG results within six months prior to Period I dosing.
No particular clinical significance in general disease history within two months prior to Period I dosing.
Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to Period I dosing, which includes:

AST (SGOT)
ALT (SGPT)
Gama-GT
alkaline phosphatase
total bilirubin
albumin
glucose
BUN
uric acid
creatinine
total cholesterol
triglyceride(TG)
Acceptable hematology within two months prior to the study, which includes hemoglobin, hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells, differential white blood cells and platelets.
Acceptable urinalysis within two months prior to the study, which includes pH, blood, glucose and protein.
Signed the written informed consent to participate in this study.
Exclusion Criteria:

Recent history of drug or alcohol addiction or abuse.
A clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
History of allergic response(s) to nalbuphine or related drugs.
History of clinically significant allergies including drug allergies or allergic bronchial asthma.
Evidence of chronic or acute infectious diseases.
Any clinically significant illness or surgery during the four weeks prior to Period I dosing (as determined by the clinical investigator).
Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.
Receiving any investigational drug within one month prior to Period I dosing.
Taking any prescription medication or any nonprescription medication within two weeks prior to Period I doing.
Donating greater than 150 ml of blood within two months prior to Period I dosing or donating plasma (e.g., plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
Consumption of caffeine, xanthine-containing products (i.e., coffee, tea, caffeine-containing sodas, colas and chocolate, etc.) and/or alcohol at least 48 hours prior to days on which dosing is scheduled and during the periods when blood samples are being collected.
Any other medical reason as determined by the clinical investigator.
Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline.
REFERNCE: http://clinicaltrials.gov/ct2/show/NCT00924079

ANY DRUG NEEDED TO BE UNDERGO CLINICAL TRAILS WHILE IT HITTING THE MARKET WHETHERE IT IS SWINE FLU OR AIDS IT DOESN'T MATTER..
regards

Blinded, randomized trials
Many Phase III trials are randomized, double-blind trials. Randomized means people are assigned at random either to receive the new drug, the standard treatment for that disease, or a nonfunctional substitute (such as a sugar pill). This last group is often called the control group, or the placebo group. Because phase III must answer definitively whether the drug works, it's important to compare people who receive it with others who do not.

Open trials

Not every trial is blind. In unblinded trials, often described as open trials, both doctors and participants know what treatments are being given. Trials of surgical procedures and comparisons of medical devices are often by nature open. One of the problems with an open drug trial is that many participants may not want to take placebos, because they presume the drug will be better. Open trials, like single-blind trials, are considered to be more prone to error than double-blind procedures.

Factorial trials

When patients are being treated with a combination of drugs, as is current practice for HIV infection, a new drug may be evaluated by testing it in combination with other drugs rather than by itself. A factorial design trial may be used for this purpose. A simple factorial design would have one group testing therapy A, another testing therapy B, a third group testing A and B combined, and a control group testing neither A nor B. Factorial designs are considered an efficient way to test medicines in combination, but their results are not always easy to interpret.

Crossover trials

In a crossover trial, each participant gets both treatments being tested. Some participants are assigned at random to receive drug A, and later, drug B. Others receive B, then A. To produce valid results, the effect of the first drug must end before the second drug is taken, and vice-versa. This requirement can be hard to satisfy, and is one reason crossover trials are not often used.

Orphan Drug Trials

Orphan drug trials test drugs designed to treat diseases affecting fewer than 200,000 Americans. Some are rare genetic diseases that occur when missing or defective enzymes prevent essential biochemical reactions from happening. Because affected individuals are so few, an orphan drug may be tested only on a small number of participants, who generally are so sick that if the drug works, their improved health is readily apparent.

REFERENCE: http://www.genetichealth.com/resources_types_of_clinical_trials.shtml

THANKS FOR YOUR QUERIES,
1)BOTH DRUG AS WELL AS DOASGE FORM ARE SUBJECTED FOR CLINICAL TRAILS.
REFERENCE: http://books.google.co.in/books?id=AuK6R-J2UFEC&pg=PA487&lpg=PA487&dq=CL...
2)INCLUSION CRITERIA:
Normal healthy adult subjects between 20-40 years of age.
Body weight within 80-120% of ideal body weight. Ideal body weight = (height-80)0.7

Acceptable medical history and physical examination including:
Normal chest X-ray and ECG results within six months prior to Period I dosing.
No particular clinical significance in general disease history within two months prior to Period I dosing.

Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to Period I dosing, which includes:
AST (SGOT)
ALT (SGPT)
Gama-GT
alkaline phosphatase
total bilirubin
albumin
glucose
BUN
uric acid
creatinine
total cholesterol
triglyceride(TG)
Acceptable hematology within two months prior to the study, which includes hemoglobin, hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells, differential white blood cells and platelets.
Acceptable urinalysis within two months prior to the study, which includes pH, blood, glucose and protein.
Signed the written informed consent to participate in this study.

EXCLUSION CRITERIA:
Recent history of drug or alcohol addiction or abuse.
A clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
History of allergic response(s) to nalbuphine or related drugs.
History of clinically significant allergies including drug allergies or allergic bronchial asthma.
Evidence of chronic or acute infectious diseases.
Any clinically significant illness or surgery during the four weeks prior to Period I dosing (as determined by the clinical investigator).
Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.
Receiving any investigational drug within one month prior to Period I dosing.
Taking any prescription medication or any nonprescription medication within two weeks prior to Period I doing.
Donating greater than 150 ml of blood within two months prior to Period I dosing or donating plasma (e.g., plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
Consumption of caffeine, xanthine-containing products (i.e., coffee, tea, caffeine-containing sodas, colas and chocolate, etc.) and/or alcohol at least 48 hours prior to days on which dosing is scheduled and during the periods when blood samples are being collected.
Any other medical reason as determined by the clinical investigator.
Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline.
REFERENCE: http://clinicaltrials.gov/ct2/show/NCT00924079

3)For many, the word "thalidomide" conjures up images of babies born with shortened or missing arms and legs. Between 1957 and the early 1960s, thalidomide was used by several thousand pregnant women across the world to ease their morning sickness. But many who took thalidomide in the early stages of pregnancy gave birth to babies with severe birth defects.

Now, decades later, thalidomide isn't used for morning sickness. But it has received approval from the Food and Drug Administration (FDA) to treat one skin condition and a type of cancer, and it's being investigated as a treatment for many other disorders.
Thalidomide has also demonstrated usefulness in treatment of multiple myeloma — a blood and bone marrow cancer. In May 2006, the FDA approved thalidomide, in conjunction with dexamethasone, for the treatment of newly diagnosed multiple myeloma. Thalidomide appears to slow the growth of myeloma cells and prevent them from attaching to bone marrow cells.
REFERENCE: http://www.mayoclinic.com/health/thalidomide/HQ01507
4)EXCIPIENTS ARE ALSO SUBMITTED FOR CLINICAL TRAILS
HERE THE REFERENCE FOR MY ANSWER: http://clinicaltrials.gov/ct2/show/NCT00522678

MADAM TAKING DRUG DISCOVERY AS AN CAREER NEEDS LOTS OF PATIENT ALONG WITH KNOWLEGED... ITS ONES OWN INTEREST. DRUG DISCOVERY AND CLINICAL TRAILS HAVE THEIR OWN LIMITATIONS...

MANY DRUGS ARE THERE , DRUGS FAILED AT PHASE IV CLINICAL TRAILS( Post Marketing Surveillance Trial)..

EXAMPLES..recent examples involve cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).

REFERNCE: http://en.wikipedia.org/wiki/Clinical_trial#Phase_IV

Regards..

THANKS FOR UR VALUABLE COMMENT.

STATUS OF CLINICAL TRAILS IN INDIA,
Clinical trials of bio-tech and medicinal products for approval purposes are done usually in hospitals in India. Most of the hospitals conduct clinical trials, if they have doctors interested in this activity. Information on the terms and conditions and the cost is not readily available.

All types of hospitals carry out clinical trials, large and small as also municipal and government hospitals. Large private hospitals and clinics too perform this work. The basic requirement is the presence of doctors who have an interest in this work.

On the basis of preliminary enquiries, there are already companies or agencies engaged exclusively for clinical trials in India. Examples are Quintiles in Ahmedabad, Clinfarm Consultants and Specialty Ranbaxy in Mumbai and Kumar in New Delhi. Quintiles and Specialty Ranbaxy have foreign tie-ups giving them the technological advantage over the purely local ones.
REFERENCE: http://www.indiaonestop.com/clinicaltrials.htm#Status of clincial trials in India

CLINICAL TRAILS LABORATORIES:
Central Drug Research Institute (CDRI)
Chattar Manzil Palace
P.B. No 173
Lucknow - 226001
Tel: (+91) 522 232411
Fax: (+91) 522 243405
Website: http://www.cdriindia.org

Centre for Cellular & Molecular Biology (CCMB)
RRL Campus
Uppal Road
Hyderabad - 500007
Andhra Pradesh, India.
Tel: (+91 40) 2716 0222 - 41
Fax: (+91 40) 2716 0591, 2716 0311
E-mail: lalji@ccmb.res.in
Website: http://www.ccmb.res.in

Indian Institute of Chemical Biology (IICB)
4, Raja S. C. Mullick Road
Calcutta - 700032
Tel: (+91 33) 2473 3492, 2473 0492
Fax: (+91 33) 2473 0286
E-mail: director@iicb.res.in
Website: http://www.iicb.res.in

Institute of Microbial Technology (IMT)
Post Box No 1304
Sector 39-A
Chandigarh - 160036, India.
Tel: (+91 172) 695225, 695226, 694710, 695219, 690713, 690173, 690908, 690025
Fax: (+91 172) 690632
Website: http://imtech.res.in

OM-First Limited
Ahmedabad, India.
Tel: (91 79) 404 849
Fax: (91 79) 656 6103
E-mail: omfirst@ad1.vsnl.net.in
Has office in London as well.
E-mail in London: INFO@OMFIRST.CO.UK
Contact person in London: Paresh Patel.

Quintiles Spectral Limited
3 Ashoknagar Bungalows
Behind Sundarvan
Satellite Road
Ahmedabad 380 015
Tel: (+91 79) 692 3303
Fax: (+91 79) 692 4311
Email: rajiv.ramanathan@quintiles.com
Website: http://www.quintiles.com

Specialty Ranbaxy Limited
Plot 113, MIDC 15th Street
Andheri (East)
Mumbai - 400 093
Tel: (91 22) 5690 3851
Fax: (91 22) 5690 3865
e-mail: cservice@srlranbaxy.com
Website: http://www.srlranbaxy.com

Metropolis Health Services (India) Pvt. Ltd.
250 D, Udyog Bhavan,
Hind Cycle Marg
Behind Glaxo
Worli, Mumbai - 400 030
Tel: 91-22-56622040, 91-22-56611067
Fax: 91-22-56622080
Email: support@metropolisindia.com
Website: http://www.metropolisindia.com

REFERENCE: http://www.indiaonestop.com/clinicaltrials.htm#Status of clincial trials in India

IN INDIA WE CAN GET KNOWLEGED PROFESSIONAL FOR LOW FAIR ALONG WITH THAT IN INDIA ALL TYPES OF PATIENTS AS WELL AS HEALTHY VOLUNTRIES ARE AVAILABLE AT LOW COST FOR BETTER RESEARCH.

1) Any drug needed to pass all the phases ....... if one phase get fails .... it needed to be discarded fully...........

reference: http://www.assocham.org/events/recent/event_278/_dr._kiran_v._marthak.pdf
2)few drugs are there but to my point its confidential for that company..( not able to say openly .. i have my own limits )

recent examples involve cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).

REFERENCE: http://en.wikipedia.org/wiki/Clinical_trial#Phase_IV

The mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making. This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base.

reference : http://www.who.int/ictrp/en/

COMPANY NAME TRADE NAME GENERIC NAME CONDITION(S),PHASES(S)
1.pfizer N/A AG-014699 ovarian cancer,II , Breast cancer, II
2.pfizer N/A CP-751871 Breast cancer,II,sarcoma,II,AdreanalcancerII
3.pfizer N/A PF-04554878 cancer(unspecified),I
4.pfizer N/A PF-299804 Lung cancer,I/II, solid tumors,I

reference:1)cancer drugs http://www.centerwatch.com/drug-information/pipeline/

Geneva - Novartis, the Swiss drug-maker, began its clinical trials for a vaccine for swine flu.Melbourne-based CSL, part of the international CSL Group, was the first to report a clinical trial in July, saying 240 people were receiving an experimental vaccine. China's Hualan biomedical company also said it began testing.

reference: 2) http://www.monstersandcritics.com/news/health/news/article_1493443.php/N...

Regards..

1) There are no.of regulatory bodies around world, pls refer this link http://www.pharmweb.net/pwmirror/pwk/pharmwebk.html#int
http://www.pharmainfo.net/regulatory-zone/worldwide-regulatory-agencies
2)Regulatory Authorities: Bodies having the power to regulate. In the ICH good clinical practice (GCP) guideline, the expression "Regulatory Authorities" includes the authorities that review submitted clinical data and those that conduct inspections. These bodies are sometimes referred to as competent authorities. reference :
http://clinicaltrials.ifpma.org/fileadmin/files/pdfs/Glossary.pdf
4)The United States Food and Drug Administration (FDA) has defined bioequivalence as, "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study." (FDA, 2003)
http://en.wikipedia.org/wiki/Bioequivalence
5)For a pharmacokinetic comparison, the plasma concentration data are used to assess key pharmacokinetic parameters such as area under the curve (AUC), peak concentration (Cmax), time to peak concentration (Tmax), and absorption lag time (tlag). Testing should be conducted at several different doses, especially when the drug displays non-linear pharmacokinetics.
http://en.wikipedia.org/wiki/Bioequivalence

Regards