B. Bittner

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Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities

B. Bittner, W. Richter, Johannes Schmidt, 2018, BioDrugs.

Use of a Population Pharmacokinetic Approach for the Clinical Development of a Fixed-Dose Subcutaneous Formulation of Trastuzumab

M. Brewster, B. Lum, F. Hourcade‐Potelleret, 2014, CPT: pharmacometrics & systems pharmacology.

Connected drug delivery devices to complement drug treatments: potential to facilitate disease management in home setting

B. Bittner, Johannes Schmidt, S. Kharawala, 2019, Medical devices.

Oral Delivery of Therapeutic Proteins and Peptides: An Overview of Current Technologies and Recommendations for Bridging from Approved Intravenous or Subcutaneous Administration to Novel Oral Regimens

B. Bittner, M. Philippart, J. Schmidt, 2015, Drug Research.

Comparison of Subcutaneous and Intravenous Administration of Trastuzumab: A Phase I/Ib Trial in Healthy Male Volunteers and Patients With HER2‐Positive Breast Cancer

V. Harvey, C. Wynne, C. Schwabe, 2013, Journal of clinical pharmacology.

Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study.

F. Merli, A. Davies, N. Siritanaratkul, 2014, The Lancet. Oncology.

Pharmacokinetics and pharmacodynamics of single subcutaneous doses of tocilizumab administered with or without rHuPH20.

P. N. Morcos, Xiaoping Zhang, L. Rowell, 2013, International journal of clinical pharmacology and therapeutics.

Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study.

A. Salar, R. Bouabdallah, G. Follows, 2014, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Formulation and device lifecycle management of biotherapeutics—decision architecture

B. Bittner, Johannes Schmidt, 2022, Formulation and Device Lifecycle Management of Biotherapeutics.

Dispersive effects and focused biodistribution of recombinant human hyaluronidase PH20: A locally acting and transiently active permeation enhancer

B. Sugarman, B. Bittner, M. Printz, 2021, PloS one.

Enabling a flexible care setting in oncology—how to realize home- and self-administration of biotherapeutics in cancer care

B. Bittner, Johannes Schmidt, 2022, Formulation and Device Lifecycle Management of Biotherapeutics.

Formulation and device lifecycle management of biotherapeutics—leveraging synergies across therapeutic areas

B. Bittner, Johannes Schmidt, 2022, Formulation and Device Lifecycle Management of Biotherapeutics.

Comparison of Subcutaneous and Intravenous Administration of Trastuzumab: A Phase I/Ib Trial in Healthy Male Volunteers and Patients With HER2-Positive Breast Cancer.

V. Harvey, C. Wynne, C. Schwabe, 2013, Journal of clinical pharmacology.

Saquinavir 500 mg Film-Coated Tablets Demonstrate Bioequivalence to Saquinavir 200 mg Hard Capsules When Boosted with Twice-Daily Ritonavir in Healthy Volunteers

B. Holmes, B. Bittner, M. Riek, 2005, Antiviral therapy.

Study on the impact of SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) on the bioavailability of ibandronate (IBN) in postmenopausal women

M. Castelli, B. Bittner, C. McIntyre, 2011 .

Clinical development of subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies—pharmacokinetic-based bridging approach

B. Bittner, Johannes Schmidt, 2022, Formulation and Device Lifecycle Management of Biotherapeutics.

Enabling customer-centric and sustainable drug delivery— formulation and device lifecycle management of biotherapeutics

B. Bittner, Johannes Schmidt, 2022, Formulation and Device Lifecycle Management of Biotherapeutics.

Clinical development of automated subcutaneous injection devices—established pathways and novel concepts

B. Bittner, Johannes Schmidt, 2022, Formulation and Device Lifecycle Management of Biotherapeutics.

Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities

B. Bittner, W. Richter, Johannes Schmidt, 2018, BioDrugs.

Non-Clinical Pharmacokinetic/Pharmacodynamic and Early Clinical Studies Supporting Development of a Novel Subcutaneous Formulation for the Monoclonal Antibody Rituximab

F. Hourcade‐Potelleret, B. Bittner, W. Richter, 2014, Drug Research.

Development of a Subcutaneous Formulation for Trastuzumab – Nonclinical and Clinical Bridging Approach to the Approved Intravenous Dosing Regimen

F. Hourcade‐Potelleret, B. Bittner, W. Richter, 2012, Arzneimittelforschung/Drug Research.

In vitro investigation on the impact of the surface-active excipients Cremophor EL, Tween 80 and Solutol HS 15 on the metabolism of midazolam.

Jörg Huwyler, Isabelle Walter, J. Huwyler, 2004, Biopharmaceutics & drug disposition.

Potential inhibitory effects of formulation ingredients on intestinal cytochrome P450.

M. Schleimer, M Schleimer, I. Walter, 2000, International journal of pharmaceutics.

Drug-excipient interactions by Vitamin E-TPGS: in vitro studies on inhibition of P-glycoprotein and colonic drug absorption

M. Kuentz, B. Bohrmann, J. Huwyler, 2008 .

Intravenous administration of poorly soluble new drug entities in early drug discovery: the potential impact of formulation on pharmacokinetic parameters.

Beate Bittner, Richard J Mountfield, B. Bittner, 2002, Current opinion in drug discovery & development.

Customer-centric product presentations for monoclonal antibodies

B. Bittner, 2023, AAPS Open.

Phase I clinical study to select a novel oral formulation for ibandronate containing the excipient sodium N-[8-(2-hydroxybenzoyl) amino] caprylate (SNAC).

N. Fotaki, N. Shah, H. Chokshi, 2012, Die Pharmazie.

賦形剤N-[8-(2-ヒドロキシベンゾイル)アミノ]カプリル酸ナトリウム含有イバンドロナートについて新規経口製剤選択のための第I相臨床試験

N. Fotaki, N. Shah, H. Chokshi, 2012 .

Impact of solutol HS 15 on the pharmacokinetic behaviour of colchicine upon intravenous administration to male Wistar rats

J. Huwyler, I. Walter, B. Bittner, 2003, Biopharmaceutics & drug disposition.

Drug delivery improvements to enable a flexible care setting for monoclonal antibody medications in oncology - Analogue-based decision framework

B. Bittner, 2023, Expert opinion on drug delivery.

Drug-drug interaction study between a novel oral ibandronate formulation and metformin

P. Jordan, B. Bittner, Johannes Schmidt, 2011, Arzneimittelforschung.

A Two-Stage Phase Ib Study to Investigate the Pharmacokinetics, Safety and Tolerability of Subcutaneous Rituximab In Patients with Follicular Lymphoma as Part of Maintenance Treatment

A. Salar, R. Bouabdallah, P. Sayyed, 2010 .

Improved oral bioavailability of cyclosporin A in male Wistar rats. Comparison of a Solutol HS 15 containing self-dispersing formulation and a microsuspension.

J. Huwyler, I. Walter, B. Bittner, 2002, International journal of pharmaceutics.

Subcutaneous drug delivery devices—Enablers of a flexible care setting

B. Bittner, J. Schmidt, 2021 .

Improvement of the Bioavailability of Colchicine in Rats by Co-administration of D-α-Tocopherol Polyethylene Glycol 1000 Succinate and a Polyethoxylated Derivative of 12-Hydroxy-Stearic Acid

Alberto Guenzi, Beate Bittner, Pascal Fullhardt, 2002, Arzneimittelforschung.

Drug delivery breakthrough technologies - A perspective on clinical and societal impact.

Felix Schumacher, Simon Matoori, B. Bittner, 2023, Journal of controlled release : official journal of the Controlled Release Society.

Reply to: Letter to the editor “Subcutaneous herceptin therapy”

V. Harvey, C. Wynne, C. Schwabe, 2013, Journal of clinical pharmacology.

Preformulation Approaches to Improve the Oral Bioavailability of Two Novel Piperidine Renin Inhibitors in Dog

T. Lavé, M. Zell, M. Schleimer, 2002, Arzneimittelforschung.

In vitro investigation on the impact of Solutol HS 15 on the uptake of colchicine into rat hepatocytes.

F. Boess, B. Bittner, E. Durr, 2004, International journal of pharmaceutics.

Formulations and related activities for the oral administration of poorly water-soluble compounds in early discovery animal studies: An overview of frequently applied approaches. Part 1

B. Bittner, R. Mountfield, 2002 .

The impact of co-solvents and the composition of experimental formulations on the pump rate of the ALZET osmotic pump.

B. Bittner, R. Mountfield, T. Thelly, 2000, International journal of pharmaceutics.

Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access

B. Bittner, Johannes Schmidt, 2023, BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy.