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Biocon Launches Psoriasis Drug In India; To File IND Application With US FDA This Fiscal

August 12, 2013 12:39 pm / 1 Comment on Biocon Launches Psoriasis Drug In India; To File IND Application With US FDA This Fiscal

India’s Biocon on Saturday launched ALZUMAb, a novel biologic for the treatment of psoriasis, in India. Sreeja/IB Times

KIRAN MAZUMDAR SHAW, CHAIRMAN BIOCON

itolizumab is other name

http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=5630

Jan 13: Biocon has received marketing approval in India. The company plans to file an investigational new drug application with the FDA seeking authorization for further human trials which will support regualtory approval in the US.
Biocon is to seek pre-IND advice from the US FDA .
On completing proof-of-concept PIII trials, Biocon will seek a licensing partner for itolizumab. The company has stated it expects to initiate licensing discussions during the 2010/2011 financial year

Bangalore, India-based Biocon (NSE:BIOCON) announced Saturday the launch of its first biologic drug for the treatment of chronic psoriasis in India, and said it would file an investigational new drug, or IND, application with the U.S. Food and Drug Administration, or FDA, by the end of this fiscal year.

read all at

http://www.ibtimes.com/biocon-launches-psoriasis-drug-india-file-ind-application-us-fda-fiscal-1380243

The drug, Alzumab, is the second biologic — a medicine created through a biological process and not through a chemical process — launched by the company, and is expected to serve about 1 percent to 2 percent of India’s population estimated to suffer from the ailment.

Itolizumab (INN, trade name Alzumab) is a ‘first in class’ humanized IgG1 monoclonal antibody developed by Biocon. It selectively targets CD6, a pan T cell marker involved in co-stimulation, adhesion and maturation of T cells. Itolizumab, by binding to CD6, down regulates T cell activation, causes reduction in synthesis of pro-inflammatory cytokines and possibly plays an important role by reducing T cell infiltration at sites of inflammation. A double blind, placebo controlled, phase III treat –Plaq study of itolizumab successfully met the pre-specified primary end-point of significant improvement in PASI-75 (Psoriasis Area and Severity Index) score after 12 weeks of treatment in patients with moderate to severe psoriasis compared to placebo.^[2] Biocon has received marketing authorization for the drug from the Drugs Controller General of India (DCGI).

J and J gets green light for front-line Velcade in EU

August 12, 2013 4:08 am / 6 Comments on J and J gets green light for front-line Velcade in EU

Bortezomib

Johnson & Johnson’s multiple myeloma treatment Velcade has been cleared as a first-line therapy in the EU, boosting the number of patients eligible for treatment with the drug.

The European Commission gave the go-ahead for Velcade (bortezomib) as induction therapy in combination with dexamethasone and thalidomide in previously-untreated multiple myeloma patients who are eligible for high-dose chemotherapy and a stem cell transplant.

http://www.pharmatimes.com/Article/13-08-09/J_J_gets_green_light_for_front-line_Velcade_in_EU.aspx

Bortezomib bound to the core particle in a yeast proteasome. The bortezomib molecule is in the center colored by atom type (boron = pink, carbon = cyan, nitrogen = blue, oxygen = red), surrounded by the local protein surface. The blue patch is catalyticthreonine residue whose activity is blocked by the presence of bortezomib.

Bortezomib (INN, originally codenamed PS-341; marketed as Velcade by Millennium Pharmaceuticals and Bortecad by Cadila Healthcare) is the first therapeutic proteasome inhibitor to be tested in humans. It is approved in the U.S. for treating relapsedmultiple myeloma and mantle cell lymphoma. In multiple myeloma, complete clinical responses have been obtained in patients with otherwise refractory or rapidly advancing disease.

Bortezomib was originally synthesized in 1995 (MG-341) at a company called Myogenics, which soon changed its name to ProScript. After promising preclinical results, the drug (PS-341) was tested in a small Phase I clinical trial on patients with multiple myeloma cancer. ProScript ran out of money and was bought by Leukosite in May 1999. Leukosite in turn was bought byMillennium Pharmaceuticals in October 1999. At this point in time, the project had low priority amongst other projects at the company. This changed significantly when one of the first volunteers to receive the drug in the clinical trial achieved a complete response and were still alive four years later. At the time this was a remarkable result. Later clinical experimentation indicates the possibility of a complete response in 15% of patients in a similar condition, when treated with bortezomib.

In May 2003, seven years after the initial synthesis, bortezomib (Velcade) was approved in the United States by the Food and Drug Administration (FDA) for use in multiple myeloma, based on the results from the SUMMIT Phase II trial.

Another commercially available bortezomib product – Bortenat (Natco Pharma, India), reportedly contains substantially more active entity than declared, potentially and even more resulting in increase toxicity. Moreover, Bortenat has some other chemical and formulation deviations from the registered ethic product Velcade (Millennium Pharmaceuticals and Janssen-Cilag), with unclear clinical impact

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Managing Multiple Myeloma from John Theurer Cancer Center at Hackensack University Medical Center

FDA APPROVED PRODUCT FOR PREMATURE EJACULATION

August 12, 2013 3:42 am / 9 Comments on FDA APPROVED PRODUCT FOR PREMATURE EJACULATION

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AZATHIOPRINE

August 7, 2013 7:50 am / Leave a comment

READ ALL AT

http://www.allfordrugs.com/2013/08/07/azathioprine/

The rind of the Vrikshamla (Garcinia/Garcinia indica) fruit contains an active component called hydroxycitric acid (HCA), which supports normal fat and carbohydrate metabolism, a healthy appetite level and optimum body weight

August 5, 2013 7:00 am / 56 Comments on The rind of the Vrikshamla (Garcinia/Garcinia indica) fruit contains an active component called hydroxycitric acid (HCA), which supports normal fat and carbohydrate metabolism, a healthy appetite level and optimum body weight


Kokum fruits, seeds, pulp and rinds.jpg

The rind of the Vrikshamla (Garcinia/Garcinia indica) fruit contains an active component called hydroxycitric acid (HCA), which supports normal fat and carbohydrate metabolism, a healthy appetite level and optimum body weight. The Department of Physiology researchers at the Georgetown University Medical Center in Washington DC, called Vrikshamla a safe, natural supplement for normal weight support. In an eight-week study of 60 volunteers, they reported Vrikshamla’s effectiveness in supporting normal weight, cholesterol, triglyceride and serum lipid levels.

hydroxycitric acid (HCA)

Vrikshamla grows in India the evergreen forests of the Western Ghats, the Southern Konkan region and in Goa. It is also cultivated in the Southern districts of Maharashtra and on the lower slopes of the Nilgiris mountains.

Active constituents:

The active constituent in this herb, HCA, helps weight loss by promoting normal appetite levels and by reducing the body’s ability to form adipose (fatty) tissue. HCA also reduces blood lipid levels and naturally lowers cholesterol. Other useful phytochemicals in Vrikshamla are garcinol, isogarcinol, xanthochymol and isoxanthochymol.

Herb Functions:

Weight management: The herb known to slow down the body’s ability to store fat, potentially enabling more fat from foods to pass through the body without being stored. Additionally, HCA blocks the production and storage of fat and cholesterol when calorie consumption exceeds healthy levels. The herb is also known to reduce blood lipid levels and to naturally lower cholesterol.

read at

http://www.himalayahealthcare.com/products/pharmaceuticals/vrikshamla.htm

Garcinia indica, a plant in the mangosteen family (Clusiaceae), commonly known askokum, punar puli (tulu language), is a fruit-bearing tree that has culinary, pharmaceutical, and industrial uses.

The genus Garcinia, belonging to the family Clusiaceae, includes about 200 species found in the Old World tropics, mostly in Asia and Africa. Garcinia indica is indigenous to theWestern Ghats region of India located along the western coast of the country. Of the 35 species found in India, 17 are endemic. Of these, seven are endemic to the Western Ghats, six in the Andaman and Nicobar Islands and four in the northeastern region of India.

Garcinia indica is found in forest lands, riversides and wastelands. These plants preferevergreen forests, but sometimes they also thrive in areas with relatively low rainfall. It is also cultivated on a small scale. It does not require irrigation, spraying of pesticides or fertilizers.

Garcinia indica is known by various names across India, including aamsol, aamsul, bindin, biran, bhirand,bhrinda, brinda, bin’na, kokum (alternate spellings kokam and cocum), katambi, looikya, sour apple, panarpuli, ratamba, thekera (in Assam) and many others.

The dried skin of kokum fruits

The outer cover of fruit is dried in the sun to get aamsul or kokam. It is used as a slightly sour spice in recipes from Maharashtra. Kokum yields a peculiar flavour and blackish red colour. It is a preferred substitute for tamarind in curries and other dishes from the Konkanregion. It is also used in cuisine from Gujarat, where it is frequently used to add flavor and tartness to dal (lentil soup) for flavor balance, and parts of South India.

The vessel on the left contains syrup which is obtained from the vessel containing kokum rinds, on the right. The syrup is used to make kokum sherbet

Kokum squash or kokum concentrate is used in preparing a drink (sherbet) which is bright red in colour. Kokum sherbet improves digestion and cools the body during summers^{[citation needed]}.

Further, the extract/ concentrate of this fruit is called aagal in Konkani and Marathi. It is to added during the preparation of solkadhi, along with coconut milk.

Industrial uses

The seed of Garcinia indica contains 23–26% oil, which remains solid at room temperature. It is used in the preparation of confectionery, medicines and cosmetics.

Recently, industries have started extracting hydroxycitric acid (HCA) from the rind of the fruit.^{[citation needed]}

The tree is ornamental, with a dense canopy of green leaves and red-tinged, tender, young leaves. The oily extract called kokum tel is used in foot massage.

Vivimed Acquires A US FDA Approved Formulation Manufacturing Facility

August 5, 2013 5:06 am / 1 Comment on Vivimed Acquires A US FDA Approved Formulation Manufacturing Facility

Managing Director and CEO Santosh Varalwar, vivimed labs ltd

Vivimed Labs Ltd, established in 1989, is a diversified global company with a unique portfolio of products in Specialty Chemicals and Pharmaceuticals. Vivimed has gradually increased its portfolio of offerings through product innovations at its Research & Development Center. Some of its reputed clientele includes Unilever, P&G, L’Oreal, ISP, Novartis, Merck, Cipla, Astra Zeneca, BDF, AVON and others. The Product offerings comprises Hair care, Skincare, Oral Care, Antimicrobials & Preservatives, Photo Imaging Chemicals & Photo Chromic, Specialized Formulations such as Opthalamic, Anti Ulcer, Antehelminth and other health care segments

1 aug 2013

Vivimed Labs Ltd., manufacturer of specialty chemicals and pharmaceuticals, announced the signing of an agreement to acquire Actavis Pharma Manufacturing Pvt. Ltd.’s solid oral dosage facility in Alathur in Tamil Nadu for an aggregate consideration of Rs.122 crore.

The facility is being acquired from its parent Actavis Holding Asia B.V., an affiliate of Actavis Inc., a leading global general and specialty pharmaceutical company.

read at

http://pharmadeals.pharmaintellect.com/2013/08/vivimed-acquires-us-fda-approved.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+Pharmainvest+%28PharmaInvest%29

Flow synthesis for Novartis anticancer drug, Gleevec, Imatinib

August 5, 2013 4:24 am / 4 Comments on Flow synthesis for Novartis anticancer drug, Gleevec, Imatinib

The flow-based route required minimal manual intervention and was achieved despite poor solubility of many reaction components

21 January 2013Michael Parkin

http://www.rsc.org/chemistryworld/2013/01/flow-synthesis-anticancer-drug

UK chemists have used a combination of flow chemistry methods with solid-supported scavengers and reagents to synthesise the active pharmaceutical ingredient, imatinib, of the anticancer drug Gleevec. The method avoids the need for any manual handling of intermediates and allows the drug to be synthesised in high purity in less than a day.

Gleevec, developed by Novartis, is a tyrosine kinase inhibitor used for the treatment of chronic myeloid leukaemia and gastrointestinal stromal tumours.

READ ALL AT

http://www.rsc.org/chemistryworld/2013/01/flow-synthesis-anticancer-drug



IMATINIB

CREDIT

http://www.veomed.com/va041542042010

‘Wrapping’ Gleevec Fights Drug-Resistant Cancer, Study Shows

http://www.sciencedaily.com/releases/2007/05/070501115127.htm

The anti-cancer drug Gleevec® is far more effective against a drug-resistant strain of cancer when the drug wraps the target with a molecular bandage that seals out water from a critical area. This image shows the bandage (black box) on the modified version of the drug, WBZ-7. (Credit: Image courtesy of Rice University)

A new study in Cancer Research finds that the anti-cancer drug Gleevec® is far more effective against a drug-resistant strain of cancer when the drug wraps the target with a molecular bandage that seals out water from a critical area.

FDA Grants Priority Review To New Drug Application For MNK-795

August 5, 2013 3:13 am / 3 Comments on FDA Grants Priority Review To New Drug Application For MNK-795

FDA Grants Priority Review To New Drug Application For MNK-795 Submitted By Depomed Licensee Mallinckrodt

Controlled Substance Analgesic Combination Product Uses Depomed’s Proprietary Acuform® Technology

NEWARK, Calif., July 29, 2013 /PRNewswire/ — Depomed, Inc. (NASDAQ:DEPO) announced today that the U. S. Food and Drug Administration (FDA) has accepted for filing a New Drug Application (NDA) from Mallinckrodt (NYSE: MNK) for MNK-795. MNK-795 is a controlled-release oral formulation of oxycodone and acetaminophen that has been studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. MNK-795 is formulated with Depomed’s Acuform® drug delivery technology.

http://www.pharmalive.com/fda-grants-priority-review-to-new-drug-application-for-mnk-795

Regulatory update: albiglutide US PDUFA date extended by three months

August 4, 2013 3:24 am / 2 Comments on Regulatory update: albiglutide US PDUFA date extended by three months

albiglutide,

Friday 2 August 2013, London UK

GlaxoSmithKline plc (LSE:GSK) today announced that the US Prescription Drug User Fee Act (PDUFA) goal date for albiglutide, an investigational once-weekly treatment for adult patients with type 2 diabetes, has been extended by three months to 15 April 2014 to provide time for a full review of information submitted by GSK in response to the Food and Drug Administration’s requests.

http://www.pharmalive.com/fda-delays-approval-decision-for-gsk-s-albiglutide

Albiglutide is a glucagon-like peptide-1 agonist (GLP-1 agonist) drug under investigation by GlaxoSmithKline for treatment oftype 2 diabetes. It is a dipeptidyl peptidase-4-resistant glucagon-like peptide-1 dimer fused to human albumin.

Albiglutide has a half-life of four to seven days, which is considerably longer than the other two GLP-1 analogs approved for market use, exenatide (Byetta) and liraglutide (Victoza). GLP-1 drugs are currently only available for subcutaneous administration on a daily basis, so a GLP-1 drug with a longer half-life is desirable. Such a drug would only need to be injected biweekly or weekly instead of daily, reducing the discomfort and inconvenience of GLP-1 administration considerably.

It has not yet been determined whether albiglutide is as effective an antidiabetic agent as GLP-1 drugs currently on the market, and final data remain to be published regarding the incidence of adverse effects related to the drug. To evaluate the efficacy and safety of the drug, albiglutide is undergoing eight Phase III clinical trials. Four of these trials should report useful data by end 2010

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DONEPEZIL SYNTHESIS

August 2, 2013 3:25 am / 3 Comments on DONEPEZIL SYNTHESIS

Donepezil, marketed under the trade name Aricept by its developer Eisai and partnerPfizer, is a centrally acting reversible acetylcholinesterase inhibitor. Its main therapeutic use is in the palliative treatment of Alzheimer’s disease.Common side effects include gastrointestinal upset. It has an oral bioavailability of 100% and easily crosses the blood–brain barrier. Because it has a biological half-life of about 70 hours, it can be taken once a day.

Currently, no definitive proof shows the use of donepezil or other similar agents alters the course or progression of Alzheimer’s disease (AD). However, 6 to 12-month controlled studies have shown modest benefits in cognition and/or behavior.Pilot studies have reported donepezil therapy may potentially have effects on markers of disease progression, such as hippocampal volume. Therefore, many neurologists, psychiatrists, and primary-care physicians use donepezil in patients with Alzheimer’s disease. In 2005, the UK National Institute for Clinical Excellence (NICE) withdrew its recommendation for use of the drug for mild-to-moderate AD, on the basis of no significant improvement in functional outcome, quality of life, or behavioral symptoms. However, NICE revised its guidelines to suggest donepezil be used in moderate-stage patients for whom the evidence is strongest.

While the drug is currently indicated for mild to moderate Alzheimer’s, evidence from two clinical trials also indicates it may be effective for moderate to severe disease. An example of this is a Karolinska Institute paper published in The Lancet in early 2006, which states donepezil improves cognitive function even in patients with severe AD symptoms. In Oct. 2006 the U.S. Food and Drug Administration also approved Aricept for treatment of severe dementia.

【通用名】 Donepezil hydrochloride, BNAG, E-2020, Eranz, Memorit, Memac, Aricept
【化学名】 (?-1-Benzyl-4-(5,6-dimethoxy-1-oxoindan-2-ylmethyl)piperidine hydrochloride; (?-2-(1-Benzylpiperidin-4-ylmethyl)-5,6-dimethoxyindan-1-one hydrochloride
【CAS登记号】 120011-70-3, 123958-79-2 ([2-14C]-labeled), 142057-77-0 (deleted CAS), 120014-06-4 (free base)
【分子式】 C24-H29-N-O3.Cl-H
【分子量】 415.958
【化学活性】 Alzheimer’s Dementia, Treatment of , Analgesic and Anesthetic Drugs, Antimigraine Drugs, Attention Deficit Hyperactivity Disorder (ADHD), Treatment of, Autism, Treatment of, Cognition Disorders, Treatment of, Immunologic Neuromuscular Disorders, Treatment of, Migraine, Prophylactic Treatment of, Multiple Sclerosis, Agents for, Neurologic Drugs, Psychopharmacologic Drugs, Vascular Dementia, Treatment of, Acetylcholinesterase Inhibitors
【开发阶段】 Launched-1997
【研究机构】 Eisai (Originator), National Institute of Mental Health (Not Determined), Bracco (Licensee), Pfizer (Licensee)

Donepezil inhibiting Torpedo californicaacetylcholinesterase. See Proteopedia 1eve.

Research leading to the development of donepezil began in 1983 at Eisai, and the first Phase I clinical trial took place in 1989. In 1996, Eisai received approval from the United States Food and Drug Administration (USFDA) for donepezil under the brand Aricept, which it co-marketed with Pfizer. As of 2011, Aricept was the world’s best-selling Alzheimer’s disease treatment. The first generic donepezil became available in November 2010 with the USFDA approval of a formulation prepared by Ranbaxy Labs. In April 2011 a second generic formulation, from Wockhardt, received tentative USFDA marketing approval


标题:	Cyclic amine cpd., its use and pharmaceutical compsns. comprising it
作者:	Sugimoto, H.; Tsuchiya, Y.; Higurashi, K.; Karibe, N.; Iimura, Y.; Sasaki, A.; Yamanashi, Y.; Ogura, H.; Araki, S.; Kosasa, T.; Kusota, A.; Kozasa, M.; Yamatsu, K. (Eisai Co., Ltd.)
来源:	AU 8818216; EP 0296560; EP 0673927; EP 0742207; JP 1989079151; JP 1998067739; US 4895841; US 5100901

合成路线图解说明:The condensation of 5,6-dimethoxy-1-indanone (I) with 1-benzylpiperidine-4-carboxaldehyde (II) by means of butyllithium and diisopropylamine in THF gives 1-benzyl-4-(5,6-dimethoxy-1-oxoindan-2-ylidenemethyl)piperidine (III), which is reduced with H2 over Pd/C in THF and treated with HCl in dichloromethane – ethyl acetate.


标题:	Synthesis of 1-benzyl-4-[(5,6-dimethoxy[2-14C]-1-indanon)-2-yl]methylpiperidine hydrochloride (E-2020-14C)
作者:	Sugimoto, H.; Mishima, M.; Iimura, Y.
来源:	J Label Compd Radiopharm 1989,27(7),835-9

合成路线图解说明:The condensation of 5,6-dimethoxy-1-indanone (I) with 1-benzylpiperidine-4-carboxaldehyde (II) by means of butyllithium and diisopropylamine in THF gives 1-benzyl-4-(5,6-dimethoxy-1-oxoindan-2-ylidenemethyl)piperidine (III), which is reduced with H2 over Pd/C in THF and treated with HCl in dichloromethane – ethyl acetate.



作者:	Casta馿r, J.; Prous, J.
来源:	Drugs Fut 1991,16(1),16

合成路线图解说明:The condensation of 5,6-dimethoxy-1-indanone (I) with 1-benzylpiperidine-4-carboxaldehyde (II) by means of butyllithium and diisopropylamine in THF gives 1-benzyl-4-(5,6-dimethoxy-1-oxoindan-2-ylidenemethyl)piperidine (III), which is reduced with H2 over Pd/C in THF and treated with HCl in dichloromethane – ethyl acetate.


标题:	Synthesis of 1-benzyl-4-[(5,[C-11]6-dimethoxy-1-oxoindan-2-yl)methyl]piperidine: A promising ligand for visualisation of acetylcholine esterase by PET
作者:	Santens, P.; DeReuck, J.; Dierckx, R.A.; Siegers, G.; Vermeirsch, H.; De Vos, F.
来源:	J Label Compd Radiopharm 2000,43(6),595

合成路线图解说明:11C-Labeled donepezil was prepared by methylation of 2-(1-benzylpiperidin-4-ylmethyl)-6-hydroxy-5-methoxyindan-1-one (I) with 11CH3I by means of tetrabutylammonium hydroxide in DMF.

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Drug treatment of alzheimers disease from Naser Tadvi

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Donepezil hydrochloride is a useful memory enhancer introduced by the Japanese pharmaceutical company Eisai. Its preparation was described in patent no. EP 296560. In this patent Donepezil was produced by reaction of 5,6-dimethoxy-1- indanone with 1 -benzyl-4-formylpiperidine in the presence of a strong base, such as lithium diisopropylamide followed by reduction of the double bond. According to this method, Donepezil was obtained (Scheme 1).Patent application WO 99/36405 describes another process for the synthesis of Donepezil. According to this patent, 2-alkoxycarbonyl-1-indanones are reacted with (4-pyridinyl) methyl halide moiety followed by hydrolysis and decarboxylation to give the 2-(4-pyridinyl)methyl-1-indanone derivative. This is followed by reaction with benzyl halides to obtain the corresponding quaternary ammonium salt, and followed by hydrogenation of the pyridine ring to obtain Donepezil (Scheme 2).Patent application WO 97/22584 describes the preparation of Donepezil by reaction of pyridine-4-carboxyaldehyde with malonic acid to give 3-(pyridin-4-yl)-2- propenoic acid, followed by hydrogenation of the double bond to give 3-(piperidin-4-yl)-2-propionic acid. Reaction of this intermediate with methyl chloroformate afforded 3-[N-(methyloxycarbonyl) piperidin-4-yl]propionic acid. This was followed by reaction with oxalyl chloride to give methyl 4-(2-chlorocarbonylethyl)piperidin-1-carboxylate. Reaction with 1,2-dimethoxybenzene in the presence of aluminum chloride afforded methyl 4-[3-(3,4-dimethoxyphenyl)-3-oxopropyl]piperidin-1 -carboxylate. Reaction with tetramethyldiaminomethane afforded 4-[2-(3,4-dimethoxybenzoyl)allyl] piperidin-1-carboxylate. Reaction with sulfuric acid afforded methyl 4-(5,6-dimethoxy-1-oxoindan-2-yl)methylpiperidin-1- carboxylate. This was followed by treatment with base to give 5,6-dimethoxy-2-(piperidin-4-ylmethyl) indan-1-one, then reaction with benzyl bromide afforded Donepezil (Scheme 3).

Patent application EP 711756 describes the preparation of Donepezil by reaction of 5,6-dimethoxy-1- indanone with pyridin-4-aldehyde to give 5,6-dimethoxy-2-(pyridin-4-yl)methylene indan-1-one. Reaction with benzyl bromide afforded 1-benzyl-4-(5,6-dimethoxyindan-1-on-2-ylidene)methylpyridinium bromide. Hydrogenation in the presence of platinum oxide afforded Donepezil (Scheme 4).

United States Patent 6844440

EP 1386607 A1

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Active constituents:

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The tree is ornamental, with a dense canopy of green leaves and red-tinged, tender, young leaves. The oily extract called kokum tel is used in foot massage.

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‘Wrapping’ Gleevec Fights Drug-Resistant Cancer, Study Shows

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