Study Designs
BioPharma Services has completed a wide range of Study Designs for our Sponsors
BioPharma Services’ expert Pharmacokinetics team produces custom Study Designs for a wide variety of clinical trials. Please find a wide selection of our study designs for your review. If the study design you require is not listed, please Contact Us to discover how we can support your clinical trial with our award-winning end to end approach which includes protocol development, clinical execution, bioanalysis, scientific regulatory affairs, data management, and medical writing.
Study Designs
| Study Design Name | Dosage | Formulation |
|---|---|---|
| Abiraterone BE study design Dec 2020 PB updated | ||
| Acalabrutinib Capsule Study Design Aug 2021 [FDA] | ||
| Acamprosate 333 mg DR tablets BE study Design FDA Oct 2021 | ||
| Acarbose Tablets All Agencies BE PD Study Design Oct 2021 | ||
| Acetaminophen Butylscopolamine 500 10mg Tablet EMA BE study design June 2019 | ||
| Acetazolamide Tablet (all agencies) BE design Dec 2021 | ||
| Acitretin Capsule BE design all agencies Sep 2019 PB | ||
| Afatinib Tablet EMA BE Study Design Nov 2020 | ||
| Albendazole Tablets Study Design All Agencies Jan 2017 Updated June 2018 | ||
| Albuterol sulfate 0.09mg MDI Aerosol Inhaler BE FDA Nov 2021 | ||
| Alitretinoin Capsule Study Design AUG 2020 [EMA] | ||
| Alvimopan capsule Study Design FDA Oct 2021 updated | ||
| Amantadine IR Capsules BE Study Design (All Agencies) Jan 2018 | ||
| Ambrisentan tadalafil BE study design EMA Dec 2021 | ||
| Amifampridine tablet All agencies BE study Jun 2019 | ||
| Aminocaproic Acid 1g tablet FDA BE study Design 3 Jan 2019 | ||
| Amlodipine Irbesartan Hydrochlorothiazide Drug Drug Interaction design Apr 2018 | ||
| Amlodipine Lisinopril EMA May 2018 | ||
| Amlodipine Perindopril Indapamide SR FDC EMA BE study design Jan 2022 | ||
| Amoxicillin cap 500mg TPD Jun 2018 | ||
| Amphetamine mixed 30mg ER capsule FDA BE design Dec 2018 | ||
| Amphetamine mixed salts 30mg IR tablet FDA BE design OCT 2019 RD | ||
| Anastrazole 1mg Tablets BE design (EMA) Mar 2019 | ||
| Apalutamide 60 mg Tablet BE Design (FDA) Aug 2021 | ||
| Apixaban Tablet EMA study design April 2020 PB | ||
| Apremilast 30 mg IR tab All agencies BE study design Mar 2019 | ||
| Apremilast 75 mg ER Tablets BE Study Design (EMA & FDA) Aug 2018 | ||
| Apremilast 75 mg ER vs 30 mg IR 505 b2 | ||
| Apremilast Single & SS EMA Design Oct 2019 NR | ||
| Aprepitant Capsule BE Study Design FDA JULY 2020 | ||
| Atorvastatin 80 mg Tablets BE Study Design (All Agencies) Feb 2018 | ||
| Atorvastatin Ezetimibe 80 10mg Tablet EMA BE design Jan 2022 | ||
| Axitinib Tablet BE Study Design UPDATE Jul 2019 RD | ||
| Azelastine Fluticasone Study design All Agencies Jan 2022 | ||
| Azilsartan Chlorthalidone EMA BE study design Nov 2021 | ||
| Azithromycin Oral Suspension BE Study Design Jan 2018 | ||
| Barcitinib FDA BE Design Jan 2022 | ||
| Bempedoic Acid FDA BE study design Jan 11, 2022 | ||
| Betamethasone dipropionate vasoconstrictor study design EMA Jan 2020 updated | ||
| Bexarotene capsules Medichem 75mg EMA BE study design Apr 2021 | ||
| Bilastine 20 mg tab EMA Design Oct 2018 Final | ||
| Bisoprolol Tablets All Agencies Study Design (FDA) Jun 2021 | ||
| Bosentan tablet BE design Oct 2021 (TPD) | ||
| Bosutinib 500mg Study Design EMA Dec 13 021 DY | ||
| Brexpiprazole 2 mg Orally Disintegrating Tablet BE Study Design (FDA) Jul 2019 | ||
| Brexpiprazole 2 mg Orally Disintegrating Tablet BE Study Design (FDA) Jul 2019 Copy | ||
| Brivudine Study Design EMA Feb 2019 RD | ||
| Bromazepam tablet study design EMA Dec 2020 updated PB | ||
| Budesonide ER Capsules 4mg vs Nefecon FDA Study Design Jan 2022 | ||
| Budesonide Formoterol 400.12mcg Dry powder Inhaler BE TPD July 2021 | ||
| Budesonide Formoterol 80 mcg 4.5mcg Dry powder Inhaler BE EMA July 2021 | ||
| Buprenorphine Naloxone Sublingual Tablet BE design (TPD) Nov 2018 | ||
| Buprenorphine Naloxone Sublingual Tablet Study Design for FDA updated Mar 2021 | ||
| Buprenorphine Patch Skin Irritation and Sensitization Study Design June 04 2018 | ||
| Buprenorphine Sublingual tablet Study Design for FDA Apr 2021 | ||
| Buproprion Dextromethorphan FDA BE Study Design Feb 2021 | ||
| Cabozantinib tablet BE Study Design (FDA) | ||
| Cannabidiol Oral solution BE study design FDA EMA Oct 2021 | ||
| Carbamazepine ER CAPSULES Study Design FDA January 2019 RD | ||
| CARBAMAZEPINE ER tablets Study Design FDA February 2019 RD | ||
| Carglumic acid FDA BE Study Design Sep 2020 | ||
| Cariprazine Capsule Study Design AUG 2020 [EMA] | ||
| CBD+THC spray BE study design EMA Oct 2021 | ||
| Cefuroxime 500mg film coated EMA BE study Nov 2018 | ||
| Celecoxib 200 mg amlodipine 10 mg FDC design Jan 2018 | ||
| Chlorpromazine Study Design September 2018 NR RD FINAL | ||
| Chlorthalidone Tablet 25 50 mg TPD BE design June 2021 | ||
| Chlorzoxazone 500 mg tablet FDA Design RD Sep 2019 | ||
| Cilostazol 100mg tablet BE design TPD Jan 2022 | ||
| Clobazam Tablet 20 mg Tablets BE design (FDA) Nov 2019 | ||
| Clonazepam TABLETS EMA Design May 2019 version 1 RD | ||
| Clorazepate Dipotassium FDA BE Study Design Final | ||
| Colchicine 0.6 mg Tablets BE design (FDA) Jul 2021 | ||
| Conjugated Estrogens Vaginal cream FDA BE design Aug 2021 | ||
| Crisaborole Ointment FDA BE Study Design Sep 2019 | ||
| Cyclobenzaprine Tablets BE Study Design January 2011 updated Jan 2018 | ||
| Dabigatran 150 mg Capsule BE Design (EMA) Oct 2019 | ||
| Dabigatran Pre treatment with PPI Study Design EMA Oct 2019 | ||
| Dapagliflozin 10 mg All agencies BE Study Design Mar 2019 | ||
| Dapagliflozin Metformin EMA BE Design Feb 2020 | ||
| Dapagliflozin Metformin TPD BE Design Feb 2020 | ||
| Dapagliflozin Sitagliptin EMA BE Design Apr 2021 | ||
| Dasatinib 100 mg IR tablet FDA Jan 2019 | ||
| Dasatinib 100 mg IR tablet FDA Jan 2020 | ||
| Dasatinib 100 mg IR tablet TGA Jan 2019 | ||
| Dasatinib 100 mg IR tablet TGA Jan 2020 | ||
| Dasatinib 140 mg IR tablet EMA Oct 2021 | ||
| Dasatinib 140 mg IR tablet TPD Jan 2020 | ||
| Deferiprone 1000 mg BID Tab FDA BE design Feb 2022 | ||
| Deferiprone 500 mg and 1000 mg TID Tab FDA BE design Feb 2022 | ||
| Degarelix Depot Subcutaeous Injection (All agencies) Mar 2018 | ||
| Desiccated Thyroid Extract (Levothyroxine) BE design FDA pilot Feb 2022 | ||
| Desloratadine Tablets and ODT Study Design All Agencies Mar 2019 RD | ||
| Desmopressin tablet 3 agencies updated June 2021 | ||
| Desogestrel Ethinyl Estradiol 0.15 0.02mg EMA Feb 09, 2022 | ||
| Desvenlafaxine ER tablets SD and MD BE Design Jan 2020 | ||
| Dexamphetamine IR tablets EMA March 2019 RD | ||
| Dexlansoprazole Capsule Updated Study Design FDA Feb 2020 PB | ||
| Dexlansoprazole delayed release capsule BE design EMA Dec14, 2021 | ||
| Dexmethylphenidate HCl XR Capsules Study Design Feb 2022 | ||
| Diazepam Rectal Gel FDA BE Study design Jan 2019 | ||
| Diazepam Tablet BE Study Design for all agencies Sep 2019 PB | ||
| Diazoxide Suspension FDA Design Apr 2020 | ||
| Diclofenac sodium DR tablet FDA study design Jan 2021 | ||
| Dicycloverine 20 mg Tablets BE design (EMA) | ||
| Diflorasone diacetate BE vasoconstrictor study design (FDA) Oct 2019 | ||
| Dimethyl Fumarate Capsule Study Design EMA Dec 2020 | ||
| Dimethyl Fumarate Capsules Study Design August 2020 [FDA] | ||
| Dimethyl Fumarate Capsules Study Design August 2020 [TPD] | ||
| Diphenhydramine Injectable Suspension BioStudy Results Study Design [FDA] | ||
| Docusate sodim 100mg BE MHRA Jan 2022 | ||
| Dofetilide Mexiletine FDC Study Design Feb 2020 DY | ||
| Dolutegravir and Lamivudine FDA BE Study Design Jan 2019 RD | ||
| Dolutegravir, Tenofovir Alafenamide and Lamivudine 50 25 300 mg Tablets FA FE FDA BE study Sep 2018 | ||
| Donepezil HCl Memantine HCl Capsules Study Design FDA Nov 2021 updated | ||
| Donepezil injectable Study Design Phase 1 April 2020 PB | ||
| DORYX MPC Doxycycline DR Tablets FDA BE study design Sep 2018 | ||
| Doxepin 50 mg capsule BE Study design May 2020 [EMA] | ||
| Doxepin cream 5% FDA Study Design Dec 2018 | ||
| Drospirenone Estradiol All Agencies BE Study Design Updated Jan 2018 | ||
| Droxidopa FDA Study Design Sep 2018 | ||
| Duloxetine 120 mg DR Capsules 505b2 Design (FDA) | ||
| Duloxetine gastro resistant hard capsule 60 mg BE design EMA Dec 2021 | ||
| Dydrogesterone EMA study design Apr 2019 RD | ||
| Edaravone iv vs oral FDA 505b2 Mar 2020 | ||
| Elagolix Tablet EMA BE Design Jan 2021 | ||
| Elagolix Tablet FDA BE Design Jan 2021 | ||
| Eltrombopag Tablet Study Design July 2020 [EMA] | ||
| Empagliflozin EMA BE study design Nov 2021 | ||
| Empagliflozin metformin EMA BE study design Nov 2021 | ||
| Emtricitabine and Tenofovir Alfenamide Study Design OCT 2018 RD | ||
| Emtricitabine tenofovir BE 3 agencies Jan 2018 | ||
| Enalapril Study Design EMA Feb 2020 RD.doc | ||
| Enoxaparin Sodium FDA EMA Study Design Dec 2021 | ||
| Entecavir Tablets All Agencies Study Design June 2013 updated Jan 2015 | ||
| Enzalutamide Capsules BE Study Design (All Agencies) Feb 2018 | ||
| Enzalutamide Study Design Jan 2022 [All Agencies] | ||
| Epinephrine (Adrenaline) solution IM injection BE Study design Dec 2015 updated Jan 2018 | ||
| Eplerenone and Torsemide Drug Drug Interaction design EMA Dec 2021 | ||
| Eplerenone Furosemide EMA hybrid BE Study Design Apr 2021 | ||
| Escitalopram 20mg tablets BE design EMA Dec 2021 final | ||
| Esomeprazole and Naproxen Modified Release Tablets (EMA) BE Design Nov 2018 | ||
| Esomeprazole delayed release BE FDA Study Design Sep 2020 | ||
| Estradiol 1mg Norethindrone Acetate 0.5mg tablet FDA BE design Dec 2018 | ||
| Estradiol and Progesterone FDA Study Design December 182018 Final | ||
| Estradiol Norethindrone acetate 1 0.5 mg Tablet Study Design Feb 2022 | ||
| Estradiol TDDS Skin Irritation Sensitization Design (FDA) Feb 2021 | ||
| Estradiol Vaginal Inserts Clinical Efficacy Design (FDA) | ||
| Estradiol Vaginal Inserts FDA Study Design September 2018 RD3 JH RD4 | ||
| Estradiol vaginal ring BE with PK endpoint Design Mar 2020 | ||
| Ethinyl Estradiol Norethindrone acetate Tablet FDA Design Sep 2021 | ||
| Ethinyl estradiol; Norelgestromin Transdermal (PK & Adhesion) Study Design (FDA) Aug 2019 | ||
| Ethinyl estradiol; Norelgestromin Transdermal Skin Irritation & Sensitization Design (FDA) Aug 2019 | ||
| Etonogestrel Ethinyl Estradiol Vaginal Ring BE design Jun 219 | ||
| Everolimus low dose 0.75 mg Tablets BE Design (FDA) Oct 2018 | ||
| Everolimus low dose 1 mg Tablets BE Design (EMA) Oct 2018 | ||
| Everolimus Tablets 10 mg BE Study Design (All Agencies) Dec 2019 Updated RD | ||
| Exenatide Bydureon BE 3 Agency July 2014 | ||
| Ezetimibe Pitavastatin FDC hybrid EMA Design Jan 2021 | ||
| Favipiravir 200 mg Tablet Study Design Nov 2021 | ||
| Fentanyl Patch Study Design BE Pharmacokinetic Endpoints and Adhesion Study Jan 2018 | ||
| Ferric Carboxymaltose All Agencies BE design Jun 2021 | ||
| Ferric Citrate EMA BE Study Design Serum May 2018 | ||
| Fesoterodine 8 mg 4 mg PR capsule Single & SS EMA Design Nov 2019 | ||
| Finasteride and tadalafil EMA BE Study Design Apr 2019 RD | ||
| Finasteride Tadalafil Drug Drug Interaction design EMA Nov 2020 | ||
| Fingolimod Capsules All Agencies Study Design Jul 2021 | ||
| Flecainide 100mg tablet EMA design Non NTID Oct 2018 | ||
| Fluconazole 200 Tablet BE Study Design TPD & FDA Mar 2018 | ||
| Flucytosine FDA EMA study design Jul 2021 | ||
| Fludrocortisone 0.1mg Tablet EMA Dec 2018 | ||
| Fluticasone Inhaler (MDI) BE Study Design Jan 2018 | ||
| Fluticasone Propionate Nasal Spray Study Design SEP 2020 [FDA] | ||
| Fluticasone Salmeterol Inhalation Products BE design Oct 2018 | ||
| Fluticasone Umeclidinium Vilanterol Powder inhalation FDA BE Feb 2022 | ||
| Folic Acid Solution 505b2 study design FDA PB Aug 2019 | ||
| Formeterol PK profiling Design Feb 2020 Final | ||
| Fosfomycin Solution All Agencies Study Design May 2019 | ||
| Fulvestrant IM FDA pilot BE design 2020 | ||
| G2G BIO Donepezil injectable Study Design Phase 1 April 2020 PB | ||
| Gabapentin Tablets 100mg 400mg EMA Study Design Mar 2021 | ||
| Gilteritinib FDA BE study design Dec 2021 | ||
| Glycopyrronium Inhaler Powder BE design Sep 2019 | ||
| Guanfacine Hydrochloride ER Tab All Agencies BE Study Design Mar 2021 DY updated | ||
| Guanfacine Hydrochloride ER Tab All Agencies BE Study Design Nov 2021 DY updated | ||
| Haloperidol 2mg tablet FDA BE Design 19 Sep 2019 RD | ||
| Human Menopausal Gonadotropin preparation (EMA) BE study design Jan 2021 | ||
| Hydrocodone bitartrate 20mg ER tablet FDA BE study design Nov 2021 | ||
| Hydrocortisone retention enema FDA study design Dec 2021 DY | ||
| Hydroxyurea TPD Study Design Sep 2021 | ||
| Ibrutinib Tablets BE study design FDA Oct 2018 | ||
| Ibuprofen ER 600 mg TPD BE study design Jan 2022 | ||
| Ibuprofen IR capsules BE Study Design FDA Sep 2021 | ||
| Ibuprofen IR tablet BE Study Design All agencies Jan 2018 | ||
| Ibuprofen lysine EMA Study Design Apr 2021 | ||
| Idelalisib Tablet BE study Design (All Agencies) Jan 2018 | ||
| Imatinib Mesylate tablets FDA EMA Feb 2022 | ||
| Indacaterol Glycopyrronium Inhalation Powder BE design (EMA) | ||
| Indapamide Ramipril EMA FEBRUARY 2019 RD | ||
| Indapamide Ramipril EMA Updated Jan 2021 PB | ||
| Indapamide SR EMA BE study Design Jan 2022 | ||
| Indomethacin suppository Study Design Update May 2020 [FDA] | ||
| Inosine Pranobex tablets EMA Study Design Oct 2021 | ||
| Iron Sucrose All Agencies BE design May 2019 Final | ||
| Irritation sensitization study layout.xlsx | ||
| Isotretinoin 10 mg MR Capsules 505(b)(2) Study Design (FDA) | ||
| Isotretinoin Study Design (all agencies) Dec 2021 | ||
| Ivabradine Tablets All agencies BE Study Oct 2019 | ||
| Ivacaftor tablet all agencies BE study design May 2021 | ||
| Ivermectin Study Design FDA Sep 2021 | ||
| Ivosidenib Tablet Study Design SEP 2020 [FDA] | ||
| Labetalol Tablet BE FDA Study Design Apr 2021 update | ||
| Lacosamide 200 mg Tablet EMA FDA BE design Jan 2019 | ||
| Lacosamide syrup study design EMA Apr 2020 RD | ||
| Lamotrigine ER BE Design Jan 2017 updated May 2019.docx | ||
| Lanreotide injection EMA Design Nov 2020 | ||
| Lanreotide injection EMA SS Study Design Mar2021 | ||
| Lansoprazole DR ODT (oral disperse tablet) BE Jan 2018 | ||
| Lanthanum FDA and EMA BE Study design Jul 2021 | ||
| Lapatinib 250mg tablet EMA BE Design Oct 2018 | ||
| Lenalidomide Capsule All agencies BE Jul 2020 | ||
| Lenvatinib Capsules BE Design (FDA) Feb 2019 | ||
| Leuprolide 7.5 mg Long acting Injectable BE Design Jan 2022 | ||
| Levetiracetam ER tablet 750mg FDA May 2019 | ||
| Levodopa carbidopa ER tablet Alcohol interaction FDA Study Design | ||
| Levodopa carbidopa ER tablet FDA Study Design May 2021 | ||
| Levofloxacin Tablets EMA Study Design Jan 2021 | ||
| Levorphanol tablets Study Design FDA FEB 2019 RD | ||
| Levothyroxine 100 mcg Tablet BE design (MHRA) | ||
| Levothyroxine Tablets BE design TPD submission RD | ||
| Lidocain Prilocain Spray EMA BE Study Design Mar 2019 | ||
| Lidocaine Transdermal Patch Plaster FDA EMA BE PK Study Design June 2018 | ||
| Lidocaine Transdermal Patch Plaster FDA EMA Skin Irritation and Sensitization Study Nov 2018 | ||
| Linagliptin EMA Study Design Oct 2020 | ||
| Liothyronine All Agencies Dec 2021 | ||
| Liraglutide (recombinant) BE Study Design EMA Jan 2022 DY | ||
| Liraglutide (recombinant) BE Study Design FDA Jan 2022 | ||
| Liraglutide Inj BE Study Design TPD Jan 2022 | ||
| Lisdexamfetamine Capsule Study Design All agencies Jan 2022 | ||
| Lisdexamfetamine chewable tablets Study Design FDA Mar 2021 DY | ||
| Lisdexamfetamine oral solution Study Design FDA Apr 2021 DY | ||
| Lofexidine HCl 0.18 mg tablets FDA BE study design | ||
| Lorazepam Single & SS EMA Design Dec 06 2019 RD updated | ||
| LORAZEPAM TABLETS EMA Design May 2019 RD | ||
| Losartan Tablets FDA Study Design Jan 2018 | ||
| Lurasidone BE Study Design EMA Apr 2021 | ||
| Macitentan 10 mg tablet EMA BE Design updated Jan 2020 RD | ||
| Macitentan 10 mg tablet TPD BE Design June 2021 | ||
| Mebendazole chewable tablets Study Design FDA FEB 2019 RD | ||
| Meclizine Study Design EMA OCT 2018 NR RD2 | ||
| Medroxyprogesterone acetate IM 150mg All agencies BE Design Apr 2019 | ||
| Meloxicam IV injection BE study design Jun 2021 | ||
| Meloxicam Rizatriptan FDA BE study design | ||
| Mercaptopurine Study Design FDA Feb 2022 | ||
| Mesalamine DR 1200mg BE design FDA Nov 2021 DY | ||
| Mesalamine DR 800 mg BE design FDA Feb 2022 DY | ||
| Mesalamine ER 1g tablet BE design EMA March 2020 PB | ||
| Mesalamine ER 375 mg BE design FDA July 2021 clean | ||
| Mesalamine ER 500 mg Capsule BE design (FDA) Nov 2021 | ||
| Mesalamine PR 1200 mg tablet BE design EMA Nov 2021 DY | ||
| Metformin IR Study Design Jan 2022 | ||
| Metformin XR Tablet Study Design EMA Dec 2020 | ||
| Methylnaltrexone IR Tablet Study Design [FDA] Jun 2021 | ||
| Methylphenidate CHEW ER tab FDA Design Dec 2020 | ||
| Methylphenidate Controlled Release Capsules TPD Study Design Updated Jan 2018 | ||
| Methylphenidate ER Metadate Capsules FDA October 2011 updated July 2019 | ||
| Methylphenidate HCL MR Tablet updated Jun 2019 RD | ||
| Methylphenidate IR Tablets FDA BE Study Design November 2018 | ||
| Methylphenidate Suspension ER tab FDA Design Dec 2020 | ||
| Metolazone FDA BE Design Jun 2021 | ||
| Metoprolol ER FDA BE Design Nov 2020 | ||
| Mexiletine Hydrochloride Capsules FDA and TPD Mar 2018 | ||
| Mianserin Tablet EMA BE Design Dec 2020 PB | ||
| Midazolam tablet FDA BE study Design Dec 2019 | ||
| Midostaurin BE Study Design All agencies Dec 2020 | ||
| Mirabegron ER tablets Study Design FDA September 2019 RD | ||
| Mirabegron PR Tablets BE study design (EMA) Apr 2018 | ||
| Mirtazapine Tablet BE study design Nov 2019 PB | ||
| Misoprostol IR Tablet Study Design JUN 2020 [FDA] | ||
| MMF AET Comparative BA study design Dec 2020 PB | ||
| MMF AET SAD study design Dec 2020 PB | ||
| Model QC 20201124 (1).xlsx | ||
| Mometasone Furoate Formoterol Fumarate Inhalation BE Study Design (FDA) Mar 2018 | ||
| Mometasone Nasal Spray Study Design JUN 2020 [FDA] | ||
| Mometasone Ointment Study Design JUL 2020 [TPD] | ||
| Monomethyl Fumarate ER capsules FDA 505b2 Design Oct 2021 | ||
| Monomethyl Fumarate GenCaps Study Design BE EMA Dec 2020 PB | ||
| Morphine 30 mg IR Tablet FDA study design Jun 2020 PB | ||
| Morphine ER Capsule BE Study design Mar 2018 | ||
| Mosapride Study Design Jan 2018 | ||
| Moxidectin Study Design FDA Jan 2022 | ||
| Mycophenolate Mofetil Suspension BE design FDA Oct 2021 | ||
| Mycophenolic acid BE study design Feb 2018 | ||
| N Acetylcystein Effervescent Tablets Study Design May 2020 [NMPA] | ||
| Nalmefence EMA BE Study Design Nov 2020 | ||
| Naloxone IV Study Design JUL 2020 [FDA] | ||
| Naltrexone tablets Study Design October 2019 RD | ||
| Naproxen gastro resistant Table BE Design EMA Feb 2018 | ||
| Nebivolol 20mg Tablets BE Study design FDA May 2021 | ||
| Neratinib 240 mg tablet All agencies BE study design Aug 2021 | ||
| Nevirapine IR tablet Study Design all agencies Jan 2018 | ||
| Nicotine Oral Spray Solution BE Study design Mar 2018 | ||
| Nilotinib BE design All agencies Mar 15 2018 | ||
| Nimodipine IR 30mg capsule BE study FDA Sep 2021 | ||
| Nintedanib esylate 150mg soft capsule BE design (EMA) June 2019 | ||
| Nitazoxanide FDA May 2018 | ||
| Nitrofurantoin Oral Suspension 25 mg 5ml FDA Study Design Sep 2021 | ||
| Nitroglycerin Sublingual Tablets & Powder Jan 2018 | ||
| Norethindrone Ethinyl Estradiol Capsule FDA BE Design Aug 2019 | ||
| Nortriptyline Capsules BE Study Design All Agencies Mar 2018 | ||
| Nortriptyline Capsules BE Study Design Jul 2021 | ||
| Obeticholic acid 10mg tablet FDA BE design Dec 2021 | ||
| Obeticholic acid 10mg tablet FDA BE design Jan 2022 | ||
| Octreotide Depot IM Inject BE SD Updated Aug 2018 | ||
| Olanzapine Oral dispersible tablet EMA Design Apr 2019 RD | ||
| Olanzapine Oral tablet Study Design FDA Dec 2021 | ||
| Omprazole DR Capsules BE design all agencies Jan 2019 | ||
| Oseltamivir Capsule Study Design JUN 2020 [EMA] | ||
| Osimertinib 80mg tablet FDA and TPD BE Study Design Mar 2019 | ||
| Otilonium bromide tablet BE EMA Dec 2021 | ||
| Oxycodone ER 30 mg insufflation FDA Feb 2022 | ||
| Oxycodone ER 80 mg EMA SS Study Design July 2018 Safety confirmed | ||
| Oxycodone ER 80 mg SD FDA Sept. 2014 updated June 2018 | ||
| Oxymorphone ER BE March 2018 | ||
| Ozanimod FDA EMA BE study design Feb 2021 DY | ||
| Palbociclib Capsule 125 mg BE study EMA Sep 2021 | ||
| Palbociclib Lezotrole tablet 125 mg 2.5mg BE study FA with PPI EMA Feb 2022 | ||
| Palbociclib tablet 125mg BE study EMA Sep 2021 | ||
| Palbociclib tablet 125mg BE study FA with PPI EMA Oct 22, 2021 | ||
| Palbociclib Tablet FDA BE Design Dec 2020 PB | ||
| Paliperidone 6 mg ER Tablets BE design (FDA) Dec 2021 | ||
| Paliperidone IM 25mg Study Design Template Apr 2019 (EMA) | ||
| Paliperidone Long Acting Injection 25mg Study Design (TPD) Jun 2019 | ||
| Pantoprazole Sodium Delayed Release Tablets Apr 2019 | ||
| Paracetamol (acetaminophen) suspension EMA design May 2018 | ||
| Paroxetine ER Tablets FDA Jan 2018 | ||
| Pazopanib BE Design (all Agencies) Updated Jan 2022 | ||
| Perampanel study design for 3 agencies Dec 2020 | ||
| Perindopril arginine and amlodipine Study Design Oct 2021 updated | ||
| Perindopril Indapamide Study Design Dec 2021 | ||
| Phenytoin Oral suspension all agencies Jan 2018 | ||
| Phytonadione injection FDA Study Design updated Jan 2021 | ||
| Pirfenidone Capsule and Tablet all agencies BE design Jan 2018 | ||
| Pirfenidone IR vs ER BE design APR 2018 | ||
| Pirfenidone IR vs SR BE design APR 2018 | ||
| Pitolisant BE study design FDA Feb 2022 | ||
| Ponatinib EMA BE Design Jan 2022 | ||
| Ponatinib FDA BE Design Jan 2022 | ||
| Posaconazole Gastro Resistant Tablets All Agencies Study Design Nov 2019 RD | ||
| Pramipexole 0.375 mg 0.75 mg ER PR BE Design Sept 2017 Updated Jan 2018 | ||
| Pramiprexole Rasagline Design May 2016 updated Sep 2021 | ||
| Pramiracetam Study Design EMA OCT 2019 Final updated | ||
| Prednisone 5 mg DR tab (Sponsor specific) FDA Study Design Jun 2020 (revised) | ||
| Pregabalin CR tablet FDA BE study Design Dec 2019 new n for COVID 19 April 2020 | ||
| Progesterone capsule for oral and vaginal EMA BE design Jul 2021 | ||
| Progesterone Capsules All Agencies Study Design Sep 2021 | ||
| Propafenone Extended Release Capsules FDA Study Design Jan 2018 | ||
| Propofol Injectable BE Design 505 b2 Mar 2021 | ||
| Prucalopride 2 mg Tablets TPD BE Feb 2019 | ||
| Pyrantel Embonate Chewable Tablet Study Design JUN 2020 [EMA] | ||
| Pyridostigmine Bromide Prolonged Release Tablets 505b2 study Design Jul 2021 | ||
| Pyrimethamine tablets Study Design FDA Aug 2019 RD | ||
| Quetiapine IR 25 mg Capsule FDA EMA May 2019 | ||
| Ramipril Indapamide EMA BE study design Nov11 2021 | ||
| Ramipril Indapamide SR EMA BE study design Nov 2021 | ||
| Ranolazine XR Tablet Study Design EMA May 2021 final | ||
| Regorafenib 40mg tablet EMA BE Study Design May 2021 | ||
| Ribociclib tablet FDA BE study Design Dec 2020 | ||
| Rifaximin Tablet 200 mg Study Design August 2020 [FDA] | ||
| Rifaximin Tablet 200 mg Study Design May 2020 [EMA] | ||
| Rifaximin Tablet 550 mg Study Design August 2020 [FDA] | ||
| Risperidone 25 mg Long Acting Injectable BE Design Oct 2019 | ||
| Rivaroxaban 10 & 20mg tablet Nov 2020 [All agencies] | ||
| Rizatriptan ODT BE FDA and EMA Sep 2018 | ||
| Ropinirole XL Tablet BE Study Design FDA Jan 26, 2018 | ||
| Rosuvastatin 40mg tablet All agencies Feb 2019 | ||
| Rosuvastatin Candesartan Study Design EMA Jan 2022 | ||
| Rosuvastatin Metformin SR 10 mg 1000 mg Tablets DDI design (EMA) Oct 2018 | ||
| Rosuvastatin Ramipril 20 10 mg tablet EMA Hybrid study Design Nov 2019 | ||
| Rotigotine transdermal patch design (EMA) SD MD PB Aug 2020 | ||
| Rotigotine transdermal patch design (EMA) Skin irritation and sensitization PB Aug 2020 | ||
| Roxadustat Capsule Study Design JUN 2020 [NMPA] | ||
| Rupatadine Solution 1mg mL EMA BE Study Design April 2019 (correct typo) | ||
| Rupatadine Tablets EMA Study Design April 2019 updated by RD | ||
| Ruxolitinib Study Design FDA Sep 2021 | ||
| Sacubitril Valsartan Tablets BE Study Design Feb 2022 | ||
| Sacubitril Valsartan Tablets BE Study Design May 2021 [EMA] | ||
| Sacubitril Valsartan Tablets BE Study Design Sep 2021 | ||
| Safinamide 100 mg Tablets BE design (FDA) | ||
| Saxagliptin 5mg IR tablet EMA Study Design Oct 2018 Final | ||
| Saxagliptin Metformin 2.5mg 850 mg & 1000 mg IR tablet EMA design Oct 18 | ||
| Selegiline Transdermal PK & adhesion (FDA) Design Dec 2020 | ||
| Selegiline Transdermal PK & adhesion Design Dec 2020 | ||
| Selegiline Transdermal Skin irritation and sesitization Design Jul 2019 | ||
| Selexipag 1.6 mg IR Tablet EMA Design Dec 2021 | ||
| Selexipag 400mcg, 1600 mcg IR Tablet ELPEN EMA Design Jan 2022 | ||
| Semaglutide injection BE for EMA study design | ||
| Semaglutide tablet BE for FDA study design | ||
| Sertraline EMA study design Nov 2020 PB | ||
| Servier project gliclazide MR BE Study Design Sep 2020 | ||
| Sildenafil EMA Study Design Jan 2019 | ||
| Silodosin capsule All Agencies BE Feb 2019 | ||
| Siponimoid BE study design FDA Oct 2021 | ||
| Sitagliptin Updated Study Design All agencies Oct 2021 | ||
| Sitaglitan Metformin IR Tablets Study Design for all agencies Nov 2021 | ||
| Sitaglitan Metformin XR Tablets FDA NMPA BE Design Dec 2021 | ||
| Sitaglitan Metformin XR Tablets TPD BE Design Jan 2021 | ||
| Sodium Oxybate 9g Hikma FDA Design Mar 01 2021 | ||
| Sofosbuvir tablet all agencies Oct 2021 | ||
| Solifenacin Succinate Tablet FDA Study design Sep 2019 PB | ||
| Solifenacin succinate Tamsulosin hydrochloride MR Tablets EMA BE Study Design Jul 2021 | ||
| Sorafenib Tablets BE Design (All agencies) Feb 2019 | ||
| Spironolactone Tablets All Agencies Study Design Sep 2016 Updated Feb 2018 | ||
| Sumatriptan SQ Injection FDA study design Oct 2019 PB | ||
| Sumatriptan tablet EMA study design Jan 2021 | ||
| Sunitinib Capsules BE design All Agencies Jul 2021 | ||
| Sunitinib Tablets BE all agency design Feb 2018 | ||
| Suvorexant tablet FDA BE design Feb 2022 | ||
| Tacrolimus Cap FDA BE study Design Jan 2022 | ||
| Tacrolimus ER tab FDA BE study Design Jan 2022 | ||
| Tadalafil Study Design EMA Jan 2019 RD | ||
| Tadalafil Tablets BE Study Design All Agencies Jan 2018 | ||
| Tafamidis 61 mg capsule BE design FDA May 2021 | ||
| Tapentadol SR tablets All agency Study Design Feb 2022 | ||
| Teduglutide powder for injection EMA BE study design Mar 2021 | ||
| Telmisartan Indapamide EMA BE study design June 2021 | ||
| Telotristat Etiprate Tablets BE Study Design (EMA & FDA) | ||
| Tenofovir Alfenamide Study Design FDA DEC 2018 RD | ||
| Tenofovir Disoproxil Fumarate 300mg Tablets BE study TPD Sep 2021 | ||
| Teriflunomide 14 mg Tab All agencies BE study Design Nov 2019 | ||
| Teriparatide 20 µg SC Injection EMA Study Design | ||
| Testosterone ER Transdermal FDA Study Design Skin test Study Jan 2018 | ||
| Testosterone Spray Skin test Study Design for Celista March 2018 | ||
| Tetracycline Kit 500 mg Study Design (FDA) | ||
| Thalidomide Capsule All Agencies Mar 2018 | ||
| THC CBD Capsules Comparative BA Design for Tilray Mar 2019 | ||
| THC CBD ODT Taste study design updated Jun 2019 RD3 | ||
| Ticagrelor 90 mg tablet EMA BE study designs April 2021 | ||
| Timonacic Acid Pilot for Alvogen EMA Nov 2018 JH SL | ||
| Tiopronin Delayed Release 300 mg BE design (FDA) Dec 2019 | ||
| Tiotropium Bromide Inhalation Powder FDA BE Design Apr 2020 | ||
| Tofacitinib ER tablet All agencies Study Design Feb 2022 | ||
| Tofacitinib IR 10mg tablet EMA Study Design Aug 2021 | ||
| Tolvaptan Tablets Study Design All Agencies Dec 2020 | ||
| Topiramate ER Capsule Study design FDA Oct 2020 | ||
| Tramadol Dexketoprofen 75 mg 25mg EMA BE study design Jan 2022 | ||
| Tranylcypromine Tablet EMA BE Design Mar 2021 (2) | ||
| Trazodone ER EMA BE Design Mar 2021 | ||
| Triamcinolone Acetonide Nasal Spray All Agencies Feb 2019 | ||
| Triazolam tablets Study Design Feb 2022 | ||
| Trientine 250 mg Capsules BE Design Jan 2018 | ||
| Trimebutines film tablet 100mg EMA Design Aug 2018 | ||
| Trospium Chloride XR 60 mg Capsule BE Study Design FDA Feb 2018 | ||
| Ulipristal tablet BE study Design Updated Sep 2018 | ||
| Ursodiol IR tab FDA Study Design May 2020 | ||
| Valbenazine 80 mg capsule BE design FDA June 2019 | ||
| Valsartan HCTZ NMPA BE Design Nov 2019 | ||
| Varenicline Pilot EMA 2mg SR vs 1mg IR Apr 2018 RC | ||
| Varenicline steady state study design EMA 2mg SR vs 1mg IR Apr 2018 | ||
| Varenicline Tablet hybrid EMA study design May 2020 PB rev | ||
| Varenicline Tablets Steady State Study Design (EMA Hybrid Submission) | ||
| Venetoclax 400mg Tablet Study Design Feb 2022 [EMA] | ||
| Venetoclax Tablet Synthon Study Design Feb 2022 [EMA] | ||
| Venetoclax Tablet Synthon Study Design Feb 2022 [FDA] | ||
| Vigabatrin FDA BE study Design Mar 2021 | ||
| Vigabatrin FDA BE study Design Oct 2020 | ||
| Vildagliptin Metformin EMA BE study Design Apr 2020 | ||
| Vildagliptin Tablets Hybrid 505b2 BE Study Design Dec 2019 | ||
| Vismodegib BE FDA EMA study design Jun 2021 | ||
| Vortioxetine Tablet EMA study design Nov 2021 | ||
| Vortioxetine Tablet TPD study design May 2020 PB | ||
| Zolpidem tartrate ER tablet FDA Feb 2020 PB | ||
| Zonisamide 3x100mg Cap vs 300mg tab EMA Hybrid design Apr 2020 |
Schedule a Discovery Call
Learn how BioPharma Services can be your trusted clinical trial partner.