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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
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

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