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CH4106 > New Drug Development and approval process > Flashcards

New Drug Development and approval process Flashcards

1
Q

Food, Drug and Comestic Act (1938)

A

Mandated testing of all drugs for harmful effects and that drug labels must be accurate and simple

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2
Q

Wheeler-Lea Act (1938)

A

Defined criteria for non-fraudulent advertising

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3
Q

Durkham-Humphney Amendment (1952)

A

Distinguish between drugs that can be sold with/without a prescription and those that cannot be refilled

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4
Q

Comprehensive Drug Abuse Prevention and Control Act (1970)

A

Categorized controlled substances based on their relative potential for abuse

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5
Q

Drug Regulation Reform Act (1978)

A

Shortened the drug investigation process to release drugs sooner to the public

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6
Q

Drug Names can be categorized into

A
  • Chemical: Precise description of the drug’s chemical composition and molecular structure
  • Generic: Name assigned to a new drug by the manufacturer who first develops the drug and is not copyrighted
  • Official: Officially assigned to a new drug and listed in official compendium
  • Trade/brand: Assigned to a new drug by its manufacturer that sells drug, copyright
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7
Q

What consist of a preclinical study?

A
  1. Chemical characterization
  2. Animal testing and screening
    - > application for IND (Investigational New Drug) status
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8
Q

What consist of a clinical study?

A

Phase 1 - healthy human volunteers
Phase 2 - human patient volunteers
Phase 3 - expansion of human patients
Application for NDA (New Drug Application)
After approval, Phase 4 - post marketing trials

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9
Q

What consist of the Drugs Design Process?

A
  1. Find lead compounds from potential drug candidates
    - Have some activity against a disease
    - May have side effects
    - Provide a starting point for structural refinements
  2. Isolate molecular bases for the disease
    Know the drug binding on proteins or nucleotides sites to tailor made a drug to bind that specific site
    Techniques used:
    - Molecular interactions
    - Rational drug design techniques (De Nova techniques)
    - X-ray crystallography
    - Distance geometry ( NMR-NOE)
  3. Drug activity refinements: Examine the molecular structure of the drug to achieve high drug activity and few side effects
    Techniques used:
    - Synthesis
    - Computational
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10
Q

What consist of a Drug Development Process?

A
  • Pharmacology
  • Metabolism
  • Toxicology
  • Preformulation
  • Formulation
  • Analytical
  • Pharmacokinetics
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11
Q

What is pharmacology?

A

Study of drugs - what they are, how they work, what they do

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12
Q

What is metabolism?

A

Biotransformation: a series of animal studies of a proposed drug’s ADME to determine:

  • extent and rate of drug absorption from various routes of administration
  • rate of drug distribution in the body, and the site(s) and duration of drug’s residence
  • rate, sites and mechanism of the drug’s metabolism and the chemistry of the metabolites
  • proportion of the administered dose eliminated from the body and its rate and route of elimination
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13
Q

What is toxicology?

A

Study of adverse/undesired effects of drugs
Determine:
- substances potential for toxicity (acute/chronic)
- substances potential for specific organ toxicity
- mode, site and degree of toxicity
- dose-response relationship for low, high and intermediate dose
- gender, reproductive or teratogenic toxicities
- substance’s carcinogenic and genotoxic potential

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14
Q

What is preformulation?

A

Application of pharmaceutical principles to the physicochemical parameters of a drug for designing an optimum drug delivery system

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15
Q

What consists of preformulation studies?

A 
Drug solubility
pKa determination
Partition coefficient
Chemical stability
Crystal properties and polymorphism
Particle size, shape and surface area
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16
Q

What is partition coefficient?

A

Measure of a drug’s lipophilicity and an indication of its ability to cross cell membranes

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17
Q

Factors affecting chemical stability

A
  1. Temperature
  2. pH
  3. Enzymes
  4. Excipients
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18
Q

What is polymorphism?

A

Drugs existing in more than 1 crystalline form with different space lattice arrangements. Polymorphs generally have different physical properties but identical chemical properties

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19
Q

Advantages of polymorphism

A
  1. When the absorption of a drug is dissolution rate limited, a more soluble and faster-dissolving polymorph may be used to increase rate and extent of bioavailability
  2. Chemically more stable polymorph -> less likely to degrade
  3. Different polymorphs -> different morphology, tensile strength and density of powder bed -> compression characteristics of materials
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20
Q

What is therapeutic index

A

TI = lethal dose (LD)/ effective dose (ED)

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21
Q

Describe phase I clinical trials

A

Takes around 2 years, 70% are sent to the next phase. Done on a small no. of healthy subjects (20-100) who take the drug to determine its safety and pharmocokinetics.
Data to be reported to FDA before proceeding

22
Q

Describe phase II clinical trials

A

Takes ~2 years, 45% are sent to the next phase.
Done on a small no, of diseased subjects (several 100s) who take the drug in gradually increasing dosages noting effectiveness and side effects
Data to be reported to FDA before proceeding

23
Q

Describe phase III clinical trials

A

5-10% pass this phase.
Extended clinical evaluation on a large no. of diseased subjects who take the drug according to protocols to determine clinical effectiveness, drug safety, and establishment of tolerated dosage

24
Q

Desribe phase IV

A
  • Identify rare adverse reactions not detected during pe-licensure studies
  • Monitor increase in known reactions
  • Identify risk factors/ pre-existing conditions that may promote reactions
  • identify particular lots with unusually high rate/types of events
25
Q

What types of controls are there?

A
  • Standard
  • Placebo
  • Comparator
  • Active drug
26
Q

What is the purpose of New Drug Application (NDA)?

A

Gain permission to market the drug product

27
Q

Factors affecting drug dosage

A
  • Characteristics of the drug
  • Drug dosage form
  • Route of administration
  • Patient factors: Age, weight, general health status, pathologic conditions, concomitant drug therapy
28
Q

What does it mean by usual adult dose?

A

Amount of drug that will produce the desired effect in most adult patients (~70kg)

29
Q

What is maintenance dose?

A

A dose sufficient to maintain at the desired level the influence of a drug achieved by earlier administration of larger amounts

30
Q

What is therapeutic dose?

A

A quantity several times larger than the maintenance dose, used in vitamin therapy when a marked deficiency exists

31
Q

What is median effective dose?

A

Amount that will produce the desired intensity of effect in 50% of the individuals

32
Q

What is drug’s half life?

A

The amount of time for half the drug to be eliminated from the system

33
Q

What is bioavailability?

A

Ability of the drug to be released from dosage form, dissolved, absorbed and transported to the site of action

34
Q

Factors to consider in Drug’s dosage response

A
  • Age
  • Weight
  • Body surface area
  • Gender: different compositions and hormone levels, water composition, pregnancy
  • Existing pathology
  • Tolerance: ability to endure the influence of a drug esp during continuous use
  • Concomitant drug therapy: drug-drug interactions: physical & chemical interactions between drugs ; interactions after ADME
  • Time and conditions of administration: before/after food (drug-food interactions)
  • Dosage form and route of administration (oral/injection)
35
Q

Factors affecting drug-dose response

A
  1. Plasma levels of a drug
  2. Biologic half-life: the time interval needed for the drug’s elimination processes to reduce the plasma conc. of the drug in the body by 1/2
  3. Therapeutic Index
36
Q

Treatment IND

A

Permits the use of an investigational drug in the treatment of patients not enrolled in the clinical study but who have serious/immediately life threatening disease for which there is no satisfactory alterative therapy
- e.g. advanced AIDS, Herpes simplex encephalitis, advanced cancer, Alzheimer’s disease, Parkinson disease
Drug must show sufficient evidence of safety and efficacy to supports its use as treatment IND

37
Q

What is prodrugs? What does it provide?

A

A compound that is converted within the body into its active form that has medical effects.
May provide improved physicochemical properties, enhanced delivery characteristics and/or therapeutic value of the drug.

38
Q

Definition of drug

A

An agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in man/other animals

39
Q

Sources of drugs

A
  • Plants, natural products e.g. Taxol, morphine, heronin (opium)
  • Humans and animals e.g. Insulin (pork, human), estrogen (horse urine)
  • Minerals e.g. Sodium bicarbonate, iron, iodine
  • Synthetic e.g. diazepam, human insulin
  • Semisynthetic e.g. Mexican yams rich in steroid structures
  • Microorganisms e.g. penicillum notatum mold (penicillin)
  • Natural vs artificial (natural - atrophine form Nightshade, quinine from cinchona bark vs artificial - savarsan, ibuprophen, acetaminophen)
40
Q

What consists of a drug selection process?

A
  1. Health needs
  2. Research objectives
  3. Company policies
41
Q

What is drug solubility?

A
  • Drugs administered by any route must have some aqueous solubility for systemic absorption and therapeutic effect
  • Affects bioavailability, rate of drug release and its therapeutic efficiency
42
Q

What is pharmacokinetics?

A

Aim to quantify drug absorption, distribution, metabolism (biotransformation), and excretion (ADME)

43
Q

Animal studies are performed to ascertain:

A
  • Toxicities of the potential new drug - acute, subacute,, subchronic and chronic toxicity
  • Therapeutic index (TI) of the potential new drug - TI = LD/ED
  • Pharmacokinetics (ADME) of the potential new drug
  • Animal testing and screening: drug tested for its biological activity on living cells and animals: in vitro screening - isolated cells, tissues and organs, in vivo screening - only with intact animals
44
Q

What is usual dose raange?

A

The quantitative range/amounts of the drug that may be prescribed safely within the framework of usual medical practice

45
Q

What is dosage regiment

A

Schedule of the dosage and depends on the drug’s duration of action, dosage form and the pharmacokinetics

46
Q

What is initial/loading/priming dose?

A

A quantity several times larger than the maintenance dose, used at the initiation of therapy to rapidly establish the desired blood and tissue levels of the drug

47
Q

Minimum effective concentration/minimum therapeutic concentration (MEC)

A

concentration of drug in the blood/plasma needed for a therapeutic effect

48
Q

Maximum therapeutic concentration/minimum toxic concentration (MTC)

A

largest amount of drug that is helpful w/o having dangerous/intolerable side effects

49
Q

Therapeutic range?

A

concentrations between MEC and MTC

50
Q

When are prodrugs useful?

A

When the active drug is too toxic to administer systematically or absorbed poorly by the digestive tract.

CH4106 (18 decks)

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