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1

Biowaiver monographs for immediate release solid oral dosage forms: Levofloxacin

Marcelle O. Koeppe, Rodrigo Cristofoletti, Eduardo F. Fernandes, Silvia Storpirtis, Hans E. Junginger, Sabine Kopp, Kamal K. Midha, Vinod P. Shah, Salomon Stavchansky, Jennifer B. Dressman, Dirk M. Ba

Journal:

Journal of Pharmaceutical Sciences

Year:

2011

Language:

english

File:

PDF, 137 KB

english, 2011

2

Biowaiver monographs for immediate release solid oral dosage forms: Metronidazole

Camila F. Rediguieri, Valentina Porta, Diana S. G. Nunes, Taina M. Nunes, Hans E. Junginger, Sabine Kopp, Kamal K. Midha, Vinod P. Shah, Salomon Stavchansky, Jennifer B. Dressman, Dirk M. Barends

Journal:

Journal of Pharmaceutical Sciences

Year:

2011

Language:

english

File:

PDF, 141 KB

english, 2011

3

Rediguieri CF, Porta V, Nunes DSG, Nunes TM, Junginger HE, Kopp S, Midha KK, Shah VP, Stavchansky S, Dressman JB, Barends DM. 2011. Biowaiver monographs for immediate-release solid oral dosage forms: Metronidazole. J Pharm Sci 100:1618–1627.

Camila F. Rediguieri, Valentina Porta, Diana S. G. Nunes, Taina M. Nunes, Hans E. Junginger, Sabine Kopp, Kamal K. Midha, Vinod P. Shah, Salomon Stavchansky, Jennifer B. Dressman, Dirk M. Barends

Journal:

Journal of Pharmaceutical Sciences

Year:

2011

Language:

english

File:

PDF, 32 KB

english, 2011

4

Analytical methods validation: Bioavailability, bioequivalence, and pharmacokinetic studies

Vinod P. Shah, Kamal K. Midha, Shrikant Dighe, Iain J. McGilveray, Jerome P. Skelly, Avraham Yacobi, Thomas Layloff, C. T. Viswanathan, C. Edgar Cook, R. D. McDowall, Kenneth A. Pittman, Sidney Specto

Journal:

Journal of Pharmaceutical Sciences

Year:

1992

Language:

english

File:

PDF, 565 KB

english, 1992

5

Variation in the single dose pharmacokinetics of fluphenazine in psychiatric patients

Kamal K. Midha, Edward M. Hawes, John W. Hubbard, Elarien D. Korchinski, Gordon McKay

Journal:

Psychopharmacology

Year:

1988

Language:

english

File:

PDF, 553 KB

english, 1988

6

Fluphenazine plasma levels in patients receiving low and conventional doses of fluphenazine decanoate

Stephen R. Marder, Edward M. Hawes, Theodore Putten, John W. Hubbard, Gordon McKay, Jim Mintz, Philip R. A. May, Kamal K. Midha

Journal:

Psychopharmacology

Year:

1986

Language:

english

File:

PDF, 487 KB

english, 1986

7

Enantioselective pharmacokinetics and pharmacodynamics of dl-thero-mcthylphenidate in children with attention deficit hyperactivity disorder

Srinivas, Nuggehally R, Hubbard, John W, Quinn, Declan, Midha, Kamal K

Journal:

Clinical Pharmacology & Therapeutics

Year:

1992

Language:

english

File:

PDF, 1.09 MB

english, 1992

8

Methylphenidate Blood Levels and Therapeutic Response in Children with Attention-Deficit Hyperactivity Disorder I. Effects of Different Dosing Regimens

Teicher, Martin H., Polcari, Ann, Foley, Mary, Valente, Elizabeth, McGreenery, Cynthia E, Chang, Wei-Wei, McKay, Gordon, Midha, Kamal K

Journal:

Journal of Child and Adolescent Psychopharmacology

Year:

2006

Language:

english

File:

PDF, 345 KB

english, 2006

9

Radioimmunoassay for 7-Hydroxy Metabolite of Fluphenazine and its Application to Plasma Level Monitoring in Schizophrenic Patients Treated Long Term with Oral and Depot Fluphenazine

Aravagiri, Manickam, Marder, Stephen R., Putten, Theodore Van, Hawes, Edward M., McKay, Gord, Midha, Kamal K.

Journal:

Therapeutic Drug Monitoring

Year:

1994

File:

PDF, 690 KB

1994

10

In vitro identification of the human cytochrome p450 enzymes involved in the oxidative metabolism of loxapine

Jiang Ping Luo, Sarvesh C. Vashishtha, Edward M. Hawes, Gordon McKay, Kamal K. Midha, Jim Fang

Journal:

Biopharmaceutics & Drug Disposition

Year:

2011

Language:

english

File:

PDF, 220 KB

english, 2011

11

Piperazine ring cleavage in the electron impact induced fragmentation of piperazine type phenothiazine antipsychotic agents

H. Umesha Shetty, Edward M. Hawes, Kamal K. Midha

Journal:

Biological Mass Spectrometry = Journal of Mass Spectrometry (Wiley)

Year:

1983

Language:

english

File:

PDF, 503 KB

english, 1983

12

Enantiomeric drug development: Issues, considerations, and regulatory requirements

Nuggehally R. Srinivas, Rashmi H. Barbhaiya, Kamal K. Midha

Journal:

Journal of Pharmaceutical Sciences

Year:

2001

Language:

english

File:

PDF, 201 KB

english, 2001

13

Conference report: Bio-International 2005

Kamal K. Midha, Vinod P. Shah, Gur Jai Pal Singh, Rabi Patnaik

Journal:

Journal of Pharmaceutical Sciences

Year:

2007

Language:

english

File:

PDF, 116 KB

english, 2007

14

Transesterification using hydrogen bromide in diethyl ether–A means of identifying components of mixtures of fatty esters

R. T. Coutts, Kamal K. Midha

Journal:

Journal of Pharmaceutical Sciences

Year:

1969

Language:

english

File:

PDF, 369 KB

english, 1969

15

Synthesis and properties of some hypotensive N-alkylaminopropionic esters and N,N-dialkylaminopropionic esters and their hydroxamic acids

R. T. Coutts, J. W. Hubbard, Kamal K. Midha, K. Prasad

Journal:

Journal of Pharmaceutical Sciences

Year:

1971

Language:

english

File:

PDF, 564 KB

english, 1971

16

Synthesis of deuterium-labeled prochlorperazine

Edward M. Hawes, Trevor S. Gurnsey, H. Umesha Shetty, Kamal K. Midha

Journal:

Journal of Pharmaceutical Sciences

Year:

1983

Language:

english

File:

PDF, 248 KB

english, 1983

17

Chromatography and mass spectrometry in biomedical sciences 2. (analytical chemistry symposia series 14). Edited by A. Frigerio. Elsevier/North Holland, 52 Vanderbilt Avenue, New York, N.Y. 10017. 1983. 506 pp. 16 × 24 cm. Price $106.50 (Dfl. 250)

Journal:

Journal of Pharmaceutical Sciences

Year:

1983

Language:

english

File:

PDF, 157 KB

english, 1983

18

Synthesis of deuterium-labeled fluphenazine

H. Umesha Shetty, Edward M. Hawes, Kamal K. Midha

Journal:

Journal of Pharmaceutical Sciences

Year:

1984

Language:

english

File:

PDF, 550 KB

english, 1984

19

Radioimmunoassay for the 7-hydroxy metabolite of trifluoperazine and its application to a kinetic study in human volunteers

Manickam Aravagiri, Edward M. Hawes, Kamal K. Midha

Journal:

Journal of Pharmaceutical Sciences

Year:

1985

Language:

english

File:

PDF, 893 KB

english, 1985

20

Enantioselective aspects of the disposition of dl-threo-methylphenidate after the administration of a sustained-release formulation to children with attention deficit-hyperactivity disorder

John W. Hubbard, Nuggehally R. Srinivas, Declan Quinn, Kamal K. Midha

Journal:

Journal of Pharmaceutical Sciences

Year:

1989

Language:

english

File:

PDF, 420 KB

english, 1989

21

Consensus Report from “Bio International '89”: Issues in the Evaluation of Bioavailability Data

Iain J. McGilveray, Kamal K. Midha, Jerome P. Skelly, Shrikant Dighe, James T. Doluisio, Ian W. French, Aziz Karim, Robert Burford

Journal:

Journal of Pharmaceutical Sciences

Year:

1990

Language:

english

File:

PDF, 314 KB

english, 1990

22

Determination of risperidone in plasma by high-performance liquid chromatography with electrochemical detection: Application to therapeutic drug monitoring in schizophrenic patients

Manickam Aravagiri, Stephen R. Marder, Theodore van Putten, Kamal K. Midha

Journal:

Journal of Pharmaceutical Sciences

Year:

1993

Language:

english

File:

PDF, 356 KB

english, 1993

23

Development of a sensitive and specific radioimmunoassay for benztropine

Handan He, Gordon McKay, Kamal K. Midha

Journal:

Journal of Pharmaceutical Sciences

Year:

1993

Language:

english

File:

PDF, 741 KB

english, 1993

24

Bio-international 92, conference on bioavailability, bioequivalence, and pharmacokinetic studies

Henning H. Blume, Kamal K. Midha

Journal:

Journal of Pharmaceutical Sciences

Year:

1993

Language:

english

File:

PDF, 589 KB

english, 1993

25

Development and application of a specific and sensitive radioimmunoassay for trihexyphenidyl to a pharmacokinetic study in humans

Handan He, Gordon McKay, Bill Wirshing, Kamal K. Midha

Journal:

Journal of Pharmaceutical Sciences

Year:

1995

Language:

english

File:

PDF, 934 KB

english, 1995

26

Stereoselectivity in bioequivalence studies of nortriptyline

Kamal K. Midha, John W. Hubbard, Gordon McKay, Maureen Rawson, Roger Schwede

Journal:

Journal of Pharmaceutical Sciences

Year:

1995

Language:

english

File:

PDF, 255 KB

english, 1995

27

Separation of enantiomers of derivatised or underivatised propranolol by means of high-performance liquid chromatography

Madhu B. Grupta, John W. Hubbard, Kamal K. Midha

Journal:

Journal of Chromatography B: Biomedical Sciences and Applications

Year:

1988

Language:

english

File:

PDF, 430 KB

english, 1988

28

Enantioselective gas chromatographic assay with electron-capture detection for dl-ritalinic acid in plasma

Nuggehally R. Srinivas, John W. Hubbard, Kamal K. Midha

Journal:

Journal of Chromatography B: Biomedical Sciences and Applications

Year:

1990

Language:

english

File:

PDF, 585 KB

english, 1990

29

Isothermal capillary gas chromatography with electron-capture detection of heptafluorobutyryl-l-prolyl derivatives of chiral amphetamines

Nuggehally R. Srinivas, John K. Cooper, John W. Hubbard, Kamal K. Midha

Journal:

Journal of Chromatography B: Biomedical Sciences and Applications

Year:

1989

Language:

english

File:

PDF, 182 KB

english, 1989

30

Sensitive method for the simultaneous measurement of fluphenazine decanoate and fluphenazine in plasma by high-performance liquid chromatography with cuolometric detection

Jiang-Ping Luo, John W. Hubbard, Kamal K. Midha

Journal:

Journal of Chromatography B: Biomedical Sciences and Applications

Year:

1997

Language:

english

File:

PDF, 416 KB

english, 1997

31

Stereoselective and simultaneous measurement of cis- and trans-isomers of doxepin and N-desmethyldoxepin in plasma or urine by high-performance liquid chromatography

Jing-he Yan, John W. Hubbard, Gordon McKay, Kamal K. Midha

Journal:

Journal of Chromatography B: Biomedical Sciences and Applications

Year:

1997

Language:

english

File:

PDF, 556 KB

english, 1997

32

Erratum to “Identification of lactams as in vitro metabolites of piperidine-type phenothiazine antipsychotic drug” [J. Pharm. Biomed. Anal. 14 (1996) 727]

Ge Lin, Ka-Wing Chu, Lyaquatali A. Damani, Edward M. Hawes, Kamal K. Midha

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Year:

1997

Language:

english

File:

PDF, 34 KB

english, 1997

33

A pharmacokinetic study of trifluoperazine in two ethnic populations

Kamal K. Midha, Edward M. Hawes, John W. Hubbard, Elarien D. Korchinski, Gordon McKay

Journal:

Psychopharmacology

Year:

1988

Language:

english

File:

PDF, 643 KB

english, 1988

34

The sulfoxidation of fluphenazine in schizophrenic patients maintained on fluphenazine decanoate

Kamal K. Midha, John W. Hubbard, Stephen R. Marder, Edward M. Hawes, Theodore Putten, Gordon McKay, Phillip R. A. May

Journal:

Psychopharmacology

Year:

1987

Language:

english

File:

PDF, 551 KB

english, 1987

35

Pharmacokinetics of long-acting injectable neuroleptic drugs: clinical implications

Stephen R. Marder, John W. Hubbard, Theodore Putten, Kamal K. Midha

Journal:

Psychopharmacology

Year:

1989

Language:

english

File:

PDF, 937 KB

english, 1989

36

Generic products of antiepileptic drugs: A perspective on bioequivalence and interchangeability

Meir Bialer, Kamal K. Midha

Journal:

Year:

2010

Language:

english

File:

PDF, 193 KB

english, 2010

37

The impact of stereoisomerism in bioequivalence studies

Kamal K. Midha, Gordon McKay, Maureen J. Rawson, John W. Hubbard

Journal:

Journal of Pharmaceutical Sciences

Year:

1998

Language:

english

File:

PDF, 82 KB

english, 1998

38

Pharmacokinetics of fluphenazine, a highly lipophilic drug, estimated from a pulse dose of a stable isotopomer in dogs at steady state

John W. Hubbard, Salim Hadad, Jiang-Ping Luo, Gordon McKay, Kamal K. Midha

Journal:

Journal of Pharmaceutical Sciences

Year:

1999

Language:

english

File:

PDF, 59 KB

english, 1999

39

Metabolism of methoxyphenamine in extensive and poor metabolizers of debrisoquin

Roy, Samir D, Hawes, Edward M, McKay, Gordon, Korchinski, Elarien D, Midha, Kamal K

Journal:

Clinical Pharmacology & Therapeutics

Year:

1985

Language:

english

File:

PDF, 433 KB

english, 1985

40

Pharmaceutical sciences in 2020

Crommelin, Daan, Stolk, Pieter, Besançon, Luc, Shah, Vinod, Midha, Kamal, Leufkens, Hubert

Journal:

Nature Reviews Drug Discovery

Year:

2010

Language:

english

File:

PDF, 219 KB

english, 2010

41

Individual and average bioequivalence of highly variable drugs and drug products

Kamal K. Midha, Maureen J. Rawson, John W. Hubbard

Journal:

Journal of Pharmaceutical Sciences

Year:

1997

Language:

english

File:

PDF, 163 KB

english, 1997

42

Bioanalytical Method Validation—A Revisit with a Decade of Progress

Vinod P. Shah, Kamal K. Midha, John W. A. Findlay, Howard M. Hill, James D. Hulse, Iain J. McGilveray, Gordon McKay, Krys J. Miller, Rabindra N. Patnaik, Mark L. Powell, Alfred Tonelli, C.T. Viswanath

Journal:

Pharmaceutical Research

Year:

2000

Language:

english

File:

PDF, 92 KB

english, 2000

43

Evaluation of the Bioequivalence of Highly-Variable Drugs and Drug Products

Laszlo Tothfalusi, Laszlo Endrenyi, Kamal K. Midha, Maureen J. Rawson, John W. Hubbard

Journal:

Pharmaceutical Research

Year:

2001

Language:

english

File:

PDF, 129 KB

english, 2001

44

Individual Bioequivalence: Attractive in Principle, Difficult in Practice

Laszlo Endrenyi, Gordon L. Amidon, Kamal K. Midha, Jerome P. Skelly

Journal:

Pharmaceutical Research

Year:

1998

File:

PDF, 454 KB

1998

45

The Roles of Depot Injection Sites and Proximal Lymph Nodes in the Presystemic Absorption of Fluphenazine Decanoate and Fluphenazine: Ex Vivo Experiments in Rats

Jiang-ping Luo, John W. Hubbard, Kamal K. Midha

Journal:

Pharmaceutical Research

Year:

1998

File:

PDF, 407 KB

1998

46

Studies on the Mechanism of Absorption of Depot Neuroleptics: Fluphenazine Decanoate in Sesame oil

Jiang-Ping Luo, John W. Hubbard, Kamal K. Midha

Journal:

Pharmaceutical Research

Year:

1997

File:

PDF, 433 KB

1997

47

Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies

Vinod P. Shah, Kamal K. Midha, Shrikant Dighe, Iain J. McGilveray, Jerome P. Skelly, Avraham Yacobi, Thomas Layloff, C. T. Viswanathan, C. Edgar Cook, R. D. McDowall, Kenneth A. Pittman, Sidney Specto

Journal:

Pharmaceutical Research

Year:

1992

File:

PDF, 930 KB

1992

48

Use of Parent Drug and Metabolite Data in Bioavailability Assessment of a Novel Diltiazem HC1 Once-Daily Product

Okponanabofa Eradiri, Kamal K. Midha

Journal:

Pharmaceutical Research

Year:

1995

File:

PDF, 656 KB

1995

49

Evidence for the Lack of a Human Metabolic Isotope Effect of a Deuterium Analog of Fluphenazine

Salim Hadad, John W. Hubbard, Gordon McKay, Edward M. Hawes, Satishche Shrikhande, Kamal K. Midha

Journal:

Pharmaceutical Research

Year:

1995

File:

PDF, 349 KB

1995

50

Enantioselective Pharmacokinetics ofdl-threo-Methylphenidate in Humans

Nuggehally R. Srinivas, John W. Hubbard, Elarien D. Korchinski, Kamal K. Midha

Journal:

Pharmaceutical Research

Year:

1993

File:

PDF, 1.37 MB

1993