DRUG PRODUCT DEVELOPMENT

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

2
NEW DRUG

• doesnt 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

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

4
PRECLINICAL STUDIES

• chemical and physical properties
• biological properties
• pharmacology
• ADME
• toxicology
• Preformulation
• dosage form needs to be sterilizable, prepared in
  a reproducible fashion, stable, free of impurities

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

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

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

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

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

10
PHASE SUMMARY
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)

12
POST-MARKETING

• 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
• PHASE 4