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11 Diseases |  |
8 Trials |
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8 Trials |  |
513 News |  |
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- | Eucrisa (crisaborole) / Pfizer
Trial completion date, Trial primary completion date, Patient reported outcomes: ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis (clinicaltrials.gov) - Jan 12, 2021
P3, N=160, Recruiting, Sponsor: University of Rochester
Trial completion date: Jan 2021 --> Aug 2021 | Trial primary completion date: Jan 2021 --> Jul 2021
- || Eucrisa (crisaborole) / Pfizer
Clinical, P4 data, PK/PD data, Journal: Safety, Effectiveness, and Pharmacokinetics of Crisaborole in Infants Aged 3 to < 24 Months with Mild-to-Moderate Atopic Dermatitis: A Phase IV Open-Label Study (CrisADe CARE 1). (Pubmed Central) - Jan 6, 2021
P4
Trial completion date: Jan 2021 --> Aug 2021 | Trial primary completion date: Jan 2021 --> Jul 2021 In this open-label study, crisaborole was well tolerated and effective in infants (3 to < 24 months) with mild-to-moderate AD with systemic exposures similar to patients aged ≥ 2 years.
- Eucrisa (crisaborole) / Pfizer
[VIRTUAL] Evaluating the Severity of Atopic Dermatitis in Children and Adults: Mapping of Investigator’s Static Global Assessment to Eczema Area and Severity Index in Phase 3 Studies of Crisaborole, 2% () - Jan 5, 2021 - Abstract #RAD2020RAD_114;
P3
A limitation of this study is that most patients in literature articles examining EASI strata were adults. CONCLUSIONS Mapping of ISGA to EASI scores was investigated using data from clinical trials to present results in terms of mapped EASI scores.
- topical roflumilast cream (ARQ-151) / Arcutis
[VIRTUAL] The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05% in Atopic Dermatitis: Phase 2 Proof-of-Concept Study () - Jan 5, 2021 - Abstract #RAD2020RAD_91;
Both doses of roflumilast (0.15% and 0.05%) had a favorable safety profile, with a low rate of application site reactions. This study suggests that roflumilast cream, a potent PDE-4 inhibitor, represents a potential effective QD treatment for AD.
- || Eucrisa (crisaborole) / Pfizer
Trial completion date, Trial primary completion date: Steroid-reducing Effects of Crisaborole (clinicaltrials.gov) - Dec 14, 2020
P4, N=60, Recruiting, Sponsor: Johns Hopkins University
This study suggests that roflumilast cream, a potent PDE-4 inhibitor, represents a potential effective QD treatment for AD. Trial completion date: Nov 2020 --> Dec 2022 | Trial primary completion date: Nov 2020 --> Dec 2021
- ||| Eucrisa (crisaborole) / Pfizer
Enrollment open: Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis (clinicaltrials.gov) - Dec 14, 2020
P2, N=92, Recruiting, Sponsor: Pfizer
Trial completion date: Nov 2020 --> Dec 2022 | Trial primary completion date: Nov 2020 --> Dec 2021 Active, not recruiting --> Recruiting
- | Eucrisa (crisaborole) / Pfizer
Trial completion date, Trial primary completion date, Adherence: Eucrisa for Atopic Dermatitis (clinicaltrials.gov) - Dec 7, 2020
P1, N=40, Active, not recruiting, Sponsor: Wake Forest University Health Sciences
Active, not recruiting --> Recruiting Trial completion date: Mar 2021 --> Jun 2021 | Trial primary completion date: Dec 2020 --> Mar 2021
- ||| Eucrisa (crisaborole) / Pfizer
Enrollment closed, Enrollment change: A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD (clinicaltrials.gov) - Dec 4, 2020
P3b/4, N=178, Active, not recruiting, Sponsor: Pfizer
Trial completion date: Mar 2021 --> Jun 2021 | Trial primary completion date: Dec 2020 --> Mar 2021 Recruiting --> Active, not recruiting | N=600 --> 178
- |||| Eucrisa (crisaborole) / Pfizer
Enrollment closed, Trial completion date, Trial primary completion date: A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - Dec 1, 2020
P3, N=150, Active, not recruiting, Sponsor: Pfizer
Recruiting --> Active, not recruiting | N=600 --> 178 Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Dec 2020 | Trial primary completion date: Jul 2023 --> Dec 2020
- Humira (adalimumab) / Eisai, AbbVie, Differin (adapalene) / Galderma, Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
[VIRTUAL] Therapeutic Update () - Nov 26, 2020 - Abstract #FCPANP2020FCPANP_61;
Similar concepts have allowed combination of halobetasol .01% and tazarotene .045%, calcipotriene as a foam and halobetasol as a lotion...Goldenberg also highlighted new topicals including tapinarof and a topical PDE-4 inhibitor, roflumilast...Goldenberg then summarized updates on biologics for the management of psoriasis including: the improved hemoglobin A1c and weight control in diabetic patients with psoriasis on Otezla (PDE-4 inhibitor); long-term safety of tumor necrosis factor biologics adalimumab and certolizumab pegol as well as the ability for patients to self-administer certolizumab at home; the enduring efficacy of IL-17 blockers including congruent patient-reported data for ixekizumab, sustained long-term response data for secukinumab to 52 weeks and for brodalumab to 60 weeks; data demonstrating that although IL-17 blockers (specifically secukinumab) may work faster, guselkumab had a higher proportion of patients reach PASI 90/100 by week 48 and that rizankizumab outperformed adalimumab in moderate to severe plaque psoriasis management; and finally promising results for tyrosine kinase 2 inhibitors improving quality of life in psoriasis patients...Goldenberg closed with a brief discussion of advancements in management of viral dermatoses (single-use cantharidin for molluscum, buccal-adhesive acyclovir tablets), personal care moisturizers, and augmenting sun protection with polypodium leucotomos. Overall, regardless of which niche in dermatology you practice in, there are sure to be exciting therapeutic advancements coming your way.
- | Eucrisa (crisaborole) / Pfizer
Biomarker, Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: SMART: Skin bioMARkers for Atopic Eczema Therapy Evaluation (clinicaltrials.gov) - Nov 24, 2020
P2, N=37, Recruiting, Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Overall, regardless of which niche in dermatology you practice in, there are sure to be exciting therapeutic advancements coming your way. Not yet recruiting --> Recruiting | Trial completion date: Apr 2021 --> Apr 2022 | Initiation date: Mar 2020 --> Nov 2020 | Trial primary completion date: Apr 2021 --> Jan 2022
- | tacrolimus / Generic mfg.
Journal: Atopic Dermatitis: Diagnosis and Treatment. (Pubmed Central) - Nov 21, 2020
Evidence is lacking to support the use of integrative medicine in the treatment of atopic dermatitis. Newer medications approved by the U.S Food and Drug Administration, such as crisaborole and dupilumab, are effective in treating atopic dermatitis but are currently cost prohibitive for most patients.
- Eucrisa (crisaborole) / Pfizer
[VIRTUAL] EFFICACY OF CRISABOROLE IN PATIENTS WITH MILD-TO-MODERATE ATOPIC DERMATITIS WITH AND WITHOUT COMORBID ALLERGIC RHINITIS () - Nov 21, 2020 - Abstract #ACAAI2020ACAAI_591;
P3
ISGA clear or almost clear at day 29 occurred in 55.9% (48.0%-63.8%) vs 29.2% (18.8%-39.6%) with PMH of AR (difference, p<0.0001) and 49.0% (45.4%-52.6%) vs 36.6% (31.3%-41.8%) without PMH of AR (difference, p=0.0001). No new safety concerns were identified.Conclusions Crisaborole is efficacious and safe in treating patients with mild-to-moderate AD regardless of PMH of AR.
- Eucrisa (crisaborole) / Pfizer
[VIRTUAL] EFFICACY OF CRISABOROLE IN PATIENTS WITH MILD-TO-MODERATE ATOPIC DERMATITIS WITH AND WITHOUT FOOD ALLERGIES () - Nov 21, 2020 - Abstract #ACAAI2020ACAAI_571;
P3
Treatment-related adverse events (crisaborole vs vehicle) occurred in 8.6% vs 9.2% with FA and in 7.2% vs 4.0% without FAs. No new safety concerns were identified.Conclusions Crisaborole is effective and safe in treating mild-to-moderate AD in patients with and without FAs.
- | Eucrisa (crisaborole) / Pfizer
Preclinical, Journal: Ex vivo (human skin) and in vivo (minipig) permeation of propylene glycol applied as topical crisaborole ointment, 2. (Pubmed Central) - Nov 19, 2020
In the in vivo minipig study, the bioavailability of PG after dermally applied crisaborole ointment was 3.56% for unabraded skin and 3.65% for abraded skin. Experimental values from this study can serve to provide scientific justification for using a product's specific absorption value, as opposed to a maximum absorption of 100%, when attempting to estimate systemic exposure of PG from a topical product.
- | Eucrisa (crisaborole) / Pfizer
Journal: A New Generation of Treatments for Itch. (Pubmed Central) - Nov 19, 2020
These include crisaborole, several interleukin antagonists, and janus kinase inhibitors. The promising results presented with these new antipruritic therapies allow physicians to be better equipped to treat their itchy patients.
- | Eucrisa (crisaborole) / Pfizer
Journal: Topical Agents for the Treatment of Atopic Dermatitis (Pubmed Central) - Nov 7, 2020
Approval of the new topical phosphodiesterase 4 inhibitor crisaborole ointment, 2%, to treat mild-to-moderate atopic dermatitis (AD) warrants careful consideration of available efficacy and safety data for topical therapies to contribute to a better understanding of the role of crisaborole in the treatment of mild-to-moderate AD...2020;19(1):50-64. doi:10.36849/JDD.2020.4508
- || Eucrisa (crisaborole) / Pfizer, Dupixent (dupilumab) / Sanofi, Regeneron
Review, Journal: Immunosuppressive and Immunomodulating Therapy for Atopic Dermatitis in Pregnancy: An Appraisal of the Literature. (Pubmed Central) - Nov 5, 2020
The selected studies reflect the authors' assessment regarding originality and importance in the context of this appraisal. It is always the treating doctor's responsibility to stay updated on current literature when treating patients, especially pregnant patients.
- ||| Eucrisa (crisaborole) / Pfizer
Enrollment closed, Enrollment change: Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis (clinicaltrials.gov) - Nov 5, 2020
P2, N=1, Active, not recruiting, Sponsor: Pfizer
It is always the treating doctor's responsibility to stay updated on current literature when treating patients, especially pregnant patients. Recruiting --> Active, not recruiting | N=92 --> 1
- || Eucrisa (crisaborole) / Pfizer
@pfizer eucrisa has been prescribed for me as the steroid alternatives are not effective. I DON'T HAVE $684.00! (Twitter) - Oct 20, 2020
- Eucrisa (crisaborole) / Pfizer
[VIRTUAL] Efficacy of topical crisaborole for treating mild-to-moderate seborrheic dermatitis () - Oct 20, 2020 - Abstract #EADV2020EADV_2991;
- Eucrisa (crisaborole) / Pfizer
[VIRTUAL] Real-Life Experience With Crisaborole (Room: 4 - Crocker) - Oct 20, 2020 - Abstract #EADV2020EADV_1169;
Recruiting --> Active, not recruiting | N=92 --> 1 Pfizer (HCPs Only)
- Eucrisa (crisaborole) / Pfizer
[VIRTUAL] Clinical Profile of Crisaborole (Room: 4 - Crocker) - Oct 20, 2020 - Abstract #EADV2020EADV_1168;
Pfizer (HCPs Only) Pfizer (HCPs Only)
- Eucrisa (crisaborole) / Pfizer
[VIRTUAL] Evaluating the Severity of Atopic Dermatitis (AD) in Children and Adults- Mapping of Investigator's Static Global Assessment (ISGA) to Eczema Area and Severity INDEX (EASI) in Phase 3 Studies of Crisaborole, 2% () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_570;
P3
A limitation is that most patients in articles for EASI strata were adults. CONCLUSIONS : Mapping of ISGA to EASI scores was investigated using data from clinical trials to present results in terms of the EASI.
- |||| Eucrisa (crisaborole) / Pfizer
Enrollment open: A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - Oct 1, 2020
P3, N=150, Recruiting, Sponsor: Pfizer
CONCLUSIONS : Mapping of ISGA to EASI scores was investigated using data from clinical trials to present results in terms of the EASI. Not yet recruiting --> Recruiting
- || Eucrisa (crisaborole) / Pfizer
Clinical, P1 data, Journal: Phase 1 study of crisaborole in Japanese healthy volunteers and patients with atopic dermatitis. (Pubmed Central) - Sep 27, 2020
Crisaborole was rapidly absorbed, with limited systemic exposure between days 1 and 8 that was comparable with that seen in US-based participants in previous trials. Crisaborole had higher skin irritation than vehicle under occlusion in healthy Japanese adults and had an acceptable safety profile in Japanese adults with mild to moderate AD.
- ||| Eucrisa (crisaborole) / Pfizer
Clinical: 1 month treatment with crisaborole in children ages 3 to 24 months lead to skin being clear to almost clear in 47% of participants. (Twitter) - Sep 11, 2020
- ||| Eucrisa (crisaborole) / Pfizer
Crisaborole is a PDE4 inhibitor, a small molecule containing boron (Twitter) - Sep 11, 2020
- || Eucrisa (crisaborole) / Pfizer
Trial completion date, Trial primary completion date: A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD (clinicaltrials.gov) - Sep 10, 2020
P3b/4, N=600, Recruiting, Sponsor: Pfizer
Crisaborole had higher skin irritation than vehicle under occlusion in healthy Japanese adults and had an acceptable safety profile in Japanese adults with mild to moderate AD. Trial completion date: Mar 2021 --> Mar 2023 | Trial primary completion date: Mar 2021 --> Mar 2023
- | Journal: Drugs for atopic dermatitis. (Pubmed Central) - Sep 8, 2020
Trial completion date: Mar 2021 --> Mar 2023 | Trial primary completion date: Mar 2021 --> Mar 2023 No abstract available
- |||||| Eucrisa (crisaborole) / Pfizer
Enrollment open, Enrollment change: Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - Aug 31, 2020
P3, N=732, Recruiting, Sponsor: Pfizer
No abstract available Not yet recruiting --> Recruiting | N=510 --> 732
- Eucrisa (crisaborole) / Pfizer
Efficacy and safety of crisaborole in patients ≥3 months of age with mild-tomoderate atopic dermatitis (AD) (Ponce Exhibit Hall 1, 2, & 3,) - Aug 28, 2020 - Abstract #EAC2020EAC_58;
P3, P4
Based on these studies, crisaborole was well tolerated and effective in adults, adolescents, children, and infants ≥3 months of age with mild-to-moderate AD. Funding: Pfizer Inc.
- Eucrisa (crisaborole) / Pfizer
Efficacy and safety trends with continuous long-term use of crisaborole ointment, 2%, in patients with mild-to-moderate atopic dermatitis (Ponce Exhibit Hall 1, 2, & 3,) - Aug 28, 2020 - Abstract #EAC2020EAC_57;
Continuous long-term crisaborole use was well Tolerated. Funding: Pfizer Inc.
- Eucrisa (crisaborole) / Pfizer
Efficacy and safety of crisaborole in patients ≥3 months of age with mild-tomoderate atopic dermatitis (AD) (Ponce Exhibit Hall 1, 2, & 3,) - Aug 28, 2020 - Abstract #EAC2020EAC_17;
P3, P4
Based on these studies, crisaborole was well tolerated and effective in adults, adolescents, children, and infants ≥3 months of age with mild-to-moderate AD. Funding: Pfizer Inc.
- Eucrisa (crisaborole) / Pfizer
Efficacy and safety trends with continuous long-term use of crisaborole ointment, 2%, in patients with mild-to-moderate atopic dermatitis (Ponce Exhibit Hall 1, 2, & 3,) - Aug 28, 2020 - Abstract #EAC2020EAC_16;
Continuous long-term crisaborole use was well Tolerated. Funding: Pfizer Inc.
- ||| Eucrisa (crisaborole) / Pfizer
.@JessicaSimpson reveals lifelong struggle with #eczema & finding relief with #eucrisa, having her #vegan husband try to trick her with @BeyondMeat burgers, #quarantine #workouts, #pandemic #parenting, and turning 40: https://t.co/hvotafuRWu @SELFmagazine @pfizer #JessicaSimpson (Twitter) - Aug 24, 2020
- || Eucrisa (crisaborole) / Pfizer
Clinical, Journal: Crisaborole 2% ointment for the treatment of intertriginous, anogenital, and facial psoriasis: a double-blind, randomized, vehicle-controlled trial. (Pubmed Central) - Aug 23, 2020
Funding: Pfizer Inc. Treatment with crisaborole 2% ointment was well-tolerated and led to clinical improvement in participants with intertriginous, anogenital, or facial psoriasis.
- Eucrisa (crisaborole) / Pfizer, Kerydin (tavaborole) / Pfizer
[VIRTUAL] Design and synthesis of novel classes of hemiboronic heterocycles and a preliminary evaluation of their structure, physical and biological properties, and synthetic transformations (On Demand Oral) - Aug 20, 2020 - Abstract #ACSFall2020ACS-Fall_5707;
These studies will help evaluate the potential utility of these new compounds in drug discovery, biochemical studies, and will guide the design of further classes of boron heterocycles. Additionally, to demonstrate their synthetic utility, we investigate the scope of reactions these new classes can undergo, including orthogonal cross-coupling reactions.
- | Eucrisa (crisaborole) / Pfizer
Journal: An Update on the Latest Developments in Nonsteroidal Topical Therapy for Atopic Dermatitis. (Pubmed Central) - Aug 18, 2020
Modes of action, including phosphodiesterase-4 inhibition, aryl hydrocarbon receptor activation, and Janus kinase inhibition are discussed. Emphasis is placed on therapeutic approaches related to modes of action, with clinical data included.
- ||| Eucrisa (crisaborole) / Pfizer
Trial completion, Enrollment change: Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea (clinicaltrials.gov) - Aug 17, 2020
P2, N=8, Completed, Sponsor: Duke University
Emphasis is placed on therapeutic approaches related to modes of action, with clinical data included. Recruiting --> Completed | N=20 --> 8
- | Eucrisa (crisaborole) / Pfizer
Trial completion date, Trial primary completion date, Adherence: Eucrisa for Atopic Dermatitis (clinicaltrials.gov) - Aug 8, 2020
P1, N=40, Active, not recruiting, Sponsor: Wake Forest University Health Sciences
Recruiting --> Completed | N=20 --> 8 Trial completion date: Aug 2020 --> Mar 2021 | Trial primary completion date: Aug 2020 --> Dec 2020
- |||||||| Eucrisa (crisaborole) / Pfizer
New P3 trial: A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - Aug 7, 2020
P3, N=150, Not yet recruiting, Sponsor: Pfizer
- | Eucrisa (crisaborole) / Pfizer, Daliresp (roflumilast) / AstraZeneca, Takeda, AbbVie, Otezla (apremilast) / Amgen
Journal, Cytokine storm: Commentary: Phosphodiesterase 4 inhibitors as potential adjunct treatment targeting the cytokine storm in COVID-19. (Pubmed Central) - Aug 4, 2020
Interestingly, obesity and diabetes mellitus type 2 have been reported to be risk factors for the severity of COVID-19. Therefore, randomized clinical trials of PDE4 inhibitors are necessary to explore their potential therapeutic effect as an adjunct to supportive measures and other therapeutic regiments.
- | Eucrisa (crisaborole) / Pfizer
Trial primary completion date: Different Application Rates of Crisaborole Ointment 2% in Adults With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - Jul 17, 2020
P4, N=30, Recruiting, Sponsor: Innovaderm Research Inc.
Therefore, randomized clinical trials of PDE4 inhibitors are necessary to explore their potential therapeutic effect as an adjunct to supportive measures and other therapeutic regiments. Trial primary completion date: Jun 2020 --> Nov 2020
- | Eucrisa (crisaborole) / Pfizer
Review, Journal: Soft drugs for dermatological applications: recent trends. (Pubmed Central) - Jul 10, 2020
The literature is rapidly growing of successful examples of compounds targeting sphingosine-1-phosphate receptor 1 (S1PR1), transient receptor potential vanilloid 1 (TRPV1), Janus kinase (JAK), caspase 1, and histone deacetylase (HDAC), for the treatment of skin inflammatory, autoimmune, and oncological diseases. As a demonstration of the potential of this strategy, the SD approach recently led to the approval of crisaborole, a soft phosphodiesterase 4 (PDE4) inhibitor, for atopic dermatitis, while other agents are in clinical development.
- ||| Eucrisa (crisaborole) / Pfizer
Enrollment open: Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis (clinicaltrials.gov) - Jul 8, 2020
P2, N=92, Recruiting, Sponsor: Pfizer
As a demonstration of the potential of this strategy, the SD approach recently led to the approval of crisaborole, a soft phosphodiesterase 4 (PDE4) inhibitor, for atopic dermatitis, while other agents are in clinical development. Not yet recruiting --> Recruiting
- Decadron (dexamethasone) / Merck (MSD)
[VIRTUAL] Validation of an atopic dermatitis model in mice by repeated intra-dermal challenges with ovalbumin () - Jul 1, 2020 - Abstract #SID2020SID_495;
The current results show that AD-like symptoms can be induced in mice with repeated intra-dermal challenges with ovalbumin in the ear. This could eliminate the technical challenges involved with epicutaneous application of protein allergens for induction of AD models.
- Stelara (ustekinumab) / J&J
[VIRTUAL] Comparing molecular cutaneous improvement in atopic dermatitis with various treatment modalities facilitates personalized approaches () - Jul 1, 2020 - Abstract #SID2020SID_485;
For example, Th22/IL-22 targeting with fezakinumab is particularly efficacious in improving the AD barrier dysfunction, but induces only modest changes in skin inflammation. Our approach may facilitate future development of a personalized medicine approach in AD by identifying the best treatments for individual phenotypes and patients needs, based on immune, barrier, and atherosclerosis profiles.
- Eucrisa (crisaborole) / Pfizer
[VIRTUAL] Crisaborole in patients ≥3 months of age with mild-to-moderate atopic dermatitis (AD) () - Jul 1, 2020 - Abstract #SID2020SID_438;
P3, P4
In CARE 1, 30.2% of patients achieved ISGA success at day 29, consistent with that observed for crisaborole-treated patients in AD-301/AD-302 (32.5%; 2-6 years, 30.5%; 7-11 years, 36.6%; 12-17 years, 30.3%; ≥18 years, 29.7%). Based on these studies, crisaborole was well tolerated and effective in patients ≥3 months of age with mild-to-moderate AD.
- Eucrisa (crisaborole) / Pfizer
[VIRTUAL] Patient and disease characteristic predictors of systemic exposure to crisaborole () - Jul 1, 2020 - Abstract #SID2020SID_437;
Disease severity, race, and sex had marginal effects on AUCss and Cmaxss. Model predictions indicated that, at similar treated percentage of body surface area, crisaborole systemic exposures across age groups are expected to be in a similar range, and systemic exposures in children (>3 months of age) at maximum possible dose are unlikely to exceed the systemic exposures at the maximum possible dose in adults.