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Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned.

Therapeutic innovation & regulatory science

Sun H, Temeck JW, Chambers W, Perkins G, Bonnel R, Murphy D.
PMID: 28890858
Ther Innov Regul Sci. 2017;2017:1-7. doi: 10.1177/2168479017725558. Epub 2017 Aug 18.

BACKGROUND: "Complete Extrapolation" of efficacy from adult or other pediatric data, to the pediatric population, is an important scientific tool that reduces the need for pediatric efficacy trials. Dose finding and safety studies in pediatrics are still needed. "No...

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Sun H, Temeck JW, Chambers W, et al. Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned. Ther Innov Regul Sci. 2017;2017:1-7doi: 10.1177/2168479017725558.
Sun, H., Temeck, J. W., Chambers, W., Perkins, G., Bonnel, R., & Murphy, D. (2017). Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned. Therapeutic innovation & regulatory science, 20171-7. https://doi.org/10.1177/2168479017725558
Sun, Haihao, et al. "Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned." Therapeutic innovation & regulatory science vol. 2017 (2017): 1-7. doi: https://doi.org/10.1177/2168479017725558
Sun H, Temeck JW, Chambers W, Perkins G, Bonnel R, Murphy D. Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned. Ther Innov Regul Sci. 2017;2017:1-7. doi: 10.1177/2168479017725558. Epub 2017 Aug 18. PMID: 28890858; PMCID: PMC5587157.
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Maximal Usage Trial: An Overview of the Design of Systemic Bioavailability Trial for Topical Dermatological Products.

Therapeutic innovation & regulatory science

Bashaw ED, Tran DC, Shukla CG, Liu X.
PMID: 26634191
Ther Innov Regul Sci. 2015 Jan;49(1):108-115. doi: 10.1177/2168479014539157. Epub 2014 Jun 27.

Dermatologic diseases can present in varying forms and severity, ranging from the individual lesion and up to almost total skin involvement. Pharmacokinetic assessment of topical drug products has previously been plagued by bioanalytical assay limitations and the lack of...

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Bashaw ED, Tran DC, Shukla CG, et al. Maximal Usage Trial: An Overview of the Design of Systemic Bioavailability Trial for Topical Dermatological Products. Ther Innov Regul Sci. 2014;49(1):108-115doi: 10.1177/2168479014539157.
Bashaw, E. D., Tran, D. C., Shukla, C. G., & Liu, X. (2015). Maximal Usage Trial: An Overview of the Design of Systemic Bioavailability Trial for Topical Dermatological Products. Therapeutic innovation & regulatory science, 49(1), 108-115. https://doi.org/10.1177/2168479014539157
Bashaw, Edward Dennis, et al. "Maximal Usage Trial: An Overview of the Design of Systemic Bioavailability Trial for Topical Dermatological Products." Therapeutic innovation & regulatory science vol. 49,1 (2015): 108-115. doi: https://doi.org/10.1177/2168479014539157
Bashaw ED, Tran DC, Shukla CG, Liu X. Maximal Usage Trial: An Overview of the Design of Systemic Bioavailability Trial for Topical Dermatological Products. Ther Innov Regul Sci. 2015 Jan;49(1):108-115. doi: 10.1177/2168479014539157. Epub 2014 Jun 27. PMID: 26634191; PMCID: PMC4663190.
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Analyzing Upward Deviation of Actual vs Predicted Drug Sales in Japan for a Reasonable Drug-Pricing Policy.

Therapeutic innovation & regulatory science

Shibata S, Fukumoto D, Suzuki T, Ozaki K.
PMID: 31311310
Ther Innov Regul Sci. 2019 Jul 16;2168479019860123. doi: 10.1177/2168479019860123. Epub 2019 Jul 16.

BACKGROUND: Predictions of drug sales play an important role in setting drug prices in Japan, where drug prices are highly regulated. One of 2 primary Japanese drug-pricing methodologies-the cost calculation method- refers extensively to the prediction of drug sales...

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Shibata S, Fukumoto D, Suzuki T, et al. Analyzing Upward Deviation of Actual vs Predicted Drug Sales in Japan for a Reasonable Drug-Pricing Policy. Ther Innov Regul Sci. 2019;2168479019860123doi: 10.1177/2168479019860123.
Shibata, S., Fukumoto, D., Suzuki, T., & Ozaki, K. (2019). Analyzing Upward Deviation of Actual vs Predicted Drug Sales in Japan for a Reasonable Drug-Pricing Policy. Therapeutic innovation & regulatory science, 2168479019860123. https://doi.org/10.1177/2168479019860123
Shibata, Shoyo, et al. "Analyzing Upward Deviation of Actual vs Predicted Drug Sales in Japan for a Reasonable Drug-Pricing Policy." Therapeutic innovation & regulatory science vol. (2019): 2168479019860123. doi: https://doi.org/10.1177/2168479019860123
Shibata S, Fukumoto D, Suzuki T, Ozaki K. Analyzing Upward Deviation of Actual vs Predicted Drug Sales in Japan for a Reasonable Drug-Pricing Policy. Ther Innov Regul Sci. 2019 Jul 16;2168479019860123. doi: 10.1177/2168479019860123. Epub 2019 Jul 16. PMID: 31311310.
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Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity.

Therapeutic innovation & regulatory science

Wang J, Lon HK, Lee SL, Burckart GJ, Pisetsky DS.
PMID: 30222372
Ther Innov Regul Sci. 2015 Nov;49(6):861-868. doi: 10.1177/2168479015592195.

The field of oligonucleotide (OGN)-based therapeutics has been growing dramatically in the past decade, providing innovative platforms to develop agents for the treatment of a wide variety of clinical conditions. OGN agents have unique physicochemical properties and pharmacokinetic/pharmacodynamic characteristics....

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Wang J, Lon HK, Lee SL, et al. Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity. Ther Innov Regul Sci. 2015;49(6):861-868doi: 10.1177/2168479015592195.
Wang, J., Lon, H. K., Lee, S. L., Burckart, G. J., & Pisetsky, D. S. (2015). Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity. Therapeutic innovation & regulatory science, 49(6), 861-868. https://doi.org/10.1177/2168479015592195
Wang, Jian, et al. "Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity." Therapeutic innovation & regulatory science vol. 49,6 (2015): 861-868. doi: https://doi.org/10.1177/2168479015592195
Wang J, Lon HK, Lee SL, Burckart GJ, Pisetsky DS. Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity. Ther Innov Regul Sci. 2015 Nov;49(6):861-868. doi: 10.1177/2168479015592195. PMID: 30222372.
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Improved Label and Liver Warning for Nonprescription Acetaminophen Products.

Therapeutic innovation & regulatory science

Soller RW, Ho T, Lightwood JM.
PMID: 30222378
Ther Innov Regul Sci. 2015 Nov;49(6):890-897. doi: 10.1177/2168479015586002.

OBJECTIVE: To compare consumer preferences for a revised and current acetaminophen over-the-counter "Drug Facts" labels (ODFL) on warnings and self-reported correct intended action following signs of overdose.METHODS: Adults visiting a community center were randomly assigned to revised or current...

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Soller RW, Ho T, Lightwood JM. Improved Label and Liver Warning for Nonprescription Acetaminophen Products. Ther Innov Regul Sci. 2015;49(6):890-897doi: 10.1177/2168479015586002.
Soller, R. W., Ho, T., & Lightwood, J. M. (2015). Improved Label and Liver Warning for Nonprescription Acetaminophen Products. Therapeutic innovation & regulatory science, 49(6), 890-897. https://doi.org/10.1177/2168479015586002
Soller, R William, et al. "Improved Label and Liver Warning for Nonprescription Acetaminophen Products." Therapeutic innovation & regulatory science vol. 49,6 (2015): 890-897. doi: https://doi.org/10.1177/2168479015586002
Soller RW, Ho T, Lightwood JM. Improved Label and Liver Warning for Nonprescription Acetaminophen Products. Ther Innov Regul Sci. 2015 Nov;49(6):890-897. doi: 10.1177/2168479015586002. PMID: 30222378.
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Advances in Clinical Outcome Assessments.

Therapeutic innovation & regulatory science

Cappelleri JC, Spielberg SP.
PMID: 30222382
Ther Innov Regul Sci. 2015 Nov;49(6):780-782. doi: 10.1177/2168479015607286.

No abstract available.

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Cappelleri JC, Spielberg SP. Advances in Clinical Outcome Assessments. Ther Innov Regul Sci. 2015;49(6):780-782doi: 10.1177/2168479015607286.
Cappelleri, J. C., & Spielberg, S. P. (2015). Advances in Clinical Outcome Assessments. Therapeutic innovation & regulatory science, 49(6), 780-782. https://doi.org/10.1177/2168479015607286
Cappelleri, Joseph C, and Spielberg, Stephen P. "Advances in Clinical Outcome Assessments." Therapeutic innovation & regulatory science vol. 49,6 (2015): 780-782. doi: https://doi.org/10.1177/2168479015607286
Cappelleri JC, Spielberg SP. Advances in Clinical Outcome Assessments. Ther Innov Regul Sci. 2015 Nov;49(6):780-782. doi: 10.1177/2168479015607286. PMID: 30222382.
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Overcoming Organizational Challenges of Integrating Patient-Reported Outcomes in Oncology Clinical Trials.

Therapeutic innovation & regulatory science

Gnanasakthy A, DeMuro C.
PMID: 30222383
Ther Innov Regul Sci. 2015 Nov;49(6):822-830. doi: 10.1177/2168479015608413.

Patients with cancer frequently experience multiple symptoms that may cause significant distress and may impair physical, emotional, and social functioning and health-related quality of life. Drug development in oncology is characterized by a high attrition rate of new compounds,...

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Gnanasakthy A, DeMuro C. Overcoming Organizational Challenges of Integrating Patient-Reported Outcomes in Oncology Clinical Trials. Ther Innov Regul Sci. 2015;49(6):822-830doi: 10.1177/2168479015608413.
Gnanasakthy, A., & DeMuro, C. (2015). Overcoming Organizational Challenges of Integrating Patient-Reported Outcomes in Oncology Clinical Trials. Therapeutic innovation & regulatory science, 49(6), 822-830. https://doi.org/10.1177/2168479015608413
Gnanasakthy, Ari, and DeMuro, Carla. "Overcoming Organizational Challenges of Integrating Patient-Reported Outcomes in Oncology Clinical Trials." Therapeutic innovation & regulatory science vol. 49,6 (2015): 822-830. doi: https://doi.org/10.1177/2168479015608413
Gnanasakthy A, DeMuro C. Overcoming Organizational Challenges of Integrating Patient-Reported Outcomes in Oncology Clinical Trials. Ther Innov Regul Sci. 2015 Nov;49(6):822-830. doi: 10.1177/2168479015608413. PMID: 30222383.
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The Relationship Between Development Start Lag and Approval Lag in Oncology Drug Development in Japan.

Therapeutic innovation & regulatory science

Nakajima K, Dagher R, Strawn L, Urushidani J, Kurokawa T, Chiba K.
PMID: 30222391
Ther Innov Regul Sci. 2015 Nov;49(6):911-919. doi: 10.1177/2168479015579518.

BACKGROUND: The delay of initiation of clinical development is considered a causes of delay of approval of drugs (drug lag) in Japan.METHODS: For oncology drugs newly approved between 2000 and 2012 in Japan, a possible impact of delay of...

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Nakajima K, Dagher R, Strawn L, et al. The Relationship Between Development Start Lag and Approval Lag in Oncology Drug Development in Japan. Ther Innov Regul Sci. 2015;49(6):911-919doi: 10.1177/2168479015579518.
Nakajima, K., Dagher, R., Strawn, L., Urushidani, J., Kurokawa, T., & Chiba, K. (2015). The Relationship Between Development Start Lag and Approval Lag in Oncology Drug Development in Japan. Therapeutic innovation & regulatory science, 49(6), 911-919. https://doi.org/10.1177/2168479015579518
Nakajima, Keitaro, et al. "The Relationship Between Development Start Lag and Approval Lag in Oncology Drug Development in Japan." Therapeutic innovation & regulatory science vol. 49,6 (2015): 911-919. doi: https://doi.org/10.1177/2168479015579518
Nakajima K, Dagher R, Strawn L, Urushidani J, Kurokawa T, Chiba K. The Relationship Between Development Start Lag and Approval Lag in Oncology Drug Development in Japan. Ther Innov Regul Sci. 2015 Nov;49(6):911-919. doi: 10.1177/2168479015579518. PMID: 30222391.
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Analysis of Social Media Interactions Between Pharmaceutical Companies and Consumers: The Power of the "Like".

Therapeutic innovation & regulatory science

Jackson W, Park B, Toscani M, Hermes-DeSantis E.
PMID: 30222395
Ther Innov Regul Sci. 2015 May;49(3):387-391. doi: 10.1177/2168479014561803.

BACKGROUND: The way in which pharmaceutical companies are using social media is vitally important in staying competitive, but the way social media users respond is equally if not more important. This study aimed to evaluate the use of social...

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Jackson W, Park B, Toscani M, et al. Analysis of Social Media Interactions Between Pharmaceutical Companies and Consumers: The Power of the "Like". Ther Innov Regul Sci. 2015;49(3):387-391doi: 10.1177/2168479014561803.
Jackson, W., Park, B., Toscani, M., & Hermes-DeSantis, E. (2015). Analysis of Social Media Interactions Between Pharmaceutical Companies and Consumers: The Power of the "Like". Therapeutic innovation & regulatory science, 49(3), 387-391. https://doi.org/10.1177/2168479014561803
Jackson, William, et al. "Analysis of Social Media Interactions Between Pharmaceutical Companies and Consumers: The Power of the "Like"." Therapeutic innovation & regulatory science vol. 49,3 (2015): 387-391. doi: https://doi.org/10.1177/2168479014561803
Jackson W, Park B, Toscani M, Hermes-DeSantis E. Analysis of Social Media Interactions Between Pharmaceutical Companies and Consumers: The Power of the "Like". Ther Innov Regul Sci. 2015 May;49(3):387-391. doi: 10.1177/2168479014561803. PMID: 30222395.
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Medication Guide Reading Behaviors and Attitudes Among Subjects With Migraine, Asthma, or COPD.

Therapeutic innovation & regulatory science

Bibeau KB, DiSantostefano RL, Hinds D.
PMID: 30222399
Ther Innov Regul Sci. 2015 May;49(3):377-386. doi: 10.1177/2168479014561802.

BACKGROUND: This cross-sectional survey describes attitudes and reading behaviors toward medication guides among 785 subjects with migraine, asthma, or COPD who reported recent use of Treximet (sumatriptan/naproxen sodium) or Advair (fluticasone propionate/salmeterol).RESULTS: The survey demonstrated that the majority (82%)...

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Bibeau KB, DiSantostefano RL, Hinds D. Medication Guide Reading Behaviors and Attitudes Among Subjects With Migraine, Asthma, or COPD. Ther Innov Regul Sci. 2015;49(3):377-386doi: 10.1177/2168479014561802.
Bibeau, K. B., DiSantostefano, R. L., & Hinds, D. (2015). Medication Guide Reading Behaviors and Attitudes Among Subjects With Migraine, Asthma, or COPD. Therapeutic innovation & regulatory science, 49(3), 377-386. https://doi.org/10.1177/2168479014561802
Bibeau, Kristen B, et al. "Medication Guide Reading Behaviors and Attitudes Among Subjects With Migraine, Asthma, or COPD." Therapeutic innovation & regulatory science vol. 49,3 (2015): 377-386. doi: https://doi.org/10.1177/2168479014561802
Bibeau KB, DiSantostefano RL, Hinds D. Medication Guide Reading Behaviors and Attitudes Among Subjects With Migraine, Asthma, or COPD. Ther Innov Regul Sci. 2015 May;49(3):377-386. doi: 10.1177/2168479014561802. PMID: 30222399.
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A Trial Activation Initiative to Accelerate Trial Opening in an Academic Medical Center.

Therapeutic innovation & regulatory science

Choi YJ, Jeon H, Kim S, In Y, Park SY, Park M, Park S, Lee Y, Kim S, Kim KP, Koo HY, Kim TW.
PMID: 30222419
Ther Innov Regul Sci. 2015 Mar;49(2):234-238. doi: 10.1177/2168479014554399.

Delays in trial opening should be considered critical for the sake of not only the sponsor but the patients, as they may result in inequities of care. The Asan Medical Center, in Seoul, Korea, implemented a trial activation initiative...

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Choi YJ, Jeon H, Kim S, et al. A Trial Activation Initiative to Accelerate Trial Opening in an Academic Medical Center. Ther Innov Regul Sci. 2015;49(2):234-238doi: 10.1177/2168479014554399.
Choi, Y. J., Jeon, H., Kim, S., In, Y., Park, S. Y., Park, M., Park, S., Lee, Y., Kim, S., Kim, K. P., Koo, H. Y., & Kim, T. W. (2015). A Trial Activation Initiative to Accelerate Trial Opening in an Academic Medical Center. Therapeutic innovation & regulatory science, 49(2), 234-238. https://doi.org/10.1177/2168479014554399
Choi, Yun Jung, et al. "A Trial Activation Initiative to Accelerate Trial Opening in an Academic Medical Center." Therapeutic innovation & regulatory science vol. 49,2 (2015): 234-238. doi: https://doi.org/10.1177/2168479014554399
Choi YJ, Jeon H, Kim S, In Y, Park SY, Park M, Park S, Lee Y, Kim S, Kim KP, Koo HY, Kim TW. A Trial Activation Initiative to Accelerate Trial Opening in an Academic Medical Center. Ther Innov Regul Sci. 2015 Mar;49(2):234-238. doi: 10.1177/2168479014554399. PMID: 30222419.
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Risk Minimization Activities and Measures of Effectiveness: A New Approach.

Therapeutic innovation & regulatory science

Valentino R.
PMID: 30222424
Ther Innov Regul Sci. 2015 Jul;49(4):599-600. doi: 10.1177/2168479015570338.

No abstract available.

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Valentino R. Risk Minimization Activities and Measures of Effectiveness: A New Approach. Ther Innov Regul Sci. 2015;49(4):599-600doi: 10.1177/2168479015570338.
Valentino, R. (2015). Risk Minimization Activities and Measures of Effectiveness: A New Approach. Therapeutic innovation & regulatory science, 49(4), 599-600. https://doi.org/10.1177/2168479015570338
Valentino, Rudolph. "Risk Minimization Activities and Measures of Effectiveness: A New Approach." Therapeutic innovation & regulatory science vol. 49,4 (2015): 599-600. doi: https://doi.org/10.1177/2168479015570338
Valentino R. Risk Minimization Activities and Measures of Effectiveness: A New Approach. Ther Innov Regul Sci. 2015 Jul;49(4):599-600. doi: 10.1177/2168479015570338. PMID: 30222424.
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Showing 1 to 12 of 707 entries