Gemini pharmaceuticals and marketing
The pharmaceutical industry discovers, develops, produces, and markets drugs or gemini pharmaceuticals and marketing drugs for use as medications. They are subject to a variety of laws and regulations that govern the patentingtesting, safety, efficacy and marketing of drugs.
The modern pharmaceutical gemini pharmaceuticals and marketing traces its roots to two sources. The first of these were local apothecaries that expanded from their traditional role distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid s. By the late s, German dye manufacturers had perfected the purification of individual organic compounds from coal tar and other mineral sources and had also established rudimentary methods in organic chemical synthesis.
By the s, the profound effect of adrenal extracts on many different tissue types had been discovered, setting off a search both for the mechanism of chemical signalling and efforts to exploit these observations for the development of new drugs. The blood pressure raising and vasoconstrictive effects of adrenal extracts were of particular interest to surgeons as hemostatic agents and as treatment for shock, and a number of companies developed products based on adrenal extracts containing varying purities gemini pharmaceuticals and marketing the active substance.
InJohn Abel of Johns Hopkins University identified the active principle gemini pharmaceuticals and marketing epinephrinewhich he isolated in an impure state as the sulfate salt. Industrial chemist Jokichi Takamine later developed a method for obtaining epinephrine in a pure state, and licensed the technology to Parke-Davis. Parke-Davis marketed epinephrine under the trade name Adrenalin. Injected epinephrine proved to be especially efficacious for the acute treatment of asthma attacks, and an inhaled version was sold in the United States until Primatene Mist.
While highly effective, the requirement for injection limited the use of epinephrine [ clarification needed ] and orally active derivatives were sought. A structurally similar compound, ephedrineactually more similar to norepinephrinewas identified by Gemini pharmaceuticals and marketing chemists in the Ma Huang plant and marketed by Eli Lilly as an oral treatment for asthma.
Following the work of Henry Dale and George Barger at Burroughs-Wellcome, academic chemist Gordon Alles synthesized amphetamine and tested it in asthma patients in The drug proved to have only modest anti-asthma effects, but produced sensations of exhilaration and palpitations. Amphetamine was developed by Smith, Kline and French as a nasal decongestant under the trade name Benzedrine Gemini pharmaceuticals and marketing. Amphetamine was eventually developed for the treatment of narcolepsypost-encephalitic parkinsonism gemini pharmaceuticals and marketing, and mood elevation in depression and other psychiatric indications.
It received approval as a New and Nonofficial Remedy from the American Medical Association for these uses in and remained in common use for depression until the development of tricyclic antidepressants in the s. InHermann Emil Fischer and Joseph von Mering disclosed their discovery that diethylbarbituric acid, formed from the reaction of diethylmalonic acid, phosphorus oxychloride and gemini pharmaceuticals and marketing, induces sleep in dogs. The discovery was patented and licensed to Bayer pharmaceuticalswhich marketed the compound under the trade name Veronal as a sleep aid beginning in Systematic investigations of the effect of structural changes on potency and duration of action led to the discovery of phenobarbital at Bayer in and the discovery of its potent anti-epileptic activity in Phenobarbital was among the most widely used drugs for the treatment of epilepsy through gemini pharmaceuticals and marketing s, and as ofgemini pharmaceuticals and marketing on the World Health Organizations list of essential medications.
Today, amphetamine is largely restricted to use in the treatment of attention deficit disorder and phenobarbital in the treatment of epilepsy. A series of experiments performed from the late s to the early s revealed that diabetes is caused by the absence of a substance normally produced gemini pharmaceuticals and marketing the pancreas. InOskar Minkowski and Joseph von Mering found that diabetes could be induced in dogs by surgical removal of the pancreas. InCanadian professor Frederick Banting and his student Charles Best repeated this study, and found that injections of pancreatic extract reversed the symptoms produced by pancreas removal.
Soon, the extract was demonstrated to work in people, but development of insulin therapy as a routine medical procedure was delayed by difficulties in producing the material in sufficient quantity and with reproducible purity. The researchers sought assistance from industrial collaborators at Eli Lilly and Co. Walden of Eli Lilly and Company found that careful adjustment of the pH of the extract allowed a relatively pure grade of insulin to be produced. Under pressure from Toronto University and a potential patent challenge by academic scientists who had independently developed a similar purification method, an agreement was reached for non-exclusive production of insulin gemini pharmaceuticals and marketing multiple companies.
Prior to the discovery and widespread availability of insulin therapy the life expectancy of diabetics was only a few months. In arsphenaminethe first synthetic anti-infective drug, was developed by Paul Ehrlich and chemist Alfred Bertheim of the Institute of Experimental Therapy in Berlin. The drug was given the commercial name Salvarsan. Arsphenamine was prepared as part of a campaign to synthesize a series of such compounds, and found to exhibit partially selective toxicity.
Arsphenamine proved to be the gemini pharmaceuticals and marketing effective treatment for syphilisa disease which prior to that time was incurable and led inexorably to severe skin ulceration, neurological damage, and death. Ehrlich's approach of systematically varying the chemical structure of synthetic compounds and measuring the effects of these changes on biological activity was pursued broadly by gemini pharmaceuticals and marketing scientists, including Bayer scientists Josef Klarer, Fritz Mietzsch, gemini pharmaceuticals and marketing Gerhard Domagk.
This work, also based in the testing of compounds available from the German dye industry, led to the development of Prontosilthe first representative of the sulfonamide class of antibiotics. Compared to arsphenamine, the sulfonamides had a broader spectrum of activity and were far less toxic, rendering them useful gemini pharmaceuticals and marketing infections caused by pathogens such as streptococci. InAlexander Fleming gemini pharmaceuticals and marketing the antibacterial effects of penicillinbut its exploitation for the treatment of human disease awaited the development of methods for its large scale production and purification.
These were developed by a U. Early progress toward the development of vaccines occurred throughout this period, primarily in the form of academic and government-funded basic research directed toward the identification of the pathogens responsible for common communicable diseases. The first diphtheria vaccines were gemini pharmaceuticals and marketing in from a gemini pharmaceuticals and marketing of diphtheria toxin and antitoxin produced from the serum of an inoculated animalbut the safety of the inoculation was marginal and gemini pharmaceuticals and marketing was not widely used.
The United States recordedcases of diphtheria in resulting in 15, deaths. In parallel efforts by Gaston Ramon at the Pasteur Institute and Alexander Glenny at the Wellcome Research Laboratories later part of GlaxoSmithKline led to the discovery that a safer vaccine could be produced by treating diphtheria toxin with formaldehyde.
Prior to the 20th century drugs were generally produced by small scale manufacturers with little regulatory control over manufacturing or claims of safety and efficacy. To the extent that such laws did exist, enforcement was lax. In the United States, increased regulation of vaccines and other biological drugs was spurred by tetanus outbreaks and deaths caused by the distribution of contaminated smallpox vaccine and diphtheria antitoxin.
This was followed in by the Pure Food and Drugs Actwhich forbade the interstate distribution of adulterated or misbranded foods and drugs.
A drug was considered misbranded if it contained alcohol, morphine, opium, cocaine, or any of several other potentially dangerous or addictive drugs, and if its label failed to indicate the quantity or proportion of such drugs. The government's attempts to use the law to prosecute manufacturers for making unsupported claims of efficacy were undercut by a Supreme Court ruling restricting the federal government's enforcement powers to cases of incorrect specification of the drug's ingredients.
In over people died after ingesting " Elixir Sulfanilamide " manufactured by S. Massengill Company of Tennessee. The product was formulated in diethylene glycola highly toxic solvent that is now widely used as antifreeze. In response to this gemini pharmaceuticals and marketing, the U. Congress passed the Federal Food, Drug, and Cosmetic Act ofwhich for the first time required pre-market demonstration of safety before a drug could be sold, and explicitly prohibited false therapeutic claims.
The aftermath of World War II saw an explosion in the discovery of new classes of antibacterial drugs [25] including the cephalosporins developed by Eli Lilly based on the seminal work of Giuseppe Brotzu gemini pharmaceuticals and marketing Edward Abraham[26] [27] streptomycin discovered during a Merck-funded research program in Selman Waksman's laboratory [28]the tetracyclines [29] discovered at Lederle Laboratories, now a part of Pfizererythromycin discovered at Eli Lilly and Co.
Streptomycin, discovered during a Merck-funded research program in Selman Waksman's laboratory at Rutgers inbecame the first effective treatment for tuberculosis.
A Federal Trade Commission report issued in attempted to quantify the effect of antibiotic development on American public health. The report concluded that "it appears that the use of antibiotics, early diagnosis, and other factors have limited the epidemic spread and thus the number of these diseases which have occurred".
During the gemini pharmaceuticals and marketingthe rate of decline in the U. The dramatic decline in the immediate post-war years has gemini pharmaceuticals and marketing attributed to the rapid development of new treatments and vaccines for infectious disease that occurred during these years. The vaccine process was never patented, but was instead given to pharmaceutical companies to manufacture as a low-cost generic.
In the United States Cancer Institute announced that it had gemini pharmaceuticals and marketing that SV40 gemini pharmaceuticals and marketing not associated with cancer in people.
Hypertension is a risk factor for atherosclerosis, [40] heart failure[41] coronary artery disease[42] [43] stroke[44] renal disease[45] [46] and peripheral arterial disease[47] [48] and is the most important risk factor for cardiovascular morbidity and mortalityin industrialized countries. Severe cases of hypertension were treated by surgery. Early developments in the field of treating hypertension included quaternary ammonium ion sympathetic nervous system blocking agents, but these compounds were never widely used due to their severe side effects, because the long term health consequences of high blood pressure had not yet been established, and because they had to be administered by injection.
In researchers at Ciba discovered the first orally available vasodilator, hydralazine. In the mids Karl H. Baer, and Frederick C. Novello of Merck and Co. A Cochrane review concluded that thiazide antihypertensive drugs reduce the risk of death RR 0. ACE inhibitors reduce the risk of new onset kidney disease [RR 0. Prior to the second world war, birth control was prohibited in many countries, and in the United States even the discussion of contraceptive methods sometimes led to prosecution under Comstock laws.
The history of the development of oral contraceptives is thus closely tied to the birth control movement and the efforts of activists Margaret SangerMary Dennettand Emma Goldman. Based on fundamental research performed by Gregory Pincus and synthetic methods for progesterone developed by Carl Djerassi at Syntex and by Frank Colton at G.
The original formulation incorporated vastly excessive doses of hormones, and caused severe side effects. Nonetheless, by1. The hearings covered a wide range of policy issues, including advertising abuses, questionable efficacy of drugs, and the need for greater regulation of the industry. While momentum for new legislation temporarily flagged under extended debate, a new tragedy emerged that underscored the need for more comprehensive regulation and provided the driving force for the passage of new laws.
On 12 Septemberan American licensee, the William S. Merrell Company of Cincinnati, submitted a new drug application for Kevadon thalidomidea sedative that had been marketed in Europe since The FDA medical officer in charge of reviewing the compound, Frances Kelseybelieved that the data supporting the safety of thalidomide was incomplete.
The firm continued to pressure Kelsey and the FDA to approve the application until Novembergemini pharmaceuticals and marketing the drug was pulled off the German market because of its association with grave congenital abnormalities. Several thousand newborns in Europe and elsewhere suffered the teratogenic effects of thalidomide. Without approval from the FDA, the firm distributed Kevadon to over 1, physicians there under the guise of investigational use. Over 20, Americans received thalidomide in gemini pharmaceuticals and marketing "study," including pregnant patients, and about 17 known newborns suffered the effects of the drug.
The thalidomide tragedy resurrected Kefauver's gemini pharmaceuticals and marketing to enhance drug regulation that had stalled in Congress, and the Kefauver-Harris Amendment became law on 10 October gemini pharmaceuticals and marketing Manufacturers henceforth had to prove to FDA that their drugs were effective as well as safe before they could go on the US market. The FDA received authority to regulate advertising of prescription drugs and to establish good manufacturing practices.
The law required that all drugs introduced between and had to be effective. An FDA - National Academy of Sciences collaborative study showed that nearly 40 percent of these products were not gemini pharmaceuticals and marketing. A similarly comprehensive study of over-the-counter products began ten years later.
InAkira Endo, a Japanese biochemist working for the pharmaceutical company Sankyo, identified mevastatin MLBa molecule produced by the fungus Penicillium citrinum, as an inhibitor of HMG-CoA reductase, a critical enzyme used by the body to produce cholesterol.
Animal trials showed very good inhibitory effect as in clinical trialshowever a long term study in dogs found toxic effects at higher doses and as a result mevastatin was believed to be too toxic for human use. Mevastatin was never marketed, because of its adverse effects of tumors, muscle deterioration, and sometimes death in laboratory dogs. ByMerck had isolated lovastatin mevinolin, MK from the fungus Aspergillus terreusfirst marketed in as Mevacor. Researchers tested simvastatinlater sold by Merck as Zocor, on 4, patients with high cholesterol and heart disease.
For his "pioneering research into a new class of molecules" for "lowering cholesterol," [ sentence fragment ] [69] [70]. Drug discovery is the process by which potential drugs are discovered or designed.