Ocular Bioanalysis: Challenges and Advancements in Recent Years for These Rare Matrices

References

• World Health Organization . www.who.int/mediacentre/factsheets/fs282/en/.
   Google Scholar
• Caras IW , LittmanN, AboA. Proceedings: debilitating eye diseases. Stem Cells Transl. Med. 3 (12), 1393–1397 (2014).
   PubMed Web of Science ®Google Scholar
• Fraier D . Drugs in Ocular Fluids/Tissue: why so many challenges in method development & validation? What are the current solutions? Presented at : 11th Workshop on Recent Issues in Bioanalysis. LA, USA, 3–7 April 2017.
   Google Scholar
• Gower NJD , BarryRJ, EdmundsMR, TitcombLC, DennistonAK. Drug discovery in ophthalmology: past success, present challenges, and future opportunities. BMC Ophthalmol. 16, 1–11 (2016).
   PubMed Web of Science ®Google Scholar
• Macwan JS , HiraniA, PathakY. Challenges in ocular pharmacokinetics and drug delivery. In : Nano-Biomaterials for Ophthalmic Drug Delivery. PathakY, SutariyaV, HiraniA ( Eds). Springer, Cham, Switzerland (2016).
   Google Scholar
• Glaucoma Research Foundation . www.glaucoma.org.
   Google Scholar
• Lovett ML , WangX, YucelTet al. Silk hydrogels for sustained ocular delivery of anti-vascular endothelial growth factor (anti-VEGF) therapeutics. Eur. J. Pharm. Biopharm. 95 (Part B), 271–278 (2015).
   PubMedGoogle Scholar
• Hsu K-H , GauseS, ChauhanA. Review of ophthalmic drug delivery by contact lenses. J. Drug Deliv. Sci. Technol. 24 (2), 123–135 (2014).
   Web of Science ®Google Scholar
• Chennamaneni SR , MamalisC, ArcherB, OakeyZ, AmbatiBK. Development of a novel bioerodible dexamethasone implant for uveitis and postoperative cataract inflam. J. Control. Release167, 53–59 (2013).
   PubMed Web of Science ®Google Scholar
• Mehta P , Haj-AhmadR, Al-KinaniAet al. Approaches in topical ocular drug delivery and developments in the use of contact lenses as drug-delivery devices. Ther. Deliv. 8 (7), 521–541 (2017).
   PubMed Web of Science ®Google Scholar
• Kang-Mieler JJ , DosmarE, LiuW, MielerWF. Extended ocular drug delivery systems for the anterior and posterior segments: biomaterial options and applications. Expert Opin. Drug Deliv. 14 (5), 611–620 (2017).
   PubMed Web of Science ®Google Scholar
• Mandal A , BishtR, RupenthalID, MitraAK. Polymeric micelles for ocular drug delivery: from structural frameworks to recent preclinical studies. J. Control. Release248, 96–116 (2017).
   PubMed Web of Science ®Google Scholar
• Singh RRT , TekkoI, McAvoyKet al. Minimally invasive microneedles for ocular drug delivery. Expert Opin. Drug Deliv. 14 (4), 525–537 (2017).
   PubMed Web of Science ®Google Scholar
• Yavuz B , PehlivanSB, KaffashiA. In vivo tissue distribution and efficacy studies for cyclosporin A loaded nano-decorated subconjunctival implants. Drug Deliv. 23 (9), 3279–3284 (2016).
   PubMed Web of Science ®Google Scholar
• Chennamaneni SR , MamalisC, ArcherB, OakeyZ, AmbatiBK. Development of a novel bioerodible dexamethasone implant for uveitis and postoperative cataract inflammation. J. Control. Release167 (1), 53–59 (2013).
   PubMed Web of Science ®Google Scholar
• Araki-Sasaki K , KatsutaO, ManoH, NaganoT, NakamuraM. The effects of oral and topical corticosteroid in rabbit corneas. BMC Ophthalmology16 (160), 1–6 (2016).
   PubMedGoogle Scholar
• Huang X , PengM, YangYet al. Dexamethasone distribution characteristic following controllable continuous sub-tenon drug delivery in rabbit. Drug Deliv. 24 (1), 818–824 (2017).
   PubMed Web of Science ®Google Scholar
• Boddu SHS , GuptaH, BonamSP. Preclinical evaluation of a ricinoleic acid poloxamer gel system for transdermal eyelid delivery. Int. J. Pharm. 470 (1–2), 158–161 (2014).
   PubMedGoogle Scholar
• Eichenbaum G , ZhouJ, KelleyMFet al. Implications of retinal effects observed in chronic toxicity studies on the clinical development of a CNS-active drug candidate. Regul. Toxicol. Pharmacol. 69 (2), 187–200 (2014).
   PubMed Web of Science ®Google Scholar
• Farkouh A , FrigoP, CzejkaM. Systemic side effects of eye drops: a pharmacokinetic perspective. Clin. Ophthalmol. 10, 2433–2441 (2016).
   PubMed Web of Science ®Google Scholar
• Velagaleti PR , BuonaratiMH. Challenges and strategies in drug residue measurement (bioanalysis) of ocular tissues. In : Ocular Pharmacology and Toxicology. Methods in Pharmacology and Toxicology. GilgerB ( Ed). Humana Press, Totowa, NJ (2014).
   Google Scholar
• Ho S . Tissue analysis and tissue imaging. In : Eliminating Bottlenecks for Efficient Bioanalysis: Practices and Applications in Drug Discovery and Development. ShouWZ, WengN ( Eds). Future Science Group, London, UK (2014).
   Google Scholar
• McEwen AB , HensonCM, WoodSG. Quantitative whole-body autoradiography, LC–MS/MS and MALDI for drug-distribution studies in biological samples: the ultimate matrix trilogy. Bioanalysis6 (3), 377–391 (2014).
   PubMed Web of Science ®Google Scholar
• Xue Y-J , GaoH, JiQCet al. Bioanalysis of drug in tissue: current status and challenges. Bioanalysis4 (21), 2637–2653 (2012).
   PubMed Web of Science ®Google Scholar
• Kemper CJ , KoetznerL, KoletoM. A primer for best practices in tissue preparation for bioanalysis. Bioanalysis4 (21), 2621–2636 (2012).
   PubMed Web of Science ®Google Scholar
• Smith KM , XuY. Tissue sample preparation in bioanalytical assays. Bioanalysis4 (6), 741–749 (2012).
   PubMed Web of Science ®Google Scholar
• Tsefrikas V , ZhangX. Analysis of small molecule drugs in tissue: current practices. In : Tissue Analysis for Drug Development. HoS ( Ed.). Future Science Group, London, UK (2013).
   Google Scholar
• Bertran E . Challenges in ocular bioanalysis. Presented at : 9th European Bioanalysis Forum Open Meeting. Barcelona, Spain, 16–18 November 2016.
   Google Scholar
• Hantash J . Method Development and Validation of Biologics and Small Molecules in Ocular Tissues – Focusing on Bioanalytical Challenges and Foreseeing Regulatory Concerns. Presented at : 9th European Bioanalysis Forum Open Meeting, Barcelona, Spain, 6–18 November 2016.
   Google Scholar
• Heinig K , DzygielP, BucheliFet al. Challenges in ocular bioanalysis. 8th European Bioanalysis Forum Open Meeting, Barcelona, Spain, 18–20 November 2015.
   Google Scholar
• Tsefrikas V , BennettD, GoodsellKet al. Analysis of ocular tissues: investigation of potential matrix effects. Presented at : The Land O’Lakes Bioanalytical Conference. Merrimac, WI, USA, 15–18 July 2012.
   Google Scholar
• Glogowski S , LoweE, Siou-MermetR, OngT, RichardsonM. Prolonged exposure to loteprednol etabonate in human tear fluid and rabbit ocular tissues following topical ocular administration of lotemax gel, 0.5%. J. Ocul. Pharmacol. Ther. 30 (1), 66–73 (2014).
   PubMed Web of Science ®Google Scholar
• Arnold DR , GranvilCP, WardKW, ProkschJW. Quantitative determination of besifloxacin, a novel fluoroquinolone antimicrobial agent, in human tears by liquid chromatography–tandem mass spectrometry. J. Chromatogr. B867 (1), 105–110 (2008).
   PubMed Web of Science ®Google Scholar
• Hirosawa M , SambeT, UchidaN, LeeX-P, SatoK, ShinichiKobayashi. Determination of nonsteroidal anti-inflammatory drugs in human tear and plasma samples using ultra-fast liquid chromatography-tandem mass spectrometry. Jpn. J. Ophthalmol. 59 (5), 364–371 (2015).
   PubMed Web of Science ®Google Scholar
• Takamura Y , TomomatsuT, MatsumuraTet al. Vitreous and aqueous concentrations of brimonidine following topical application of brimonidine tartrate 0.1% ophthalmic solution in humans. J. Ocul. Pharmacol. Ther. 31 (5), 282–285 (2015).
   PubMed Web of Science ®Google Scholar
• Bucci Jr FA , NguimfackIT, FluetAT. Pharmacokinetics and aqueous humor penetration of levofloxacin 1.5% and moxifloxacin 0.5% in patients undergoing cataract surgery. Clin. Ophthalmol. 10, 783–789 (2016).
   PubMedGoogle Scholar
• Wang S , WangZ, YangSet al. Tissue distribution of trans-resveratrol and its metabolites after oral administration in human eyes. J. Ophthalmol. 2017, 4052094 (2017).
   PubMed Web of Science ®Google Scholar
• Ichhpujani P , KatzLJ, HolloGet al. Comparison of human ocular distribution of bimatoprost and latanoprost. J. Ocul. Pharmacol. Ther. 28 (2), 134–145 (2012).
   PubMed Web of Science ®Google Scholar
• Glogowski S , WardKW, LawrenceMSet al. The ise of the African green monkey as a preclinical model for ocular pharmacokinetic studies. J. Ocul. Pharmacol. Ther. 28 (3), 290–298 (2012).
   PubMed Web of Science ®Google Scholar
• Domingos LC , MoreiraMVL, KellerKMet al. Simultaneous quantification of gatifloxacin, moxifloxacin, and besifloxacin concentrations in cornea and aqueous humor by LC-QTOF/MS after topical ocular dosing. J. Pharm. Toxicol. Meth. 83, 87–93 (2017).
   PubMed Web of Science ®Google Scholar
• Khatal L , GaurA, NaphadeA, KandikereV, MookhtiarK. Impact of APCI ionization source in liquid chromatography tandem mass spectrometry based tissue distribution studies. Biomed. Chromatogr. 30, 1676–1685 (2016).
   PubMedGoogle Scholar
• He H , Williams-GuyK, PagadalaJet al. A sensitive and fast LC–MS/MS method for determination of β-receptor agonist JP-49b: application to a pharmacokinetic study in rats. J. Chromatogr. B15 (0), 86–91 (2014).
   Google Scholar
• Martins Duarte Byrro R , de Oliveira FulgêncioG, Rocha ChelliniP, da Silva CunhaAJr, PianettiGA. Determination of Mycophenolic acid in the vitreous humor using the HPLC–ESI-MS/MS method: application of intraocular pharmacokinetics study in rabbit eyes with ophthalmic implantable device. J. Pharm. Biomed. Anal. 84, 30–35 (2013).
   PubMed Web of Science ®Google Scholar
• Liu B , DingL, XuXet al. Ocular and systemic pharmacokinetics of lidocaine hydrochloride ophthalmic gel in rabbits after topical ocular administration. Eur. J. Drug Metab. Pharmacokinet. 40 (4), 409–415 (2015).
   PubMed Web of Science ®Google Scholar
• Latreille PL , BanquyX. A simple method for the subnanomolar quantitation of seven ophthalmic drugs in the rabbit eye. Anal. Bioanal. Chem. 407, 3567–3578 (2015).
   PubMed Web of Science ®Google Scholar
• Woodward DF , WenthurSL, RudebushTL, FanS, TorisCB. Prostanoid receptor antagonist effects on intraocular pressure, supported by ocular biodisposition experiments. J. Ocul. Pharmacol. Ther. 32 (9), 606–622 (2016).
   PubMed Web of Science ®Google Scholar
• Iyer GR , CasonMM, WombleSWet al. Ocular pharmacokinetics comparison between 0.2% olopatadine and 0.77% olopatadine hydrochloride ophthalmic solutions administered to male New Zealand white rabbits. J. Ocul. Pharmacol. Ther. 31 (4), 204–210 (2015).
   PubMed Web of Science ®Google Scholar
• Earla R , CholkarK, GundaS, EarlaRL, MitraAK. Bioanalytical method validation of rapamycin in ocular matrix by QTRAP LC–MS/MS: application to rabbit anterior tissue distribution by topical administration of rapamycin nanomicellar formulation. J. Chromatogr. B908, 76–86 (2012).
   PubMed Web of Science ®Google Scholar
• Earla R , BodduHS, CholkarK, HariharanSet al. Development and validation of a fast and sensitive bioanalytical method for the quantitative determination of glucocorticoids – quantitative measurement of dexamethasone in rabbit ocular matrices by liquid chromatography tandem mass spectrometry. J. Pharm. Biomed. Anal. 52, 525–33 (2010).
   PubMed Web of Science ®Google Scholar
• Junli L , JingjingS, YandongWet al. Ocular pharmacokinetics of naringenin eye drops following topical administration to rabbits. J. Ocul. Pharmacol. Ther. 31 (1), 51–56 (2015).
   PubMed Web of Science ®Google Scholar
• Mao Z , WangX, LiuY. Simultaneous determination of seven alkaloids from Rhizoma Corydalis Decumbentis in rabbit aqueous humor by LC–MS/MS: application to ocular pharmacokinetic studies. J. Chromatogr. B1057, 46–53 (2017).
   PubMed Web of Science ®Google Scholar
• Gu X-F , MaoB-Y, XiaMet al. Rapid, sensitive and selective HPLC–MS/MS method for the quantification of topically applied besifloxacin in rabbit plasma and ocular tissues: application to a pharmacokinetic study. J. Pharm. Biomed. Anal. 117 (5), 37–46 (2016).
   PubMedGoogle Scholar
• Djebli N , KhierS, GriguerFet al. Ocular drug distribution after topical administration: population pharmacokinetic model in rabbits. Eur. J. Drug Metab. Pharmacokinet. 42, 59–68 (2017).
   PubMed Web of Science ®Google Scholar
• Cholkar K , GilgerBC, MitraAK. Topical, aqueous, clear cyclosporine formulation design for anterior and posterior ocular delivery. Trans Vis Sci Tech4 (3), 1–16 (2015).
   PubMed Web of Science ®Google Scholar
• Kim J , KudischM, MudumbaSet al. Biocompatibility and pharmacokinetic analysis of an intracameral polycaprolactone <i>drug delivery</i> implant for glaucoma. Invest. Ophthalmol. Vis. Sci. 57, 4341–4346 (2016).
   PubMed Web of Science ®Google Scholar
• Schwab D , SturmC, PortronAet al. Oral administration of the 11bhydroxysteroid- dehydrogenase type 1 inhibitor RO5093151 to patients with glaucoma: an adaptive, randomised, placebo-controlled clinical study. BMJ Open Ophthalmol. 1, e000063 (2017).
   PubMedGoogle Scholar
• Verhoeven RS , GarciaA, RobesonRet al. Nonclinical development of ENV905 (difluprednate) ophthalmic implant for the treatment of inflammation and pain associated with ocular surgery. J. Ocul. Pharmacol. Ther. doi: 10.1089/jop.2016.0195 (2017) ( Epub ahead of print).
   PubMed Web of Science ®Google Scholar
• Guohua Wang , QixiaNie, ChenZang. Self-Assembled Thermoresponsive Nanogels Prepared by Reverse Micelle Positive Micelle Method for Ophthalmic Delivery of Muscone, a Poorly Water-Soluble Drug. J. Pharm. Sci. 105 (9), 2752–2759 (2016).
   PubMed Web of Science ®Google Scholar
• Chastain JE , SandersME, CurtisMA. Distribution of topical ocular nepafenac and its active metabolite amfenac to the posterior segment of the eye. Exp. Eye Res. 145, 58–67 (2016).
   PubMed Web of Science ®Google Scholar
• Kane FE , GreenKE. Ocular pharmacokinetics of fluocinolone acetonide following iluvien implantation in the vitreous humor of rabbits. J. Ocul. Pharmacol. Ther. 31 (1), 11–16 (2015).
   PubMed Web of Science ®Google Scholar
• Bisht R , MandalA, RupenthalID, MitraAK. Ex vivo investigation of ocular tissue distribution following intravitreal administration of connexin43 mimetic peptide using the microdialysis technique and LC–MS/MS. Drug Deliv. Transl. Res. 6, 763–770 (2016).
   PubMed Web of Science ®Google Scholar
• Faqi AS . A Comprehensive Guide to Toxicology in Preclinical Drug Development. Academic Press, MA, USA (2013).
   Google Scholar
• Struble C , HowardS, RelphJ. Comparison of ocular tissue weights (volumes) and tissue collection techniques in commonly used preclinical animal species. Acta Ophthalmol. 92 (s253), 0 (2014).
   Google Scholar
• Agrahari V , MandalA, AgrahariVet al. A comprehensive insight on ocular pharmacokinetics. Drug Deliv. Transl. Res. 6, 735–754 (2016).
   PubMed Web of Science ®Google Scholar
• Bode G , ClausingP, GervaisFet al. The utility of the minipig as an animal model in regulatory toxicology. J. Pharmacol. Toxicol. Methods62 (3), 196–220 (2010).
   PubMed Web of Science ®Google Scholar
• Cholkar K , GilgerBC, MitraAK. Topical delivery of aqueous micellar resolvin E1 analog (RX-10045). Int. J. Pharm. 498, 326–334 (2016).
   PubMed Web of Science ®Google Scholar
• Capiau S , AlffenaarJW, StoveCP. Alternative sampling strategies for therapeutic drug monitoring. In : Clinical Challenges in Therapeutic Drug Monitoring: Special Populations, Physiological Conditions and Pharmacogenomics. ClarkeW, DasguptaA ( Eds). Elsevier, Amsterdam, The Netherlands (2016).
   Google Scholar
• Chandasana H . Challenges associated with the quantification of tear fluids. J. Bioequiv. Availab. 8 (6), e73 (2016).
   Google Scholar
• Raju KSR , TanejaI, SinghSP, Wahajuddin. Utility of noninvasive biomatrices in pharmacokinetic studies. Biomed. Chromatogr. 27, 1354–1366 (2013).
   PubMed Web of Science ®Google Scholar
• Posa A , BräuerL, SchichtMet al. Schirmer strip vs. capillary tube method: non-invasive methods of obtaining proteins from tear fluid. Ann. Anat. 195, 137–142 (2013).
   PubMed Web of Science ®Google Scholar
• Li F , EwlesM, PelzerMet al. Case studies: the impact of nonanalyte components on LC–MS/MS-based bioanalysis: strategies for identifying and overcoming matrix effects. Bioanalysis5 (19), 2409–2441 (2013).
   PubMed Web of Science ®Google Scholar
• Qin AR , LiangX, DengY, DeanB, Shahidi-LathamSK. Collagenase as an effective tool for drug quantitation in tissues. Bioanalysis7 (9), 1069–1079 (2015).
   PubMed Web of Science ®Google Scholar
• Unger S , HorvathT, TanMet al. Making methods rugged for regulated bioanalysis. Bioanalysis7 (7), 833–852 (2015).
   PubMed Web of Science ®Google Scholar
• Hilhorst M , van AmsterdamP, HeinigK, ZwanzigerE, AbbottR. Stabilization of clinical samples collected for quantitative bioanalysis – a reflection from the European Bioanalysis Forum. Bioanalysis7 (3), 333–343 (2015).
   PubMed Web of Science ®Google Scholar
• Rocci ML , LowesS (Eds). Regulated Bioanalysis: Fundamentals and Practice. Springer, Berlin, Germany (2017).
   Google Scholar
• Li W , ZhangJ, TseFLS. Handbook of LC–MS Bioanalysis: Best Practices, Experimental Protocols, and Regulations. John Wiley & Sons, NJ, USA (2013).
   Google Scholar
• Reimer MT , WanX, ZhangJ. A case study of validation and sample analysis for the determination of zotarolimus in various tissues. Bioanalysis5 (7), 811–817 (2013).
   PubMed Web of Science ®Google Scholar
• Ocque AJ , HaglerCE, DifrancescoRet al. Development and validation of a UPLC–MS/MS method for the simultaneous determination of paritaprevir and ritonavir in rat liver. Bioanalysis8 (13), 1353–1363 (2016).
   PubMed Web of Science ®Google Scholar
• van de Merbel N , SavoieN, YadavMet al. Stability: recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team. AAPS J16 (3), 392–399 (2014).
   PubMed Web of Science ®Google Scholar
• Tan A , FanarasJC. Nonspecific binding in LC–MS bioanalysis. In:WengN, JianW (Eds). Targeted Biomarker Quantitation by LC–MS. John Wiley & Sons, NJ, USA (2017).
   Google Scholar
• Kim H-J , KangJ-S. Matrix effects: Hurdle for development and validation of bioanalytical LC–MS methods in biological samples analyses. Biodesign4 (2), 46–58 (2016).
   Google Scholar
• Bartlett MG , HooshfarS. Hazards in chromatographic bioanalysis method development and applications. Biomed. Chromatogr. 31, 1–10 (2017).
   Web of Science ®Google Scholar
• Burden N , ChapmanK, SewellF, RobinsonV. Pioneering better science through the 3Rs: an introduction to the National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs). J. Am. Assoc. Lab. Anim. Sci. 54 (2), 198–208 (2015).
   PubMed Web of Science ®Google Scholar
• Festing S , WilkinsonR. The ethics of animal research. In : The Animal Ethics Reader. ArmstrongSJ, BotzlerRG ( Eds). Taylor & Francis, London, UK (2016).
   Google Scholar
• Gill Fleetwood , MagdaChlebus, JoachimCoenenet al. Making progress and gaining momentum in global 3Rs efforts: how the European Pharmaceutical Industry is contributing. J. Am. Assoc. Lab. Anim. Sci. 54 (2), 192–197 (2015).
   PubMed Web of Science ®Google Scholar
• Waxenecker G , BinderR. Regulatory animal testing for the development of medicines. In : Comparative Medicine. Jensen-JarolimE ( Eds). Springer, Cham (2017).
   Google Scholar
• Ho S , GaoH. Surrogate matrix: opportunities and challenges for tissue sample analysis. Bioanalysis7 (18), 2419–2433 (2015).
   PubMed Web of Science ®Google Scholar
• Macri A , MariniV, SangalliG, FucileC, IesterM, MattioliF. An artificial aqueous humor as a standard matrix to assess drug concentration in the anterior chamber by high performance liquid chromatography methods. Clin. Lab. 61 (1–2), 47–52 (2015).
   PubMed Web of Science ®Google Scholar
• Timmerman P , WhiteS, McDougallSet al. Tiered approach into practice: scientific validation for chromatography-based assays in early development – a recommendation from the European Bioanalysis Forum. Bioanalysis7 (18), 2387–2398 (2015).
   PubMed Web of Science ®Google Scholar
• Reilly J , WilliamsSL, ForsterCJet al. High-throughput melanin-binding affinity and in silico methods to aid in the prediction of drug exposure in ocular tissue. J. Pharm. Sci. 104, 3997–4001 (2015).
   PubMed Web of Science ®Google Scholar
• Durairaj C . Ocular pharmacokinetics in pharmacologic therapy of ocular disease. In : Handbook of Experimental Pharmacology. WhitcupS, AzarD ( Eds). Springer, Heidelberg, Germany (2016).
   Google Scholar
• You L , QianJ, WuXet al. Propagation of error in ocular pharmacokinetic parameters estimate of azithromycin in rabbits. J. Pharm. Sci. 102 (7), 2371–2379 (2013).
   PubMed Web of Science ®Google Scholar
• del Amo EM , UrttiA. Rabbit as an animal model for intravitreal pharmacokinetics: clinical predictability and quality of the published data. Exp. Eye Res. 137, 111–124 (2015).
   PubMed Web of Science ®Google Scholar
• Argikar UA , DumouchelJL, KramlingerVM. Do we need to study metabolism and distribution in the eye: why, when, and are we there yet?J. Pharm. Sci. 106 (9), 2276–2281 (2017).
   PubMed Web of Science ®Google Scholar
• Pamulapati CR , SchoenwaldRD. Ocular pharmacokinetics of a novel tetrahydroquinoline analog in rabbit: compartmental analysis and PK-PD evaluation. J. Pharm. Sci. 101 (1), 414–423 (2012).
   PubMed Web of Science ®Google Scholar
• Tuntland T , EthellB, KosakaTet al. Implementation of pharmacokinetic and pharmacodynamic strategies in early research phases of drug discovery and development at Novartis Institute of Biomedical Research. Front. Pharmacol. 5 (174), 1–16 (2014).
   PubMedGoogle Scholar
• Driscoll A , BlizzardC. Toxicity and pharmacokinetics of sustained-release dexamethasone in beagle dogs. Adv. Ther. 33, 58–67 (2016).
   PubMed Web of Science ®Google Scholar
• Maulvi FA , LakdawalaDH, ShaikAAet al. In vitro and in vivo evaluation of novel implantation technology in hydrogel contact lenses for controlled drug delivery. J. Control. Release226, 47–56 (2016).
   PubMed Web of Science ®Google Scholar
• Guidance for Industry Bioanalytical Method Validation . US Department of Health and Human Services, US FDA, MD, USA (2001). www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf.
   Google Scholar
• Guideline on Bioanalytical Method Validation . European Medicines Agency, London, UK (2011). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.
   Google Scholar
• Timmerman P , MokrzyckiN, DelratPet al. Recommendations from the European Bioanalysis Forum on method establishment for tissue homogenates. Bioanalysis6 (12), 1647–1656 (2014).
   PubMed Web of Science ®Google Scholar
• Abbott RW . Tiered approach: sense and sensibility. Bioanalysis6 (5), 611–616 (2014).
   PubMed Web of Science ®Google Scholar
• Timmermann P . Tiered approach revisited: introducing stage-appropriate or assay-appropriate scientific validation. Bioanalysis6 (5), 599–604 (2014).
   PubMed Web of Science ®Google Scholar
• Weng N . Current regulatory guidance pertaining biomarker assay establishment and industrial practice of fit-for-purpose and tiered approach. In : Targeted Biomarker Quantitation by LC–MS. WengN, JianW ( Eds). John Wiley & Sons, NJ, USA (2017).
   Google Scholar
• Ocque AJ , HaglerCE, DifrancescoRet al. Development and validation of a UPLC–MS/MS method for the simultaneous determination of paritaprevir and ritonavir in rat liver. Bioanalysis8 (13), 1353–1363 (2016).
   PubMed Web of Science ®Google Scholar
• Timmermann P . What does GLP mean in regulated Bioanalysis or Biomarker Bioanalysis. Presented at : 9th European Bioanalysis Forum Open Meeting. Barcelona, Spain, 16–19 November 2016.
   Google Scholar
• Yamada Y , HidefumiK, ShionH, OshikataM, HaramakiY. Distribution of chloroquine in ocular tissue of pigmented rat using matrix-assisted laser desorption/ionization imaging quadrupole time-of-flight tandem mass spectrometry. Rapid Commun. Mass Spectrom. 25 (11), 1600–1608 (2011).
   PubMed Web of Science ®Google Scholar
• Grove KJ , KansaraV, PrentissMet al. Application of Imaging Mass Spectrometry to Assess Ocular Drug Transit. SLAS Discov. DOI: 10.1177/2472555217724780 (2017) ( Epub ahead of print).
   PubMed Web of Science ®Google Scholar
• Steuer AE , PoetzschM, KraemerT. MALDI-MS drug analysis in biological samples: opportunities and challenges. Bioanalysis8 (17), 1859–1878 (2016).
   PubMed Web of Science ®Google Scholar
• Turker SD , DunnWB, WilkieJ. MALDI-MS of drugs: profiling, imaging, and steps towards quantitative analysis. Appl. Spectrosc. Rev. 52 (1), 73–99 (2017).
   Web of Science ®Google Scholar
• Fu W , AnB, WangX, QuJ. Key considerations for LC–MS analysis of protein biotherapeutics in tissues. Bioanalysis9 (18), 1349–1352 (2017).
   PubMed Web of Science ®Google Scholar
• Shafaie S , HutterV, CookMT, BrownMB, ChauDYS. In vitro cell models for ophthalmic drug development applications. Biores. Open Access5 (1), 94–108 (2016).
   PubMed Web of Science ®Google Scholar
• Rönkkö S , VellonenKS, JärvinenK, ToropainenE, UrttiA. Human corneal cell culture models for drug toxicity studies. Drug Deliv. Transl. Res. 6 (6), 660–675 (2016).
   PubMed Web of Science ®Google Scholar
• Shen J , BurgessDJ. In vitro–in vivo correlation for complex non-oral drug products: where do we stand?J. Control. Release219, 644–651 (2015).
   PubMed Web of Science ®Google Scholar