Kambayashi A, de Meijer M, Wegman K, van Veldhuizen C, Abrahamsson B, Cristofoletti R, Langguth P, Mehta M, Parr A, Polli JE, Shah VP, Dressman J. Biowaiver Monograph for Immediate-Release Dosage Forms: Levamisole Hydrochloride. J Pharm Sci. 2023 Mar;112(3):634-639. doi: 10.1016/j.xphs.2022.12.014. Epub 2022 Dec 21. PMID: 36563854.
Plano D, Rudolph N, Saal C, Abrahamsson B, Cristofoletti R, Kambayashi A, Langguth P, Mehta M, Parr A, Polli JE, Shah VP, Charoo N, Dressman J. Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Isavuconazonium Sulfate. J Pharm Sci. 2024 Feb;113(2):386-395. doi: 10.1016/j.xphs.2023.11.005. Epub 2023 Nov 10. PMID: 37951471.
Charoo NA, Abdallah DB, Bakheit AA, Haque KU, Hassan HA, Abrahamsson B, Cristofoletti R, Langguth P, Mehta M, Parr A, Polli JE, Shah VP, Tajiri T, Dressman J.
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate. J Pharm Sci. 2022 Jan;111(1):2-13. doi: 10.1016/j.xphs.2021.09.031.
Blumenstein I, Shanbhag S, Langguth P, Kalra PA, Zoller H, Lim W. Newer formulations of intravenous iron: a review of their chemistry and key safety aspects - hypersensitivity, hypophosphatemia, and cardiovascular safety. Expert Opin Drug Saf. 2021 Jul;20(7):757-769. doi: 10.1080/14740338.2021.1912010.
García MA, Cristofoletti R, Abrahamsson B, Groot DW, Parr A, Polli JE, Mehta M, Shah VP, Tomakazu T, Dressman JB, Langguth P. Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine. J Pharm Sci. 2021 May;110(5):1935-1947. doi: 10.1016/j.xphs.2021.02.019.
Metry M, Shu Y, Abrahamsson B, Cristofoletti R, Dressman JB, Groot DW, Parr A, Langguth P, Shah VP, Tajiri T, Mehta MU, Polli JE.
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Metformin Hydrochloride. J Pharm Sci. 2021 Apr;110(4):1513-1526. doi: 10.1016/j.xphs.2021.01.011.
Biggar P., Langguth P., Krayenbühl P.-A., Brandenburg V.: Intravenöse Eisensubstitution bei chronischer Erkrankung - bei wem, wann und wie. Dtsch. Med. Wochenschr. 2019; 144:969-977
Hofsäss MA, Souza J, Silva-Barcellos NM, Bellavinha KR, Abrahamsson B, Cristofoletti R, Groot DW, Parr A, Langguth P, Polli JE, Shah VP, Tajiri T, Mehta MU, Dressman JB. Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid. J Pharm Sci. 2017 Dec;106(12):3421-3430.
Rajawat GS, Belubbi T, Nagarsenker MS, Abrahamsson B, Cristofoletti R, Groot DW, Langguth P, Parr A, Polli JE, Mehta M, Shah VP, Tajiri T, Dressman J. Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Ondansetron. J Pharm Sci. (2019) pii: S0022-3549(19)30366-1. doi: 10.1016/j.xphs.2019.05.033.
Zane P, Gieschen H, Kersten E, Mathias N, Ollier C, Johansson P, Van den Bergh A, Van Hemelryck S, Reichel A, Rotgeri A, Schäfer K, Müllertz A, Langguth P. In vivo Models and Decision Trees for Formulation Development in Early Drug Development: A Review of Current Practices and Recommendations for Biopharmaceutical Development. Eur J Pharm Biopharm. 2019 Jun 21. pii: S0939-6411(17)31379-6. doi: 10.1016/j.ejpb.2019.06.010
I.E. Shohin, J.L. Kulinich, G.V. Ramenskaya, B. Abrahamsson, S. Kopp, P. Langguth, J.E. Polli, V.P. Shah, D.W. Groot, D.M. Barends, J.B. Dressman (2014): Biowaiver monographs for immediate release solid oral dosage forms: piroxicam. J Pharm Sci. 103: 366-377
N.A. Charoo, A.A. Shamsher, L.Y. Lian, B. Abrahamsson, R. Cristofoletti, D.W. Groot, S. Kopp, P. Langguth, J. Polli, V.P. Shah, J. Dressman (2014): Biowaiver monograph for immediate-release solid oral dosage forms: bisoprolol fumarate. J Pharm Sci. 2014 103: 378-391
A. Dahan, O. Wolk, M. Zur, G.L. Amidon, B. Abrahamsson, R. Cristofoletti, D.W. Groot, S. Kopp, P. Langguth, J.E. Polli, V.P. Shah, J.B. Dressman (2014): Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Codeine Phosphate. J Pharm Sci. 103: 1592-1600
R. Cristofoletti, A. Nair, B. Abrahamsson, D.W. Groot, S. Kopp, P. Langguth, J.E. Polli, V.P. Shah, J.B. Dressman (2013):
Biowaiver monographs for immediate-release solid oral dosage forms: Efavirenz. J. Pharm. Sci. 102: 318-329
E. Hühn, P. Langguth (2013):
In Vitro – In Vivo Correlations: General Principles and Methodologies, Regulatory Aspects and Applications. Pharm. Ind. 75: 143-152 (2013) Part 1 and 75: 312-318 (2013) Part 2
K.C. Soares, C.F. Rediguieri, J. Souza, C.H. Serra, B. Abrahamsson, D.W. Groot, S. Kopp, P. Langguth, J.E. Polli, V.P. Shah, J. Dressman (2013):
Biowaiver monographs for immediate-release solid oral dosage forms: Zidovudine (Azidothymidine). J. Pharm. Sci. 102: 2409-2423
S. Trebbien, P. Langguth, R. Neubert, F. Stieneker (2012):
Life-Cycle-Management von Arzneimitteln. Pharm. Ind. 74: 1-8
I.E. Shohin, J. Kulinich, G.V. Ramenskaya, B. Abrahamsson, S. Kopp, P. Langguth, J.E. Polli, V.P. Shah, D.W. Groot, D.M. BarendsJ.B. Dressman (2012):
Biowaiver monographs for immediate-release solid oral dosage forms: Ketoprofen. J. Pharm. Sci. 101: 3593-3603
J.B. Dressman, A. Nair, B. Abrahamsson, D.M. Barends, D.W. Groot, S. Kopp, P. Langguth, J.E. Polli, V.P. Shah, M. Zimmer (2012):
Biowaiver monographs for immediate-release solid oral dosage forms: Acetylsalicylic acid. J. Pharm. Sci. 101: 2653-2667
P. Langguth und J. Seydel (2011)
Glossar zu Begriffen der Pharmazeutik.
Angewandte Chemie 123: 3635 - 3651
K.S. Amidon, P. Langguth, H. Lennernäs, L. Yu, G.L. Amidon (2011) :
Bioequivalence (BE) of oral products and BCS: Science, regulation, and public policy. Clin. Pharmacol. Ther. 90: 467-470
T. Efferth, P. Langguth (2011):
Transport processes of radiopharmaceuticals and –modulators. Radiation oncology 6: 59
S. Grube, P. Langguth (2007):
Excipients as modulators of drug-carrier mediated absorption in the intestine. Drug Delivery Research Advances, Nova Science Publishers, NY
M. Jahn, S. Roth, P. Langguth (2006):
Parenterale kolloidale Eisenkomplexpräparate.
Deutsche Apotheker Zeitung, 146: 1510-1519
B. Beilmann, P. Langguth, H. Häusler, P. Grass (2006):
Pulverinhalatoren - biopharmazeutisch betrachtet
Deutsche Apotheker Zeitung, 147: 168-170
P. Langguth (2004):
Macrogol-15-hydroxystearat
Kommentar zum Deutschen Arzneibuch, Wissenschaftliche Verlagsgesellschaft Stuttgart
P. Langguth (2004):
Ammoniummethacrylat-Copolymer (Typ A)
Kommentar zur Ph.Eur. 4.07, Wissenschaftliche Verlagsgesellschaft Stuttgart
P. Langguth (2004):
Ammoniummethacrylat-Copolymer (Typ A)
Kommentar zur Ph.Eur. 4.07, Wissenschaftliche Verlagsgesellschaft Stuttgart
P. Langguth (2004):
Abrieb von Pellets und Granulaten
Kommentar zum Deutschen Arzneibuch, Wissenschaftliche Verlagsgesellschaft Stuttgart
P. Langguth (2004):
Basisches Butylmethacrylat Copolymer
Kommentar zur Ph.Eur. 4.04, Wissenschaftliche Verlagsgesellschaft Stuttgart
P. Marroum, H. Spahn-Langguth, P. Langguth (2004):
Metabolism, transport and drug interactions. In Sahajwalia C.: New Drug Application: Regulatory and Scientific Principles for Clinical Pharmacology and Biopharmaceutics. Drugs and the Pharmaceutical Sciences Series Vol. 141, Marcel Dekker, 2004.
P. Langguth (2004):
FIP-Kongreß der Pharmazeutischen Wissenschaften.
Pharm. Ind. 66, 1133-1136
P. Langguth, K. Lövgren, H. Blume, U. Kleeberg, H. Kleinsorge (1999):
Pharmazeutische Qualität von Omeprazol-Fertigarzneimitteln.
Klinikarzt 8, 225-228
P. Langguth (1999):
Pharmakokinetik
In: J. Kreuter, K.D. Herzfeld (Eds.) Grundlagen der Arzneiformenlehre, Galenik 2, Springer Verlag, 450-509
P. Langguth, G.L. Amidon, E. Lipka, H. Spahn-Langguth (1997):
Gastrointestinal transport processes: Potentials for stereoselectivities at substrate-specific and -nonspecific epithelial transport systems.
The impact of drug stereochemistry on clinical development and use. I. Wainer, H. Aboul-Enein (Eds.), J. Wiley & Sons, New York, 611-632
H. Spahn-Langguth, W. Möhrke, L.Z. Benet, P. Langguth (1997):
First-pass phenomena: Sources of stereoselectivities and variabilities in concentration-time profiles after p.o. dosage.
The impact of drug stereochemistry on clinical development and use. I. Wainer, H. Aboul-Enein (Eds.), J. Wiley & Sons, New York, 573-610
H. Spahn-Langguth, P. Langguth, L.Z. Benet (1997):
Kinetics of reactive phase II metabolites: Stereochemical aspects of formation of epimeric acyl glucuronides and their reactivity.
The impact of drug stereochemistry on clinical development and use. I. Wainer, H. Aboul-Enein (Eds.), J. Wiley & Sons, New York, 125-170
R. Büschges, H. Aboul-Enein, E. Martin, P. Langguth, H. Spahn-Langguth (1997):
Chiral derivatization reagents in the bioanalysis of optically active drugs with chromophor based detection.
The impact of drug stereochemistry on clinical development and use. I. Wainer, H. Aboul-Enein (Eds.), J. Wiley & Sons, New York
P. Langguth, V. Bohner, H.P. Merkle, J. Biber (1993):
Bürstensaummembranvesikel zur Untersuchung der intestinalen Absorption und des Metabolismus von Arzneistoffen.
Deutsche Apotheker Zeitung, 133, 4766-4770
H. Spahn-Langguth, P. Langguth, D. Brockmeier (1993):
The Pharmacokinetics of Piretanide in Humans: An Update. In: S. Johnson, F.N. Johnson, E. Mutschler, H. Knauf (Eds.): Piretanide, Marius Press, Lancashire, UK, 11-29
P. Langguth, I. Steinsträsser, K.H. Müller (1991):
Die Haut; Biopharmazeutische Grundlagen.
Pharmactuel 8, 1-24
E. Mutschler, P. Langguth (1987):
Transdermale Therapeutische Systeme.
Fortschr. Med. 29, 571-574
E. Mutschler, P. Langguth (1985):
Pharmacodynamics and the need for rate-controlled drug delivery.
Topics in Pharmaceutical Sciences, Proceedings of the 45th Int. Congress of Pharmaceutical Sciences of FIP in Montreal, ed. by D.D. Breimer, P. Speiser, Elsevier, Amsterdam, 103-117