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828 Dosage > Illustrative Example--Pediatrics: Challenges to Control Performance > Flashcards

Illustrative Example--Pediatrics: Challenges to Control Performance Flashcards

1
Q

PK of drugs in pregnancy

A

-complex
-physiological changes alter ADME of drugs
-toxicity concern

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2
Q

Fetal imprinting associated disease

A

-cardiovascular disease- Barker hypothesis
-neurological disorders
-obesity/diabetes

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3
Q

Fetal imprinting

A

-affected by genetics, diet, environment etc
-very difficult to predict human effects (other factors, animal exposure studies)

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4
Q

Drug therapy for pregnant women

A

-treatment for preggo rleads to treatment of baby which we do not wnat
-66% drugs have never been tested on preggos
-exposure to environmental xenobiotics

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5
Q

Thalidomide disaster

A

-1950s sedative for morning sickness
-significantly increased phocomelia (no limbs, facial and organ deformaties)

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6
Q

Endocrine disrupting chemicals (EDCs)

A

-ex diethylstilbesterol
-in utero programing of cancer in adolescent

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7
Q

Xenobiotic exposure

A

can lead to changes in developmental PK/PD

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8
Q

1962 Kefauver-Harris Drug Amendments

A

required efficacy and safety demonstration for FDA approval and marketing

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9
Q

Legislature to promote pediatric drug development

A

FDA: pediatric plan, BPCA, PREA
EU: Pediatric investigation plan (PIP)
WHO: makes meds child sized

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10
Q

Challenges to testing drugs on kids

A

-lack of incentive (them bitches not paying)
-technology to monitor little patients (L + not enough blood)
-pediatric clinical infrastructure for drug trials

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11
Q

Pediatric approved drugs

A

-only 20-30% of drugs have pediatric labeling
-FDA encouragement (financial incentive, increased studies, requirement of new pediatric studies for drug approval)

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12
Q

Pediatric Pharmacology challenges

A

-developmental changes
-organ development
-drug transporter and metabolizing enzyme otogeny

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13
Q

Descriptive Pharmacology in pediatric patients

A

-lacking
-dosage based only on weight is not predicatble
-animal studies suck
-clinical studies upset the libs
-admin of drug also tbh

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14
Q

PREA

A

-requires companies to assess use of new drugs in pediatric patients

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15
Q

BPCA

A

financtial incentice for products studied in children

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16
Q

Pediatrics Biopharmaceutics Classification System (PBCS)

A

-solubility
-permeability
-dissolution

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17
Q

Class 1

A

rapid dissolution for immediate release

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18
Q

Class 2

A

-subclasses (a,b,c) based on acidic, basic, or neutral drugs
-dissolution criteria critically needed

19
Q

BCS Class 3

A

very rapid dissolution

20
Q

BCS Class 4

A

same as BCS class 2

21
Q

Disposition

A

-drives safety and efficacy
-need consideration and distribution, metabolism, excretion

22
Q

OATP1B1 and metotrexate (MTX)

A

-genetic variations led to clearance differences
-low clearance = higher toxicity
-must lower dose and increase hydration rates in children with this phenotype

23
Q

What factors govern down regulation of transporter expression and activity during growth and development?

A

-nuclear receptor regulation
-endocrine changes

24
Q

Pediatric drug considerations

A

Do genetic variations add to age-related variation in drug transporter expression and function?

Impact of disease, drug-gene/food/drug interactions, and exposure to environmental chemicals on the expression and function of drug transport proteins

25
Q

Challenges in studying pediatric drug transporters

A

-limited availability of quality pediatric tissue for protein quantification and assessment of transporter function
-lack of transporter specific probes to assess in vivo function
-ethical and practical challenges with performing nontherapeutic stuies in children

26
Q

Challenges with pediatrics

A

-biological
-clinical
-formulation

27
Q

biological challenges

A

-ontogenic changes
-compositional changes

28
Q

Clinical Challenges

A

-trials
-caregiver requirements

29
Q

Formulation challenges

A

-dosage form selection
-flexibility in dosing
-excipient selection
-taste masking

30
Q

EMA vs FDA

A

differing views on pediatric trials

31
Q

EMA

A

-will not allow a products release, including adult formulation, if PIP isnt satisfactory
-encourages more pediatric formulations
-could be ruining it for everyone else

32
Q

Paradigm shift

A

-protect children THROUGH research not FROM

33
Q

New challenges due to paradigm shift

A

-kids not mini adults
-kids need to be age classified
-require age appropriate formulations that used to be made through compounding
-safety and efficacy models lacking

34
Q

Safety and Toxicology of Excipients for Pediatrics Database (STEP)

A

-collaboration between EMA and NICHD
-draws attention to use of traditional excipients for kids vs adults
-encouraging greater use of solid dosage forms

35
Q

Mini-tablet Platform formulation

A

-ability to incorporate BCS class 1 and 3
-easy translation to market formulation
-minimal excipients
-same or similar manufacturing conditions
-fractional factorial DOE approach

36
Q

Ability to incorporate BCS class 1 and 3

A

-less effect of formulation
-likely more beneficial for testing meds already on market

37
Q

Easy translation to market formulation

A

-pediatric compliance
-flexible dosing
-protected from degradation of vehicle or stomach

38
Q

minimal excipients

A

single filler, disintegrant, lubricant with functional coatings

39
Q

Similar manufacturing conditions

A

-size constant
-number can fluctuate

40
Q

Fractional factorial DOE approach

A

-many process and formulation variables

41
Q

Advantages to Pharmaceutical film

A

-good for patients with dysphagia
-ease and accuracy of dosing
-increased stability
-faster onset
-life cycle management

42
Q

Disadvantages to Pharmaceutical film

A

-hard to make
-moisture sensitive
-limited dosing capacity
-increased package costs

43
Q

Remaining Pediatric Challenges

A

-age based dosage form selection
-need for descriptive pharmacology in pediatrics
-animal studies need to be refined for prediction
-enable clinical studies in children by removing ethical financial hurdles
-better routes of administration needed

828 Dosage (27 decks)

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