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DRUG PRODUCT DEVELOPMENT

DRUG PRODUCT DEVELOPMENT. Drug agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in man or animals New Drug defined in section C.0 1A.001(2) of Food and Drug Regulations (HPFB)

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DRUG PRODUCT DEVELOPMENT

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  1. DRUG PRODUCT DEVELOPMENT • Drug • agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in man or animals • New Drug • defined in section C.0 1A.001(2) of Food and Drug Regulations (HPFB) • any agent that has not been generally recognized as safe and effective under the conditions recommended CHEE 440

  2. NEW DRUG • Doesn’t have to be a new chemical entity: • formulated differently / new dosage form • manufactured differently • combination of 2 or more drugs • new use for an old drug • new dosage schedule • new route of administration CHEE 440

  3. GOAL DRUG • desired features • produce desired effect • administered by desirable route • minimum dosing and dosing frequency • optimal onset and duration of activity • efficient and complete elimination • easily produced at low cost • pharmaceutically elegant • physically and chemically stable CHEE 440

  4. PRECLINICAL STUDIES • Determine chemical and physical properties • Determine biological properties: • pharmacology • ADME • toxicology • Preformulation • dosage form needs to be sterilizable, prepared in a reproducible fashion, stable, free of impurities CHEE 440

  5. IND SUBMISSION • Investigational New Drug • required before testing in humans • in Canada, filed with Health Products and Food Branch • 60 day waiting period • in USA, filed with Food and Drug Administration • 30 day waiting period CHEE 440

  6. IND Contents • manufacturer/sponsor name • proprietary name and chemical name of drug • dosage form (route of administration, ingredients, manufacture procedure, packaging, purity, labelling) • data from preclinical animal trials • relationship between preclinical and clinical trials • protocol of clinical trials • names and credentials of all persons involved in all trials • locations of laboratories used • info an any other clinical trials done in other countries CHEE 440

  7. CLINICAL TRIALS • PHASE 1 • concerned with tolerability and safety of the drug • generally involves 20-100 carefully chosen healthy volunteers • initial dose is quite low, if well tolerated, progressively larger doses given until evidence of drug action observed • determine the metabolism and pharmacological action of drug in humans CHEE 440

  8. CLINICAL TRIALS • PHASE 2 • purpose is to determine efficacy of drug (dosage) and to detect side effects not noted in healthy volunteers • patients suffering from disease are treated in limited numbers (up to several hundred) under close observation CHEE 440

  9. CLINICAL TRIALS • PHASE 3 • deals with safety and efficacy of drug • several hundred to a thousand patients • private practitioners of varying background and experience brought in by the more experienced clinicians • practitioners report to principal investigator who relays the info and his evaluation to HPFB or FDA CHEE 440

  10. PHASE SUMMARY CHEE 440

  11. NEW DRUG SUBMISSION • NDS in Canada, ND Application in US • contents • all the preclinical and clinical data • includes pharmacokinetics and bioavailability, discussion of risk and benefits, complete proposed product labeling • HPFB and FDA rule on acceptability (2-4 years) CHEE 440

  12. POST-MARKETING • PHASE 4 • Systematic and comprehensive monitoring of the patterns of use and beneficial or harmful effects of drug as used in medical practice and by the consumer CHEE 440

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