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2042 > weeks 1-3 > Flashcards

weeks 1-3 Flashcards

1
Q

Target product profile

A
  • Defines the minimal/ideal profile marketed product
  • shows ultimate goals of the proposed therapy development effort i.e. disease indication, patient population, delivery mode, treatment regimen and standards of clinical efficacy.
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2
Q

sections of the TPA not contained in the the FDA document that the sponsor might want to consider

A
  • primary markets
  • pharmacoecenomics
  • cost of goods
  • target price
  • current gold standard
  • possible market extensions
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3
Q

Efficacy component of TPP

A

Efficacy: Drives PK/PD attributes of the candidate via stipulation of a magnitude and duration of effect; drives evaluation of alternative molecular and formation strategies.

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4
Q

Safety component of TPP

A

drives side effect profile, what is tolerated and what is not
Toxicity in some cases

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5
Q

Quality component of a TTP

A
  • defines shelf life(dictated in part by formulation)
  • packaging (diff. grades vs shelf life cost)
  • quality testing components
  • need for particular excipients
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6
Q

NDA

A

the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing

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7
Q

Required information for the summary of the NDA

A
  • proposed text of the labelling, support for the inclusion of each statement on the labelling
  • identify the pharmacologic class of the drug, intended use and the potential therapeutic benefits
  • CMC
  • Non clinical pharmacology and toxicology
  • human pharmacokinetics and bioavailibility section
  • clinical data
  • post marketing
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8
Q

Composition of drug product

A

-Drug substance + dosage form

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9
Q

Factors influencing dose form

A

Physicochemical/biopharmaceutical properties of the drug,

  • chemical and physical stability
  • metabolic processe
  • cultural and personal preferences
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10
Q

Solid state aspects

A

Different solid state forms; polymorphs, salts and amorphous forms
- Tests = XRD, Raman Microscopy

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11
Q

Biopharmaceutical classification system

A

1) high solubility High permeability
2) low solubility, high permeability
3) High solubility, low permeability
IV) Low solubility, Low permeability

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12
Q

Limiting factors of bioavailability

A
  • Lipinski values outside the rule of 5 (remember there are only 4 rules)
  • phsyiological facotrs (metabolism and efflux)
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13
Q

specifications

A

A set of tests and limits which are applied to the product in order to ensure that every batch is of satisfactory and consistent quality throughout its shelf life

  • should also describe the label, container etc
  • cannot be altered without generating a new specification with a different specification number (coz its a new product)
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14
Q

Internal uses of the specification

A
  • describes the product
  • QC, is it okay for market
  • Batch testing
  • internal dossier of important info
  • API sourcing/manufacturing
  • Regulatory affairs
  • Technical development
  • Familiarity training purposes
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15
Q

External uses of the specification

A
  • Submission for reg. approval
  • Basis for the certificate of Assurance/ Batch record
  • Pseudo product information
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16
Q

Product spec vs batch record

A
  • Batch record shows values obtained from tests, indicates if the criteria was met
  • has the batch number
17
Q

Format of product spec

A
  • Date
  • author
  • approver
  • company name
  • document number
  • name of product
  • pack size

Body: physical description and container description

  • active ingredients with limits and test methods
  • excipients
  • tests
18
Q

Pharmacopoeia

A
  • exist to provide standards ensuring the quality of medicines
  • provide controlled standardised tests, analytical methods and acceptance criteria for establishing the quality of: API, Excipients. formulated product
19
Q

Medicinal substance monograph

A

Defines the API i.e. Acetyl Salicylic acid

1: introductory(structure, CAS number, preparations etc)
2: Identification (methods A +B)
3: tests i.e. appearance on solution, Heavy metals, loss on drying. Related substances
4: assays, how much is there

20
Q

General monographs

A

Specific to the dose form: provides guidance for determining the quality of medicines prepared from said dose form

  1. Definition
  2. production
  3. tests
  4. storage
21
Q

Specific monographs

A

For complete finished products, basically medicinal and general monographs combined

22
Q

Appendices

A 
Standard solutions
Buffers
Analytical Methods
Detail of the Test methods eg dissolution
Detailed Test Apparatus

2042 (17 decks)

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