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PREVENTION
NUTRITION EXERCISE VACCINATION
DIAGNOSIS
TREATMENT
THERAPEUTICAL SOURCES
NUTRITIONAL BIOLOGICAL
obesity, diabetes mellitus, hypertension, peptic ulcer and osteoporosis. Blood and blood cells , Plasma, Transplantation. Haematopoietic growth factors, Biological response modifiers, Hormones. Drugs
BIO/PHARCEUTICAL
Tissular level
Cellular level
Molecular level
Captopril
Losartan
PLANT EXTRACTS
BACTERIAL BROTHS
ANIMAL VENOMS
PHARMACEUTICALS
BIOPHARMACEUTICALS
PHARMACEUTICAL
MEDICATION
Biotechnology (1982)
HISTORY OF THERAPEUTICS
724 s XIII S XIX 1906 1920 1938 Drug stores: Arabian pharmacists in Bhagdag First pharmacopeas Drug stores converted into larger pharmaceutical companies FDA creation (misbranded foods and drugs) Insulin, Penicillin were mass manufactured and distributed Toxicity studies were required
1950
Numerous drugs: the pill, cortisone, blood pressure drugs, MAO inhibitors, Thorazine, Haloperidol or Diazepam.
HISTORY OF THERAPEUTICS
1960 1962 1970 1978 1980 1982 Thalidomide Proof of efficacy was required Cancer drugs First production in India without protection Small biotech companies Rcombinant Insulin
OBJECT OF REGULATIONS
REDUCE TOXICOLOGICAL EFFECTS (1938, FDA)
Elixir Sulfanilamide
SULFANILAMIDE
Thalidomide 10,000 children in Africa and Europe were born with severe malformities
THALIDOMIDE
PRECLINICAL STUDIES
CLINICAL STUDIES
DEVELOPMENT
Rofecoxib
This has not stopped at this time, Merck 'superaspirin' became one of the top-selling drugs. In the last 2000 global sales exceeded 2,000 million euros. 1999 Goes on sale in the U.S.
JANUARY 2000 Reaches the Spanish market. MARCH 2000 A clinical trial sponsored by Merck (which compares Vioxx with a classic antiinflammatory 8000 patients) revealed that those who take Vioxx have fewer gastrointestinal problems but four times more cardiovascular risk.
AUGUST 2001 An extensive review in the journal JAMA 'challenges the cardiovascular safety of COX-2. SEPTEMBER 2001 The FDA warns Merck for failing to warn the medical advertising to coronary risk of Vioxx. APRIL 2002 The FDA mandates that change in the labeling of Vioxx. They allow to talk about their gastrointestinal benefits, but must include a warning about cardiovascular risks. JULY 2002 The Spanish Ministry of Health introduced supervision requirements for all prescriptions for COX-2. AUGUST 2004 Present data from a study conducted by the FDA: people who consume the highest dose of rofecoxib triple their cardiac risk. Rheumatologists warn Americans that are measured heart risks of COX-2 before prescribing. SEPTEMBER 2004 Merck withdrew the drug to confirm an increased risk of heart problems. Its shares fell by 27%
3-4 years
ANAESTHETICS ANALGESICS ANTIDOTES ANTI-INFECTIVE MEDICINES ANTI-MIGRAINE MEDICINES ANTINEOPLASTIC AND IMMUNODEPRESSIVES ANTIPARKINSON MEDICINES MEDICIENS AFFETING THE BLOOD BLOOD PRODUCTS AND PLASMA SUBSTITUTES CARDIOVASCULAR MEDICINES DERMATOLOGICAL MEDICINES
BLOCKBUSTERS
Category Cholesterol reducers Antiulcer compounds Antidepressants Non streroideal antiinflammatory drugs sales 2003 M$ 26.1 24.3 19.5 12.4 % increase 2002 14 9 10 6
Antipsychotic drugs
Calcium antagonists Eryhropoietine Antieplyleptic Oral anti diabetics Cephalosporines
12.2
10.8 10.1 9.4 9.0 8.3
20
2 16 22 10 10
PLANT EXTRACTS
BACTERIAL BROTHS
ANIMAL VENOMS
PHARMACEUTICALS
BIOPHARMACEUTICALS
BIOPHARMACEUTICALS
Hormones: insulin, growth hormone Thrombolytic agents Blood factors: factor VIII, factor IX Haematopietic growth: Interferons Interleukin based products Monoclonal antibodies Antisense therapy
(PHARMACOLOGY: apply scientifc priciples to make medicines more effective and less dangerous) PHARMACEUTICAL ADMINISTRATION (FORMULATION)
DISSOLUTION
BIOCHEMICAL ACTION
DG1
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Phase II