Scientific and Regulatory Considerations for Development and Commercialization of Poorly Water-Soluble Drugs | AAPS Advances in the Pharmaceutical Sciences Series | 2022 |
Pharmacokinetic peculiarities of drugs used in the form of rapidly dispersible tablets (oral delivery system) | | 2020 |
Scientific and Regulatory Considerations for Development and Commercialization of Poorly Water-Soluble Drugs | AAPS Advances in the Pharmaceutical Sciences Series | 2016 |
Public Databases and Sources of Information of Interest to Medicinal Chemistry Addiction Researchers | | |
Bioequivalence for Topical Drug Products | AAPS Advances in the Pharmaceutical Sciences Series | 2014 |
Buprenorphine for opioid dependence: Are there really differences between the formulations? | Mental Health Clinician | 2014 |
Combined Language Processing Methods and Mash-Up System for Improving Retrieval in Diabetes Related Patents | Lecture Notes in Computer Science | 2014 |
Clinical Endpoint Bioequivalence Study | AAPS Advances in the Pharmaceutical Sciences Series | 2014 |
Intellectual Property Protection Strategies for Biotechnology Innovations | | 2020 |
Cutaneous Pharmacokinetics of Acyclovir Cream 5% Products: Evaluating Bioequivalence with an In Vitro Permeation Test and an Adaptation of Scaled Average Bioequivalence | Pharmaceutical Research | 2020 |
Bioequivalence and Therapeutic Equivalence of Generic and Brand Bupropion in Adults With Major Depression: A Randomized Clinical Trial | Clinical Pharmacology and Therapeutics | 2019 |
Cyclo-oxygenase selectivity and chemical groups of nonsteroidal anti-inflammatory drugs and the frequency of reporting hypersensitivity reactions: a case/noncase study in VigiBase | Fundamental and Clinical Pharmacology | 2019 |
Patent term restoration for top-selling drugs in the United States | Drug Discovery Today | 2019 |
Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012 | JAMA Internal Medicine | 2018 |
Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014 | Clinical Pharmacology and Therapeutics | 2018 |
The United States of America | AAPS Advances in the Pharmaceutical Sciences Series | 2017 |
China | AAPS Advances in the Pharmaceutical Sciences Series | 2017 |
The US Food and Drug Administration's tentative approval process and the global fight against HIV | Journal of the International AIDS Society | 2017 |
Risk-Based Bioequivalence Recommendations for Antiepileptic Drugs | Current Neurology and Neuroscience Reports | 2017 |
Development of Oral Flexible Tablet (OFT) Formulation for Pediatric and Geriatric Patients: a Novel Age-Appropriate Formulation Platform | AAPS PharmSciTech | 2017 |
Nanosizing techniques for improving bioavailability of drugs | Journal of Controlled Release | 2017 |
The global intellectual property ecosystem for insulin and its public health implications: an observational study | Journal of Pharmaceutical Policy and Practice | 2017 |
BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements | AAPS Journal | 2016 |
Reducing Illicit Methamphetamine Labs: Is Precursor Control the Answer? | Journal of Drug Policy Analysis | 2016 |
Which patent and where? Why international patent transparency by companies is needed for medicines | Nature Biotechnology | 2016 |
Access to Medications for Cardiovascular Diseases in Low- and Middle-Income Countries | Circulation | 2016 |
Arrhythmia associated with buprenorphine and methadone reported to the Food and Drug Administration | Addiction | 2016 |
Nanodrugs in Medicine and Healthcare: Oral Delivery | | 2016 |
Could patents interfere with the development of a cardiovascular polypill? | Journal of Translational Medicine | 2016 |
Trends in chemoradiation use in elderly patients with head and neck cancer: Changing treatment patterns with cetuximab | Head and Neck | 2016 |
Is Patent "Evergreening" Restricting Access to Medicine/Device Combination Products? | PLoS ONE | 2016 |
Nanocrystals for enhancement of oral bioavailability of poorly water-soluble drugs | Asian Journal of Pharmaceutical Sciences | 2015 |
SAR and QSAR in Drug Discovery and Chemical Design—Some Examples | | 2015 |
International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences | AAPS Journal | 2015 |
Vancomycin Combined With Clindamycin for the Treatment of Acute Bacterial Skin and Skin-Structure Infections | Clinical Infectious Diseases | 2015 |
Overview of Oral Mucosal Delivery | Advances in Delivery Science and Technology | 2015 |
Advances in hormonal therapies for hormone naïve and castration-resistant prostate cancers with or without previous chemotherapy | Experimental Hematology and Oncology | 2015 |
Regulatory Requirements for PET Drug Production | Journal of Nuclear Medicine | 2014 |
In vitro dissolution of generic immediate-release solid oral dosage forms containing BCS class I drugs: comparative assessment of metronidazole, zidovudine, and amoxicillin versus relevant comparator pharmaceutical products in South Africa and India | AAPS PharmSciTech | 2014 |
Role of public standards in the safety and efficacy of biologic medicines | AAPS Journal | 2014 |
mTOR inhibitors and their role in modern concepts of immunosuppression | World Journal of Surgery | 2014 |
Intellectual Property Protection Strategies for Biotechnology Innovations | | 2014 |
Prevalence and Therapeutic Classifications of FDA-Approved Prescription Drugs With Boxed Warnings | Therapeutic Innovation and Regulatory Science | 2014 |
Regulatory Considerations in Development of Amorphous Solid Dispersions | Advances in Delivery Science and Technology | 2014 |
Adverse drug reaction prediction using scores produced by large-scale drug-protein target docking on high-performance computing machines | PLoS ONE | 2014 |
Patents associated with high-cost drugs in Australia | PLoS ONE | 2013 |
The future of USP monographs for PET drugs | Journal of Nuclear Medicine | 2013 |
Pharmaceutical salts: a summary on doses of salt formers from the Orange Book | European Journal of Pharmaceutical Sciences | 2013 |
Cost Effectiveness of Fracture Prevention in Postmenopausal Women Who Receive Aromatase Inhibitors for Early Breast Cancer | Breast Diseases | 2013 |
Mycophenolate fetal toxicity and risk evaluation and mitigation strategies | American Journal of Transplantation | 2013 |
A survey of top 200 drugs--inconsistent practice of drug strength expression for drugs containing salt forms | Journal of Pharmaceutical Sciences | 2012 |
Cost-effectiveness of long-term outpatient buprenorphine-naloxone treatment for opioid dependence in primary care | Journal of General Internal Medicine | 2012 |
QSAR classification of metabolic activation of chemicals into covalently reactive species | Molecular Diversity | 2012 |
Linkage of routinely collected oncology clinical data with health insurance claims data--an example with aromatase inhibitors, tamoxifen, and all-cause mortality | Pharmacoepidemiology and Drug Safety | 2012 |
Biomedical Text Mining: A Survey of Recent Progress | | 2012 |
Scientific and Regulatory Considerations for Development and Commercialization of Poorly Water-Soluble Drugs | AAPS Advances in the Pharmaceutical Sciences Series | 2012 |
Scientific considerations for complex drugs in light of established and emerging regulatory guidance | Annals of the New York Academy of Sciences | 2012 |
Generic drugs in dermatology: part I | Journal of the American Academy of Dermatology | 2012 |
Toward global standards for comparator pharmaceutical products: case studies of amoxicillin, metronidazole, and zidovudine in the Americas | AAPS Journal | 2012 |
Bioavailability and Bioequivalence | | 2012 |
ACCF/AHA 2011 health policy statement on therapeutic interchange and substitution: a report of the American College of Cardiology Foundation Clinical Quality Committee | Circulation | 2011 |
Mixed learning algorithms and features ensemble in hepatotoxicity prediction | Journal of Computer-Aided Molecular Design | 2011 |
Scientific considerations for generic synthetic salmon calcitonin nasal spray products | AAPS Journal | 2011 |
Computational systems chemical biology | Methods in Molecular Biology | 2011 |
History of Antipsychotic Drug Development | | 2011 |
Formulation patents and dermatology and obviousness | Pharmaceutics | 2011 |
Repositioned drugs: integrating intellectual property and regulatory strategies | Drug Discovery Today: Therapeutic Strategies | 2011 |
On firm ground: IP protection of therapeutic nanoparticles | Nature Biotechnology | 2010 |
Out-of-pocket prices of opioid analgesics in the United States, 1999-2004 | Pain Medicine | 2010 |
Biosimilar epoetins and other "follow-on" biologics: update on the European experiences | American Journal of Hematology | 2010 |
US pharmaceutical innovation in an international context | American Journal of Public Health | 2010 |