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The Development of a New Medicine
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  • By the AMS the only one point medical diagnosis and treatment conquer the cancers and recover a health from disease. This is preventive medicine. It is natural-healing. Please contact me for advance R&D(lccobok@yahoo.co.kr)
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  • In clinical trials teams of physicians carry out studies designed to determine if a medicine is safe in people and an effective treatment for the disease in question. Of the 250 compounds that enter preclinical testing, only five will make it this far. There are three phases of clinical trials: Phase I: The medicine is tested in a small group (20-100) of healthy volunteers - often in a hospital setting - to determine its safety profile, including the safe dose range. Pharmacokinetic studies examine how a drug is absorbed, distributed, metabolized and excreted, as well as the duration of its action. Phase I studies can take from six months to 18 months to complete. Phase II: Placebo-controlled trials involving approximately 100 to 500 volunteer patients who have the disease being studied. The goal of this phase is to establish the "proof of concept" - i.e., the medicine effectively treats the disease. Researchers continue to evaluate the medicines safety and look for side effects, and determine optimal dose strength and schedule (e.g., once or twice daily). Phase II studies can take from six months from one year to complete. Phase III: The medicine is tested in large, randomised, placebo-controlled trials with much larger numbers of patient volunteers - from 1,000 to 5,000, in hospitals, clinics and/or physician offices - to generate statistically significant data. Researchers closely monitor patients at regular interviews to confirm that the medicine is effective and identify side effects (also called adverse events). Phase III studies can take from one to four years to complete, depending on the disease, length of the study, and the number of volunteers. While Phase I-III studies are taking place, researchers are also conducting a number of crucial parallel studies: toxicity tests and other long-term safety evaluations; dosage forms; plans for full-scale production; package design; and preparation of the complex application required for regulatory authority approval.
  • Key preclinical tests include pharmacokinetics , the study of how medicines move through living organisms. Scientists examine four key processes - absorption, distribution, metabolism and excretion - to ensure that the medicine reaches its intended target and passes through the body properly.
  • Chemistry tests establish the compound's purity, stability and shelf life. Manufacturing tests determine what will be involved in producing the medicine on a large scale. And pharmaceutical development studies explore dosing, packaging and formulation (e.g., pill, inhaler, injection).

Transcript

  • 1. Supporting
    Irish patients
    and the
    Irish economy
    Development of a New Medicine
    Provided by the IPHA Communications Department
    May 2010
  • 2. Research Activities
    These include:
    Combinatorial libraries – vast collections of novel compounds
    Mass screening of compounds in assay systems
    Molecular biology and modern genetics – role of genes in disease states
    Recombinant DNA technology
    Computer aided molecular modelling
  • 3. Milestones in the Development
    Compound discovered and patent application made
    Submission of registration dossier to regulatory authorities
    Beginning of Human Trials
    Publication in Scientific Journal
    Trials in Patients
    Registration
    Research and Discovery
    Early Development
    Full Development
    Pre-Market Activity
    0
    5
    8
    12
    15
    Years
    * GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.
  • 4. Clinical Studies
    Preparation of initial clinical plan. Selection of clinical study locations
    PHASE II
    Trials to determine dose ranging, safety and efficacy
    PHASE III
    Large scale trials to determine definitive safety and efficacy in patients
    PHASE I
    Human trials with healthy volunteers to test tolerability
    Research and Discovery
    Early Development
    Full Development
    Pre-Market Activity
    0
    5
    8
    12
    15
    Years
    * GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.
  • 5. Toxicology
    Determine the effect on impregnation and implantation in animals and whether the active substance can affect the fetus
    Determine the reproductive effect upon future generations in animals
    Determine effects of medicine in animals when administered over 2 to 13 weeks(depending upon length of planned use in humans)
    Longer term animal studies. Does the active substance have long-term side effects?
    Test to determine mutagenic potential
    Research and Discovery
    Early Development
    Full Development
    Pre-Market Activity
    0
    5
    8
    12
    15
    Years
    * GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.
  • 6. Pharmacokinetics / Metabolism
    Determination of how the medicine is absorbed, distributed, metabolised and excreted in animals
    Determination of the effects of the medicine on specific populations such as the elderly, different races and sexes.
    Determination of how the medicine is distributed, metabolised, and excreted by humans
    Determination of how and to what extent the medicine is absorbed by humans
    Final construction of the pharmacokinetic profile of the medicine
    Research and Discovery
    Early Development
    Full Development
    Pre-Market Activity
    0
    5
    8
    12
    15
    Years
    * GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.
  • 7. Dosage Form
    Process development for large scale production of the dosage form. Testing of stability of the dosage and determination of shelf-life
    Pre-formulation activities – consultations with pharmacists / determination of physical and chemical properties of compound, e.g. particle size
    Development of clinical trial formulation
    Develop Market formulation based on known characteristics of medicine and patient group involved, e.g. age and condition. For example tablets, capsules, injectables or transdermal patches
    First dosage form for volunteer trials
    Process validation and production of the dosage form for launch
    Research and Discovery
    Early Development
    Full Development
    Pre-Market Activity
    0
    5
    8
    12
    15
    Years
    * GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.
  • 8. Active IngredientThe therapeutically active component in a medicine's final formulation that is responsible for its physiological or pharmacological action.
    Batch 0 synthesis (1st non-GMP batch)
    Batch 4 using final method of synthesis
    Batch 2 of GMP
    Batch 5 compound produced in full scale production equipment and validation
    Batch 1 synthesis (1st GMP standard)
    Final production concept
    Routine production
    Batch 3 of GMP
    Research and Discovery
    Early Development
    Full Development
    Pre-Market Activity
    0
    5
    8
    12
    15
    Years
    * GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.
  • 9. Marketing
    Early stage commercial assessment of the medicine taking into account medical need and existing therapies on the market
    Full development commercial assessment
    Trade Name ™ chosen for the medicine
    Selection of a trade name begins
    Marketing input to the design of clinical trials especially in the choice of comparator medicines
    Medicine information formulated into brochures and videos. Displays at congresses and symposia
    Profiling – development of comparative studies on, for example, specific patient groups and other similar medicines. Study possible applications of the medicine to other diseases
    Research and Discovery
    Early Development
    Full Development
    Pre-Market Activity
    0
    5
    8
    12
    15
    Years
    * GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.
  • 10. Pharmacoeconomics
    Assessment of the potential impact of the new medicine on healthcare costs
    Compilation and publication of the pharmacoeconomic results
    Economic evaluation parallel to clinical trials to determine the economic value of a new medicine, e.g. cost saving and cost-effectiveness
    Research for the appropriate pharmacoecon-omic and quality of life parameters (linked to clinical trials Phase II)
    Definition of the healthcare costs caused by the disease
    Research and Discovery
    Early Development
    Full Development
    Pre-Market Activity
    0
    5
    8
    12
    15
    Years
    * GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.
  • 11. Regulatory Affairs
    Compilation of registration dossier
    Application for trial authorisation to begin trials in patients (early development)
    Application for trial authorisation to begin trials in patients (full development)
    Application for trial authorisation to begin trials on healthy volunteers
    Formulation of medicine labelling and doctor/patient medicine information
    Review of registration documentation by regulatory authorities
    Interaction with health authorities
    Interaction with health authorities
    Interaction with health authorities
    Interaction with health authorities
    Research and Discovery
    Early Development
    Full Development
    Pre-Market Activity
    0
    5
    8
    12
    15
    Years
    * GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.
  • 12. Quick facts about Medicines Development
    • It takes an average of 10 to 12 years for a medicine to travel from the laboratory to the pharmacy shelf;
    • 13. On average, only 1 out of 5,000 to 10,000 promising substances will survive extensive testing in the R&D phase to become approved as a quality, safe and efficient marketable product;
    • 14. Several studies put the cost of researching and developing a new chemical entity €1,059 million;
    • 15. Moreover around 70% of medicines that eventually reach the market do not provide sufficient return to recoup their R&D expenditure. As a consequence, the return on investment is highly dependent on a limited number of successful products.